Journal of Cranio-Maxillo-Facial Surgery xxx (2016) 1e11

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Journal of Cranio-Maxillo-Facial Surgery

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Implant supported dental rehabilitation following segmental

mandibular reconstruction- quality of life outcomes of a prospective
randomized trial
Vinay V. Kumar a, b, *, P.C. Jacob a, Supriya Ebenezer c, Moni A. Kuriakose a,
Vikram Kekatpure a, Amresh S. Baliarsing d, Bilal Al-Nawas b, Wilfried Wagner b
a
Head and Neck Institute, Mazumdar Shaw Cancer Center, Narayana Health, Bommasandra, Bangalore, India
b
Department of Oral and Maxillofacial Surgery-Plastic Surgery, University Medical Center of Johannes Gutenberg University, Mainz, Germany
c
Department of Periodontics, M. R. Ambedkar Dental College & Hospital, Bangalore, India
d
Department of Plastic and Reconstructive Surgery (Head: Prof. Dr. A. S. Baliarsing), BYL Nair Charitable Hospital and Topiwala National Medical College,
Mumbai, India

a r t i c l e i n f o a b s t r a c t

Article history: Purpose: The primary objective of this study was to assess the difference in quality of life (QoL) in pa-
Paper received 16 January 2016 tients with dental rehabilitation using two or four implant-supported overdentures following segmental
Accepted 6 April 2016 mandibulectomy defect reconstruction with bula free ap.
Available online xxx
Material and methods: This prospective, parallel designed, randomized clinical study was conducted with
a 1:1 ratio. At baseline, all participants already had bula ap reconstruction for segmental defects of the
Keywords:
mandible and rehabilitation with conventional (non-implant supported) removable partial dentures. The
Dental implants
participants were then randomized into two groups. Group I received implant supported overdentures
Free bula ap
Quality of life
on two implants, and Group II received four implants. QoL outcomes were evaluated using standardized
Oral cancer questionnaires (EORTC_QLQ c30, H&N35, OHIP, DSI). Outcomes of treatment were evaluated at 6 months
Rehabilitation (T1) and 1 year (T2) following rehabilitation.
Mandible reconstruction Results: A total of 52 patients were randomized into two treatment groups (26 each). After accounting
for the loss to lack of follow-up, 22 patients in Group I and 24 patients in Group II were evaluated for QoL
at the end of the study. There was a signicant improvement in QoL with implant-assisted dental
rehabilitation. However there were no signicant differences in QoL between the two-implant and four-
implant groups.
Conclusion: Implant-supported removable overdentures improve QoL outcomes in patients with
reconstructed mandibles. This study showed no signicant difference in QoL outcomes in patients with
two- or four-implant supported removable prostheses.
2016 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights
reserved.

1. Introduction trauma), the bula free ap is a reconstructive option of choice

In patients who undergo segmental resection of the mandible
(e.g., for benign or malignant tumors, osteomyelitis, or severe
* Corresponding author. 37, Lazar Layout, Frazer Town, Bangalore 560005, Kar-
nataka, India.
E-mail addresses: veezo@rediffmail.com (V.V. Kumar), pcjacob66@gmail.com
(P.C. Jacob), supriyaebenezer@gmail.com (S. Ebenezer), makuriakose@gmail.com
(M.A. Kuriakose), kvikram2000@gmail.com (V. Kekatpure), amresh_baliarsing@
hotmail.com (A.S. Baliarsing), Al-Nawas@uni-mainz.de (B. Al-Nawas), wilfried.
wagner@unimedizin-mainz.de (W. Wagner).
(Hidalgo and Pusic, 2002). The nal goal of treatment of patients
with pathologic conditions that require reconstruction of the
mandible is optimal functional and esthetic rehabilitation (Holzle
et al., 2007; Anne-Gaelle et al., 2011). Despite signicant im-
provements in reconstructive surgery, dental and masticatory
rehabilitation results remains suboptimal (Urken et al., 1991;
Vaughan et al., 1992). Recent emphasis on quality of life (QoL) has
focused attention on improvement of functional outcomes along
with esthetic results in patients requiring reconstructive surgery of
the jaws (Kreeft et al., 2009; Albornoz et al., 2013; Hutcheson and
Lewin, 2013).

http://dx.doi.org/10.1016/j.jcms.2016.04.013
1010-5182/ 2016 European Association for Cranio-Maxillo-Facial Surgery. Published by Elsevier Ltd. All rights reserved.

