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journal of dentistry 39 (2011) 871–877

Available online at www.sciencedirect.com

journal homepage: www.intl.elsevierhealth.com/journals/jden

Pilot study of unidirectional E-glass fibre-reinforced


composite resin splints: Up to 4.5-year clinical follow-up

Ovul Kumbuloglu a, Ahmet Saracoglu a, Mutlu Özcan b,*


a
Department of Prosthodontics, Ege University, School of Dentistry, Izmir, Turkey
b
Dental Materials Unit, University of Zürich, Center for Dental and Oral Medicine, Clinic for Fixed and Removable Prosthodontics and
Dental Materials Science, Plattenstrasse 11, CH-8032 Zurich, Switzerland

article info abstract

Article history: Objectives: This prospective clinical pilot study evaluated the performance of fibre-rein-
Received 17 May 2011 forced-composite resin (FRC) splints on mandibular anterior teeth.
Received in revised form Methods: Between June-2003 and January-2008, 19 patients (7 females, 12 males, 45–72