Please cite this article in press as: Kumar VV, et al., Implant supported dental rehabilitation following segmental mandibular reconstruction-
quality of life outcomes of a prospective randomized trial, Journal of Cranio-Maxillo-Facial Surgery (2016), http://dx.doi.org/10.1016/
j.jcms.2016.04.013
2 V.V. Kumar et al. / Journal of Cranio-Maxillo-Facial Surgery xxx (2016) 1e11
QoL studies have demonstrated that patients consider chewing,
swallowing, and speech to be of importance after reconstructive
surgery. Patients' perceptions of difculty in eating, prolonged meal
times, messy eating, as well as the need for special preparations of
food are associated with depression and decreased social interac-
tion (List et al., 1990; Rogers et al., 1999; Rogers et al., 2002; Shaw
et al., 2005). Dental and oral rehabilitation play major roles in the
feeling of well-being and oral health-related quality of life
(OHRQoL) (Smolka et al., 2008; Anne-Gaelle et al., 2011; Dholam
et al., 2011; Bodard et al., 2015).
Successful oral rehabilitation of patients with a reconstructed
mandible is challenging. Conventional methods of prosthetic
rehabilitation rely solely on remaining teeth and tissue for support,
retention, and stability (Weischer et al., 1996). This method often
produces limited functional benets (Buchbinder et al., 1991;
McGhee et al., 1997; Mericske-Stern et al., 1999; Garrett et al.,
2006). Insufcient bone height, decreased vestibular space, and
suboptimal condition of the soft tissue overlying the bone graft
creates an unfavorable environment for the tissue-borne pros-
thesis. In addition, irradiated oral mucosa is frequently unable to
tolerate the pressure and friction created by the acrylic base of the
denture. The xerostomia often encountered after radiation reduces
the patient's ability to wear removable dentures (Buchbinder et al.,
1991; McGhee et al., 1997; Mericske-Stern et al., 1999). Therefore,
for many patients, an implant-supported prosthesis offers more
effective rehabilitation, including improvement of function as well
as esthetics (Schmelzeisen et al., 1996; Esser and Wagner, 1997;
tz KA et al., 2000; Shaw et al., 2005).
Schliephake et al., 1999; Gro
Although there are numerous reports relating to oral rehabili-
tation with dental implants after mandibular free ap reconstruc-
tion, most of these studies have the drawbacks of being
retrospective in nature (Bodard et al., 2015; Hakim et al., 2015;
Shaw et al., 2005), having an insufcient sample size (Garrett
et al., 2006; Dholam et al., 2011), or being based on varying types
of prosthetic rehabilitation (Tang et al., 2008; Raoul et al., 2009).
Osseointegrated dental implants have a high level of evidence to
support their use in nonreconstructed patients (Klein et al., 2009)
as well as in an edentulous population in which there are denitive
guidelines on the number of implants needed for satisfactory
function of implant-supported mandibular overdentures
(Wismeijer et al., 1997; Feine et al., 2002; Timmerman et al., 2004).
However, there is only limited evidence for the benet of implant-
supported overdentures in patients with reconstructed mandibles
(Shaw et al., 2005; Tang et al., 2008).
It has been suggested that implant-supported overdentures in
reconstructed jaws can be stabilized with as few as two implants
(Raoul et al., 2009; Korfage et al., 2014). However, some studies
suggest the need for four implants to achieve maximal implant
support for the prosthesis and to relieve the vulnerable underlying
soft tissues (Weischer et al., 1996; Schoen et al., 2008). It has also
been reported that in a reconstructed mandible it is preferable to
place a greater number of implants because if there is a single
implant failure, other implants may still be able to adequately
support the restoration (Schliephake et al., 1999). Hence, at present,
there is a lack of consensus in the literature regarding improvement
in QoL with dental implant-supported rehabilitation as well as the
minimum number of implants required.
2. Material and methods
2.1. Study objectives
The primary objective of this study was to compare QoL and
denture satisfaction outcomes in patients who had two or four
Please cite this article in press as: Kumar VV, et al., Implant supported dental rehabilitation following segmental mandibular reconstruction-
quality of life outcomes of a prospective randomized trial, Journal of Cranio-Maxillo-Facial Surgery (2016), http://dx.doi.org/10.1016/
j.jcms.2016.04.013
implant-supported dental rehabilitation following segmental
mandibular reconstruction with free bula ap.
The secondary objective of this study was to assess the differ-
ence in QoL between the baseline value (with conventional, non-
implant-supported removable partial dentures) and the nal
treatment outcome with implant-supported removable partial
overdentures in patients who had undergone resection followed by
reconstruction of the mandible using free bula ap.
2.2. Trial design
This prospective, randomized clinical study was conducted with
an equal allocation ratio. The participants were randomized into
two study groups: one group received implant supported over-
dentures on two implants (Group I), and the other group received
implant supported overdentures on four implants (Group II), which
were placed in the previously reconstructed mandible (Fig. 1).
2.3. Setting and study population
The study was conducted in a tertiary care referral hospital
(Department of Head and Neck Surgical Oncology, Mazumdar Shaw
Cancer Center, Narayana Health City, Bangalore, India) as well as in
a teaching hospital (M.R. Ambedkar Dental College & Hospital,
Bangalore, India) from May 2012 to November 2014. The study
included patients referred from cooperating tertiary care centers
and private clinics.1 All patients who had undergone resection of
the mandible followed by reconstruction using free bula ap were
assessed for eligibility for the study. The assessments for eligibility
were performed by a single surgeon (V.V.K.) between May 2012 and
August 2013.
2.4. Recruitment of patients
Reconstruction patients were informed about the study design
as approved by the Registered Institutional Review Board and
Ethical Committee of Narayana Hrudayalaya (NH/IRB-CL-2012-
021). Written informed consent was obtained from all patients
wishing to participate. Primary inclusion and exclusion criteria
were reviewed before radiographic examination and are listed in
Table 1. As part of standard of care, the patients meeting the in-
clusion and exclusion criteria underwent panoramic radiography
and computed tomography to determine whether the bone height
and bony relation of the reconstructed neo-mandible (bula) met
the secondary inclusion criteria (Table 1). If all primary and sec-
ondary inclusion criteria were met, the patients were included in
the study.
2.5. Interventions and randomization
The selected patients were randomly assigned to one of the two
treatment groups by computer-generated block randomization
with a block size of four. The code was sealed in an envelope that
was sequentially numbered and was opened only upon inclusion of
the patient in the study. Participants were assigned to the respec-
tive groups based on the concealed allocation sequence (Fig. 1).
1
(Tertiary centers: Dept. Plastic and Reconstructive Surgery, BYL Nair Charitable
Hospital & Topiwala National Medical College, Mumbai, India; Dept. of Plastic and
Reconstructive Surgery, St. Johns Hospital and Research Center, Bangalore, India;
Department of Dentistry, Agroha Medical College and Research Center, Agroha,
Haryana, India; Department of Oral and Maxillofacial Surgery, Mahaveer Jain
Hospital, Bangalore, India) (Private Clinics: Oracare dental clinic, Bangalore, India;
Treatwell Dental Care Clinic, Kolkatta, India).
 V.V. Kumar et al. / Journal of Cranio-Maxillo-Facial Surgery xxx (2016) 1e11 3

2.6. Implant insertion

After patients were allocated to the respective randomized

groups, implants were inserted as per protocol of the manufac-
turers. A single clinician (V.V.K.) performed all implant insertions.
In patients who had not undergone radiotherapy or who had
done so more than 1 year previously, if sufcient primary implant
stability was achieved (Implant Stability Quotient [ISQ] > 65)
(measured using Mentor TM instrument) (Osstell AB, Go teborg,
Sweden), the existing dentures were immediately loaded onto the
implants using a retentive anchor and elliptical matrix with the
help of denture-relining material (Rebase II, Tokoyama, Japan). In
patients who had a history of recent radiotherapy (within 1 year),
or in cases in which any of the implants showed primary stability
values less than or equal to ISQ 65, the implants were loaded only
after 6 months, after the attainment of sufcient implant stability.
In such cases, implants were left for submerged healing, and a
second surgical procedure was performed to uncover the implants.
The existing denture, after relining, functioned as an interim
denture.

2.7. Soft tissue management

Peri-implant soft tissue management was carried out at the

Fig. 1. Diagrammatic representation of the study protocol. PWRM Patients with
reconstructed mandibles (free bula ap); EORTC QLQ-C30 European Organization
for Research and Treatment of Cancer Quality of Life Questionnaire version 3; H&N
35 Quality of Life QuestionnaireHead and Neck 35; OHIP Oral Health Impact
Prole; DSI Denture Satisfaction Index.
Group I patients had two implants and Group II had four im-
plants that were inserted into the reconstructed mandible. All of
the implants used for the study were soft tissue level implants of
the same type, with similar diameters and similar lengths (Strau-
mann Standard Plus Implant SLActive, Straumann AG, Basel,
Switzerland 4.1 mm
10 mm) (Fig. 2).
same time of implant loading, using appropriate techniques, i.e.,
vestibuloplasty with split thickness skin grafts or palatal grafts or
subperiosteal dissection with denture guided epithelial regener-
ation (Kumar et al., 2015a,b).
Standard preoperative and postoperative treatment consisted of
analgesics and chlorhexidine 0.2% mouth rinses and antibiotics.
Sutures were removed after approximately 1 week following
surgery.
2.8. Dentures
In all instances, after 6e8 months of using the interim dentures,
denitive dentures were provided to the patients. The denitive
overdentures were also retained by the use of retentive anchors

Table 1
Study inclusion and exclusion criteria.

Preliminary inclusion criteria (before radiographic examinations):

 Partially dentate patients who had undergone reconstruction of a resection defect of the mandible by free bula ap.
 Patients should have remaining natural dentition or adequate functioning of the remaining dentition on the native/non-affected side.
 The bony defect should be an L or C or LC or LCL defect as per Jewers classication system (Jewer et al., 1989): L defect results when the lateral half of the mandible
would be resected without involvement of the condyle and not crossing the midline, and C defect is a central defect crossing the midline without involvement of the
condyle LC and LCL defects are a combination of L and C defects.
 The soft tissue defect should be minimal or of Class A, C, or AC of the Shpitzer et al. classication system (Shpitzer et al., 1997). Class A represents a defect of the lateral
mandibular gingiva with or without oor of the mouth and without involvement of the tongue; Class C represents a defect of the anterior mandibular gingiva with or
without oor of the mouth without involvement of the tongue; and Class AC is a combination of both lateral and anterior mandibular gingiva without involvement of
oor of the mouth and without involvement of the tongue.
 Patients should have been provided dentures (without implant support) at least 3 months prior to the study recruitment. Provisions were also made for patients who
otherwise met the inclusion criteria but whose prostheses were judged not to be technically acceptable. They were referred for denture revision or for new dentures and
offered the possibility to be examined again for possible inclusion in the trial if the dentures could be worn at least three months before the recruitment.
Exclusion criteria:
 Patients with local and/or systemic contraindication for implantation (history of radiotherapy will not be considered as a contraindication for implantation). Local
contraindications included (but were not limited to) infection at the implant site, poor quality of bone at the implant site, poor union of the grafted bone to the
native mandible and presence of the vascular pedicle supply to the grafted bone at the vicinity of implant placement that may jeopardize the vascular supply to the
grafted bone. Systemic contraindications included (but were not limited to) uncontrolled diabetes, patients on intravenous bisphosphonate therapy and severe
cardiovascular disease.
 Completely edentulous patients.
 Patients with defects involving mandibular condyles.
 Patients with defects involving the tongue, tonsils and palate.
Secondary inclusion criteria (after CT Scan and Orthopantomograms):
 Favorable inter-ridge relation of the reconstructed hemi-mandible to allow adequate functional rehabilitation with implant-supported prosthesis (as seen by CT scans
and panoramic radiographs).
 Sufcient bone in the reconstructed mandible to place implants of 4.1 mm diameter
10 mm length without augmentation procedures.

Please cite this article in press as: Kumar VV, et al., Implant supported dental rehabilitation following segmental mandibular reconstruction-
quality of life outcomes of a prospective randomized trial, Journal of Cranio-Maxillo-Facial Surgery (2016), http://dx.doi.org/10.1016/
j.jcms.2016.04.013
4 V.V. Kumar et al. / Journal of Cranio-Maxillo-Facial Surgery xxx (2016) 1e11
Fig. 2. Panorex radiographs showing Group I and Group II. A and D are Group I patients with two implants placed in the reconstructed mandible, whereas B and C are Group II
patients with four implants placed in the reconstructed mandible.
and elliptical matrices. In all patients, a removable prosthesis was
provided replacing up to the rst molar on the reconstructed side.
All of the prosthetic work was done by a single team led by a
maxillofacial prosthodontist (P.C.J.). Patients were placed on regular
follow-up protocols and were seen by a team consisting of a sur-
geon (V.V.K.), prosthodontist (P.C.J.), and periodontist (S.E.).
2.9. Outcome measures
The primary and secondary outcomes measured in the study
include the QoL of the patients as evaluated by standardized and
validated questionnaires:
 Version 3.0 of QLQ-C30 (Quality of Life Questionnaire-Core 30)
(Aaronson et al., 1993) and QLQ-H&N35 (Quality of Life
Questionnaire-Head & Neck 35)eEORTC (European Organiza-
tion for the Research and Treatment of Cancer) (Bjordal et al.,
1994a,b);
 Oral Health Impact Prole-14 (Slade, 1997) (OHIP-14); and
 Overall denture satisfaction index (Vervoorn et al., 1988).
All the above questionnaires have been tested and found to
possess the required standards for validity and reliability (Aaronson
et al., 1993; Osoba et al., 1994; Kaasa et al., 1995) (Bjordal et al.,
1999; Sherman et al., 2000) (Slade, 1997).
Patients were guided to complete the questionnaires at baseline
(before implant placement surgery), at 6 months following the
interim denture delivery (recorded as T1), and at 6 months
following the denitive denture delivery, which corresponds to 12
months following implant supported dental rehabilitation (recor-
ded as T2) (Fig. 1).
2.10. Sample size determination
There were no existing estimates of pre- or post-implant-related
OHRQoL outcomes in this patient population (consisting of patients
with benign or malignant disease, whose mandible was
Please cite this article in press as: Kumar VV, et al., Implant supported dental rehabilitation following segmental mandibular reconstruction-
quality of life outcomes of a prospective randomized trial, Journal of Cranio-Maxillo-Facial Surgery (2016), http://dx.doi.org/10.1016/
j.jcms.2016.04.013
reconstructed using a free bula ap) to provide the basis for power
analysis to determine the sample size. Hence, the sample size was
estimated based on the probable number of patients that could be
recruited in a reasonable amount of time. A total sample size of
about 50e60 patients was considered possible in a recruitment
period of approximately 15 months. Considering a drop-out rate of
15%, the plan was to evaluate the remaining patient data to reach a
meaningful database for this pilot study.
2.11. Statistical analyses
The primary outcome measures were the HRQoL, OHIP, and
Denture Satisfaction Index outcomes. Continuous variables were
reported using the mean and standard deviation (SD) for the nor-
mally distributed variables; otherwise the median and interquartile
range were used. Categorical variable were reported using numbers
and percentages. Chi-square tests were used to nd the association
between categorical variables. To check for equality of the groups at
baseline, independent t-tests (for normally distributed data) or
ManneWhitney U tests (for non-normally distributed data) were
used to compare the scores of the two groups from the
questionnaires.
Analysis of variance was used to compare the differences be-
tween more than two groups of means. A general linear model for
repeated measures was used to assess differences in HRQoL over
time (baseline, T1, and T2); between the two implant groups and
also between patients with and without radiotherapy. All analysis
was done using SPSS version 18.0. Statistically signicance was set
at the 5% level (p < 0.05).
3. Results
3.1. Patient allocation
Fig. 3 shows the CONSORT ow chart of the study. Of 129 pa-
tients assessed for the study, 77 were excluded because they did
not fulll the inclusion criteria (69 patients), refused enrollment in
 V.V. Kumar et al. / Journal of Cranio-Maxillo-Facial Surgery xxx (2016) 1e11 5

Fig. 3. CONSORT diagram for participant ow of the study.

the study (two patients), or were unable to attend the follow-up
visits (six patients). A total of 52 patients were randomized into
the two treatment groups (26 each). All patients received the
intended treatment. Two patients of both groups were lost to
follow-up for reasons unrelated to treatment. Two patients from
Group I were excluded from the study due to superior barrel ne-
crosis (1 patient) and implant failure (1 patient). Hence, 22 patients
in Group 1 and 24 patients in Group II were evaluated at the end of
the study.
Recruitment of subjects began on 1 July 2012 and continued
until 19 July 2013. The last patient measured for recording of T2
measurements was in October 2014. The trial ended after all pa-
tients enrolled for the study had been recruited.
3.2. Baseline data
Table 2 shows the baseline demographic and clinical charac-
teristics of the patients of each group of the study. There were no
signicant differences in these characteristics between patients in
the two groups.
3.3. Primary objective
At baseline, all outcome parameters were comparable in both
the groups, except for fatigue and nutritional supplements, for
which the two-implant group had statistically signicant higher
values than the four-implant group. At 6 months following pros-
thesis delivery, there were no statistically signicant differences in
outcome measures except for emotional functions, social functions,
and HN felt ill, for which the two-implant group performed better
than the four-implant group. At 12 months following prosthesis
delivery, there were no statistically signicant differences between
the two groups.
3.4. Secondary objective
Outcome measures at different time points (irrespective of
treatment group).
As shown in Table 4, irrespective of the number of implants used
to support the dental prostheses, all patients had better functional
outcomes when they were provided implant-supported prostheses
as compared to conventional (non-implant-supported) removable
prostheses in regard to most parameters evaluated. There were no
differences in regard to constipation, diarrhea, and use of feeding
tubes. No patients in the study used feeding tubes at any time point
of the study.

3.3.1. Outcome measures between the two groups
Table 3 summarizes the outcome measures (EORTC QLQ c 30,
EORTC H&N 35, OHIP, and DSI) of the two groups at three different
time points: T0 (baseline), T1 (6 months following prosthesis de-
livery), and T2 (12 months following rst prosthesis delivery).
3.5. Ancillary analysis
Because radiotherapy has been documented to affect QoL out-
comes, a comparison between patients with and without radio-
therapy was performed (Table 5). Patients who underwent

Please cite this article in press as: Kumar VV, et al., Implant supported dental rehabilitation following segmental mandibular reconstruction-
quality of life outcomes of a prospective randomized trial, Journal of Cranio-Maxillo-Facial Surgery (2016), http://dx.doi.org/10.1016/
j.jcms.2016.04.013
6 V.V. Kumar et al. / Journal of Cranio-Maxillo-Facial Surgery xxx (2016) 1e11

Table 2
Baseline characteristics of each group: Table 2 describes baseline characteristics of each group (Group I- 2 implant supported overdenture and Group II- 4 implant supported
overdenture). N number; % percentage; SD standard deviation; Soft tissue classication type (modied from Shpitzer et al., 1997): Class A: defect of the lateral
mandibular gingiva without involvement of the tongue; Class C: defect of the anterior mandibular gingiva with or without involvement of oor of the mouth without
involvement of the tongue; and Class AC is a combination of both lateral and anterior mandibular gingiva with or without involvement of oor of the mouth without
involvement of the tongue; Bone classication type according to Jewer et al. (1989): L defect of the lateral half of the mandible without involvement of the condyle and not
crossing the midline, and C defect is a central defect crossing the midline, without involvement of the condyle, LC combination of L and C defect, LCL combination of a LC
and L (opposite side) defect.

Characteristic Group I Group II P value

N (%) or N (%) or

Mean (SD) or Mean (SD) or

Mode (range min, range max) Mode (range min, range max)

Sex:
Male 13 (28.2%) 20 (43.5%) 0.068
Female 9 (19.6%) 4 (8.7%)
Age (in years) 34.3 (12.7) 36.5 (SD 12.4) 0.913
Involved side:
Right 8 (17.4%) 10 (21.7%) 0.657
Left 11 (23.9%) 9 (19.6%)
Bilateral 3 (6.5%) 5 (10.9%)
Soft tissue defect classiication type:
A 9 (19.6%) 5 (10.9%) 0.323
C 1 (2.1%) 1 (2.2%)
AC 12 (26.1%) 18 (39.1%)
Bone defect classication type:
L 7 (15.2%) 6 (13.1%) 0.847
LC 9 (19.6%) 10 (21.7%)
LCL 6 (13%) 8 (17.4%)
Number of teeth replaced:
Mode (range) 6 (3, 11) 6 (4, 12) 0.451
Length of reconstructed mandible:
in mm (Ave mean, SD) 94.8 (SD 40.6) 110.3 (SD 30.3)
Reason for resection:
Osteomyelitis 1 (2.2%) 0 (0%) 0.176
Benign tumor 16 (34.7%) 13 (28.3%)
Malignant tumor 5 (10.9%) 11 (23.9%)
History of radiotherapy:
Yes 6 (13.1%) 9 (19.5%) 0.754
No 16 (34.7%) 15 (32.7%)
Type of reconstruction:
Primary 19 (41.3%) 23 (50%) 0.538
Secondary 3 (6.5%) 1 (2.2%)
Time since reconstruction to implant placement:
(Average mean in months, SD) 29.6 (SD 19.8) 26.4 (SD 14.9) 0.632
Time of usage of conventional (non implant supported) prosthesis:
(Average in months, SD) 11.4 (SD 15.3) 9.3 (SD 11.1) 0.814

radiotherapy had worse outcomes as compared to patients who did
not undergo radiotherapy in regard to the following parameters:
physical function, role function, HN pain, HN opening mouth,
functional limitation, physical disability, social disability, and
handicap. Although the severity of dysfunction and handicap
decreased after implant-based prosthetic rehabilitation, there were
poorer outcomes in patients who had undergone radiotherapy.
3.6. Post hoc power analysis
Considering that the mean SD of global health status was
47.7 17.3 in the two-implant group and 54.2 17 in the four-
implant group, with 5% level and 80% power, the needed sample
size was 107 in each group. However the current study had a
sample size of 26 each with inadequate power (32%).
4. Discussion
Although it is well accepted that rehabilitation of oral functions
is an important additional goal in the successful treatment of pa-
tients who have undergone mandibular reconstruction, the use of
implants for dental rehabilitation in this patient population is still
not universally accepted. Implant-based rehabilitation of oral
functions in patients with a reconstructed mandible is expensive
and clinically challenging (Kumar et al., 2015a,b). The lack of
evidence-based guidelines is a hindrance to the universal applica-
tion of this treatment modality. There have been many cross-
sectional as well as longitudinal studies of QoL issues following
free ap reconstruction after maxillectomy/mandibulectomy
(Bozec et al., 2008; Villaret et al., 2008; Hartl et al., 2009). However,
there have been only a few studies comparing QoL outcomes after
implant-based rehabilitation, and most of them are retrospective in
nature. When taking into consideration the rare prospective
studies, the numbers of patients with implant-supported prosthe-
ses in these studies have been too low to allow meaningful com-
parison of data (Garrett et al., 1998; Garrett et al., 2006; Dholam
et al., 2011).
Implant-based prosthetic options that may be used in patients
with a reconstructed mandible include sealed or screwed bridges,
resin-bonded bridges, tooled bars, implant-borne dentures, or
implant-supported overdentures (Raoul et al., 2009; Kleis et al.,
2010). Among these, implant-supported overdentures with a ball
abutment is not only the least expensive option but also a highly
advantageous one. This technique is especially useful in patients

Please cite this article in press as: Kumar VV, et al., Implant supported dental rehabilitation following segmental mandibular reconstruction-
quality of life outcomes of a prospective randomized trial, Journal of Cranio-Maxillo-Facial Surgery (2016), http://dx.doi.org/10.1016/
j.jcms.2016.04.013
 V.V. Kumar et al. / Journal of Cranio-Maxillo-Facial Surgery xxx (2016) 1e11 7

Table 3
Outcome measures at Time point 0 (baseline), Time point 1 (6 months following prosthesis delivery) and Time point 2 (12 months following prosthesis delivery).
(SD) Standard deviation, q1 rst quartile, q3 third quartile, Highlighted in yellow are values of statistically signicant differences between the two groups.

Parameters Time point 0 (Baseline) Time point T1 (6 month follow up) Time point T2 (12 months follow up)
2 Implant Group 4 Implant Group 2 Implant Group 4 Implant Group 2 Implant Group 4 Implant Group
Mean (SD ) / Median Mean (SD) / Median p value Mean (SD ) / Median Mean (SD) / Median p Mean (SD ) / Median Mean (SD) / Median p value
(q1, q3) (q1, q3) (q1, q3) (q1, q3) (q1, q3) (q1, q3)
Value
EORTC QLQ c-30
Global health status/QoL 47.7 (17.3) 54.1 (17.0) .144 70.1 (14.5) 71.2 (13.2) .788 75.8 (11.8) 79.9 (10.1) .210
Physical Function 82.7 (17.8) 89.7 (13.6) .107 89.4 (14.5) 90.6 (14.4) .787 95.8 (7.6) 96.1 (6.5) .865
Role Function 65.9 (28.9) 68.8 (25.2) .866 88.6 (10.8) 86.1 (16.8) .551 93.2 (11.1) 91.0, 11.0) .501
Emotional Function 54.2 (22.9, 66.7) 41.7 (8.3, 64.6) .218 83.3 (66.7, 100.0) 66.7 (52.1, 83.3) .004 90.2 (14.0) 85.8 (11.4) .248
Cognitive Function 83.3 (62.5, 83.3) 66.7 (50.0, 83.3) .286 87.9 (10.5) 80.6 (18.2) .106 88.6 (11.9) 88.9 (9.4) .937
Social Function 66.7 (45.8, 83.3) 66.7 (16.7, 66.7) .194 81.8 (19.9) 65.3 (26.4) .022 83.3 (16.3) 83.3 (13.0) 1.000
Fatigue 50.0 (19.4, 58.3) 16.7 (0.0, 44.4) .037 22.2 (0.0, 33.3) 22.2 (0.0, 33.3) 1.000 11.1 (0.0, 22.2) 5.6 (0.0, 22.2) .430
Nausea / vomiting 8.3 (0.0, 37.5) 0.0 (0.0, 16.7) .489 0.0 (0.0, 16.7) 0.0 (0.0, 16.7) .914 0.0 (0.0, 4.2) 0.0 (0.0,0.0) .939
Pain 41.7 (16.7, 70.8) 33.3 (16.7, 62.5) .504 25.0 (0.0, 33.3) 25.0 (16.7, 45.8) .295 0.0 (0.0, 16.7) 8.3 (0.0, 16.7) .771
Dyspnoea 0.0 (0.0, 33.3) 0.0 (0.0, 33.3) .921 0.0 (0.0, 8.3) 0.0 (0.0, 33.3) .656 0.0 (0.0, 0.0) 0.0 (0.0, 0.0) .451
Insomnia 33.3 (0.0, 75.0) 33.3 (0.0, 66.7) .749 0.0 (0.0, 33.3) 0.0 (0.0, 33.3) .707 0.0 (0.0,33.3) 0.0 (0.0, 33.3) .923
Appetite loss 33.3 (0.0, 75.0) 33.3 (0.0, 66.7) .749 0.0 (0.0, 33.3) 0.0 (0.0, 33.3) .707 0.0 (0.0, 33.3) 0.0 (0.0, 33.3) .923
Constipation 0.0 (0.0, 33.3) 0.0 (0.0, 0.0) .259 0.0 (0.0, 0.0) 0.0 (0.0, 0.0) .545 0.0 (0.0, 0.0) 0.0 (0.0, 0.0) .636
Diarrhoea 0.0 (0.0, 0.0) 0.0 (0.0, 0.0_ .498 0.0 (0.0, 0.0) 0.0 (0.0, 0.0) .283 0.0 (0.0, 0.0) 0.0 (0.0, 0.0) .714
Financial problems 66.7 (33.3, 66.7) 66.7 (33.3, 100.0) .651 66.7 (33.3, 66.7) 66.7 (33.3, 66.7) .825 50.0 (33.3, 66.7) 33.3 (33.3, 66.7) .943
EORTC HN 35
HN Pain 50.0 (31.3, 66.7) 33.3 (25.0, 58.3) .240 20.8 (14.6, 33.3) 25.0 (16.7, 33.3) .451 12.5 (0.0,25.0) 8.3 (0.0, 25.0) .752
HN Swallowing 33.3 (14.6, 66.7) 50.0 (4.2, 58.3) .664 8.3 (0.0, 25.0) 8.3 (0.0, 14.6) .474 8.3 (0.0, 20.8) 0.0 (0.0, 8.3) .206
HN Senses 33.3 (0.0, 50.0) 41.7 (16.7, 62.5) .459 8.3 (0.0, 33.3) 0.0 (0.0, 16.7) .548 0.0 (0.0, 16.7) 0.0 (0.0, 16.7) .779
HN Speech 55.6 (22.2, 69.4) 44.4 (22.2, 66.7) .764 11.1 (0.0, 33.3) 16.7 (0.0, 33.3) .302 5.6 (0.0, 22.2) 11.1 (0.0, 11,1) .961
HN Social eating 66.7 (39.6, 91.7) 75.0 (29.2, 91.7) .698 20.8 (8.3, 33.3) 16.7 (8.3, 47.9) .600 8.3 (0.0, 25.0) 8.3 (0.0, 16.7) .559
HN Social contact 63.3 (20.0, 81.7) 53.3 (33.3, 91.7) .294 10.0 (0.0, 26.7) 25.8 (3.3, 50.0) .056 3.3 (0.0, 17.5) 16.7 (0.0, 20.0) .080
HN Sexuality 66.7 (29.2, 66.7) 50.0 (33.3, 83.3) .832 25.0 (0.0, 33.3) 8.3 (0.0, 33.3) .677 16.7 (0.0, 33.3) 0.0 (0.0, 33.3) .742
HN Teeth 66.7 (58.3, 100.0) 100.0 (66.7, 100.0) .241 16.7 (0.0, 33.3) 33.3 (8.3, 66.7) .023 0.0 (0.0, 33.3) 0.0 (0.0, 33.3) .768
HN Opening mouth 66.7 (25.0, 100.0) 33.3 (0.0, 100.0) .253 33.3 (0.0, 33.3) 33.3 (0.0, 66.7) .981 0.0 (0.0, 33.3) 0.0 (0.0, 33.3) .282
HN Dry mouth 33.3 (0.0, 66.7) 16.7 (0.0, 58.3) .262 0.0 (0.0, 33.3) 0.0 (0.0, 33.3) .730 0.0 (0.0, 8.3) 0.0 (0.0, 0.0) .348
HN Sticky saliva 16.7 (0.0, 66.7) 0.0 (0.0, 33.3) .224 0.0 (0.0, 33.3) 0.0 (0.0, 33.3) .447 0.0 (0.0, 33.3) 0.0 (0.0, 33.3) .297
HN Coughed 33.3 (0.0, 66.7) 0.0 (0.0, 33.3) .440 0.0 (0.0, 33.3) 16.7 (0.0, 33.3) .373 0.0 (0.0, 33.3) 0.0 (0.0, 33.3) .855
HN Felt ill 33.3 (25.0, 66.7) 33.3 (0.0, 66.7) .267 0.0 (0.0, 33.3) 33.3 (0.0, 33.3) .019 0.0 (0.0, 0.0) 0.0 (0.0, 33.3) .070
HN Pain killers 100.0 (0.0, 100.0) 100.0 (0.0, 100.0) .689 0.0 (0.0, 33.3) 0.0 (0.0, 100.0) .544 0.0 (0.0, 100) 0.0 (0.0, 0.0) .301
HN Nutritional supp. 100.0 (0.0, 100.0) 0.0 (0.0, 0.0) .029 0.0 (0.0, 100) 0.0 (0.0, 0.0) .343 0.0 (0.0,50.0) 0.0 (0.0, 0.0) .176
HN Feeding tube 0.0 (0.0,0.0) 0.0 (0.0, 0.0) 1.000 0.0 (0.0, 0.0) 0.0 (0.0, 0.0) 1.000 0.0 (0.0, 0.0) 0.0 (0.0, 0.0) 1.000
HN Weight loss 100.0 (0.0, 100.0) 0.0 (0.0, 100.0) .374 0.0 (0.0, 0.0) 0.0 (0.0, 0.0) .607 0.0 (0.0, 0.0) 0.0 (0.0, 0.0) .975
HN Weight gain 0.0 (0.0,0.0) 0.0 (0.0, 0.0) 1.000 0.0 (0.0, 100) 0.0 (0.0, 0.0) .389 0.0 (0.0, 0.0) 0.0 (0.0, 0.0) .602

OHIP
functional_limitation1 3.2 (0.9) 4.0 (3.0, 4.0) .858 1.0 (1.0, 2.0) 1.0 (0.0, 2.0) .427 1.0 (1.0, 1.0) 1.0 (0.0, 2.0) .701
functional_limitation2 2.3 (1.1) 2.0 (0.0, 3.0) .220 1.5 (0.0, 2.0) 1.0 (0.0, 2.0) .132 1.0 (0.0, 2.0) 1.0 (0.0, 1.0) .079
physical_ pain1 3.0 (1.75, 3.25) 2.0 (1.0, 3.0) .337 1.0 (1.0, 2.0) 2.0 (1.0, 2.0) .227 1.0 (0.0, 1.5) 1.0 (0.0, 2.0) .821
physical_ pain2 3.0 (1.0) 3.4 (0.8) .125 1.0 (0.8,2.0) 2.0 (1.0, 2.0) .527 1.0 (0.0, 1.0) 1.0 (0.0, 2.0) .453
psychological_discomfort1 1.0 (0.0, 2.3) 1.0 (1.0, 2.0) .875 1.0 (0.0, 1.5) 1.0 (1.0, 1.0) .749
3.2 (1.0) 3.4 (0.8) .480
psychological_discomfort2 1.0 (0.8,2.0) 1.0 (0.0, 2.0) .846 1.0 (0.0, 2.0) 1.0 (0.0, 1.0) .830
3.4 (0.7) 3.1 (1.1) .306
physical_disbility1 3.1 (1.3) 2.9 (1.1) .637 1.0 (0.0, 2.0) 1.0 (0.0, 2.0) .137 1.0 (0.0, 1.0) 1.0 (0.0, 1.0) .552
physical_disability2 2.8 (0.9) 3.0 (1.2) .476 1.0 (0.0, 1.0) 1.0 (0.3, 2.8) .110 1.0 (0.0, 1.0) 1.0 (0.0, 1.0) .590
psychological_disability1 3.0 (1.0) 3.0 (1.3) .905 1.0 (1.0, 1.0) 1.0 (1.0, 2.0) .143 1.0 (0.0, 1.0) 1.0 (0.0, 2.0) .099
psychological_disability2 2.8 (1.0) 3.0 (1.1) .401 1.0 (0.0, 2.0) 1.0 (1.0, 2.0) .238 1.0 (0.0, 1.0) 1.0 (0.0, 1.0) .565
social_disability1 2.5 (1.1) 3.0 (2.0, 3.0) .608 1.0 (0.0, 2.0) 1.0 (0.0, 2.0) .471 1.0 (0.0, 1.0) 1.0 (0.0, 1.0) .496
social_disability2 3.0 (1.0, 3.0) 2.0 (1.3, 3.0) .991 0.5 (0.0, 1.0) 1.0 (0.0, 1.0) 1.000 1.0 (0.0, 1.0) 0.0 (0.0, 1.0) .053
handicap1 2.8 (1.0) 3.0 (2.0, 3.0) .433 1.0 (1.0, 2.0) 1.0 (0.3, 2.8) .891 1.0 (0.5, 1.5) 1.0 (0.0, 2.0) .960
handicap2 2.0 (0.0,3.0) 2.0 (1.0, 3.0) .562 0.50 (0.0, 1.0) 1.0 (0.0, 2.0) .283 0.0 (0.0, 1.0) 0.0, (0.0, 1.0) .329
DSI 0.0 (0.0, 3.0) 1.0 (0.0, 3.0) .674 6.5 (1.4) 6.7 (1.5) .561 7.0 (1.362) 7.3 (1.3) .561

with limited mouth opening after resection, as the implants can be
placed in accessible areas, which in turn support an overdenture.
The advantages also include the low forces transmitted to implants,
the lesser number of implants needed to stabilize the prosthesis,
and the ease in cleaning of abutments. Postoperative mucosal ex-
amination is easier to perform with removable overdentures, as this
assumes increased signicance especially in cases of oral cancer
follow-up. Economic affordability is a major factor for the majority
of patients seeking treatment, especially in a country such as India
where there is no public health insurance coverage for treatment
(Pramesh et al., 2009). Hence we chose this standardized treatment
modality for all patients in the study.
Implant-supported removable overdentures are only possible if
the peri-implant tissues have been managed adequately. In the
presence of mobile, unattached, denture-bearing mucosa and
insufcient vestibular space, it is not possible to provide a

Please cite this article in press as: Kumar VV, et al., Implant supported dental rehabilitation following segmental mandibular reconstruction-
quality of life outcomes of a prospective randomized trial, Journal of Cranio-Maxillo-Facial Surgery (2016), http://dx.doi.org/10.1016/
j.jcms.2016.04.013
8 V.V. Kumar et al. / Journal of Cranio-Maxillo-Facial Surgery xxx (2016) 1e11

Table 4
Table showing the outcome measures at dened points of time T0, T1 and T2 irrespective of the treatment group. Time point 0 Reconstructed patients with conventional
(non-implant supported) dental prosthesis, Time point 1 6 months following loading of implants (2- or 4- implant supported removable overdentures). Time point 2 12
months following loading of implants (2- or 4-implant supported overdentures). Values of statistical signicance have been highlighted.

functional removable prosthesis. The QoL values may not remain
stable and would likely deteriorate if peri-implant tissues were not
well managed, leading to peri-implant disease. Hence, soft tissue
management and a close maintenance regimen are important
factors in the rehabilitative treatment of these patients. The soft
tissue corrective technique most commonly followed in this study
has been vestibuloplasty with subperiosteal dissection and den-
ture guided epithelial regeneration (Kumar et al., 2015a,b).
The results of the study show that in patients with mandible
reconstructed with free bula ap, there were no signicant dif-
ferences in the QoL and DSI outcomes when either two or four
implants were used to support a removable partial overdenture. It
was also clearly seen that implant-supported removable over-
dentures signicantly improved QoL and DSI when compared to
conventional (non-implant-supported) prostheses. Because radio-
therapy as a treatment modality has been reported to have a
considerable inuence on QoL, additional subgroup analysis was

Please cite this article in press as: Kumar VV, et al., Implant supported dental rehabilitation following segmental mandibular reconstruction-
quality of life outcomes of a prospective randomized trial, Journal of Cranio-Maxillo-Facial Surgery (2016), http://dx.doi.org/10.1016/
j.jcms.2016.04.013
 V.V. Kumar et al. / Journal of Cranio-Maxillo-Facial Surgery xxx (2016) 1e11 9

Table 5
Table comparing outcome measures of patients with and without radiotherapy at dened points of time T0, T1 and T2.

Please cite this article in press as: Kumar VV, et al., Implant supported dental rehabilitation following segmental mandibular reconstruction-
quality of life outcomes of a prospective randomized trial, Journal of Cranio-Maxillo-Facial Surgery (2016), http://dx.doi.org/10.1016/
j.jcms.2016.04.013
10 V.V. Kumar et al. / Journal of Cranio-Maxillo-Facial Surgery xxx (2016) 1e11
conducted and revealed that patients with radiotherapy had poorer
outcomes in relation to eight of the 48 domains evaluated: physical
function, role function, HN pain, HN mouth opening, functional
limitation, physical disability, social disability, and handicap.
However, few important factors must be considered before
generalizing the results of this study in the general patient popu-
lation. Patients with reconstructed mandibles have varying char-
acteristics in terms of bony and soft tissue involvement. Stringent
inclusion and exclusion criteria were applied in choosing patients
for this study. Hence, patients with involvement of the condyle
were excluded from the study. Similarly, only patients with mini-
mal soft tissue involvement were chosen for the study. This
included patients with involvement of only the gingiva, oor of the
mouth, and gingivo-buccal and labial sulcus and excluded patients
with tongue, palate, skin, and pharyngeal defects. Another differ-
ence in patient population for the study was that the patients
enrolled in this study were much younger (mean age 35.5 years, SD
12.5 years) than the populations reported in similar studies. Hence
application of the results of this study to a different population
must be made with caution.
A shortcoming of this study is the short post-rehabilitation
follow-up time (12 months at T2). Previous studies have shown
that the outcome of questionnaires about QoL and oral functioning
and patient satisfaction remained stable between 1 and 5 years
after prosthetic rehabilitation (Korfage et al., 2010; Korfage et al.,
2011). Hence, the results of this study could have implications
that could potentially last for more than the short period of study.
Another weakness of the study is the use of OHIP questionnaires for
patients who do not understand English. Although validated ver-
sions of EORTC QLQ and H&N versions are available in Hindi, Tamil,
Malayalam, and Kannada (Indian languages), there is no validated
version of the OHIP questionnaire in these languages. Patients who
do not understand English rely on the translations provided by the
evaluator, which have not been validated prior to the study. In spite
of this handicap, meaningful studies using translated versions of
OHIP have been previously carried out in Indian rural regions
(Acharya, 2008; Keeppanasserril et al., 2001; Jain et al., 2012).
5. Conclusion
However, in spite of the drawbacks, it can be concluded that
implant-supported removable overdentures signicantly improve
denture satisfaction as well as the general and OHRQoL outcomes in
patients with reconstructed mandibles. There was no difference in
denture satisfaction and HRQoL outcomes in patients with two- or
four-implant supported removable prostheses.
Trial Registration
The trial is registered with the Clinical Trial Registry of India
number: CTRI/2012/07/002764.
Funding
This study was supported by a grant from the ITI Foundation for
the Promotion of Implantology, Grant No. SG_788_2011.
Competing interests
All authors declare: This study was supported by a grant from
the ITI Foundation for the Promotion of Implantology, Grant No.
SG_788_2011.
Acknowledgments
Dr. Vijay Pillai, Dr. Naveen Hedne, Dr. Sachin Chavare, Consul-
tants, Head and Neck Center; Narayana Health, Bangalore.
Please cite this article in press as: Kumar VV, et al., Implant supported dental rehabilitation following segmental mandibular reconstruction-
quality of life outcomes of a prospective randomized trial, Journal of Cranio-Maxillo-Facial Surgery (2016), http://dx.doi.org/10.1016/
j.jcms.2016.04.013
Dr. Sunder Raj Ellur, (Bangalore, India); Dr. Anjan Shah (Banga-
lore, India), Dr. Sunil Bhandari, (Kolkatta, India) and Dr. Anoop
Grover, (Haryana, India) for referral of patients for the study.
Dr. Ullash Kumar, Dr. Gaurav Khemeria, resident prosthodontists
of M R Ambedkar Dental College & Hospitals for prosthetic man-
agement of patients.
Dr. Vinotha P. (St. Johns Hospital, Bangalore) for statistical
analysis.
Mrs. Anjana Balakrishnan for editing and grammar corrrections.
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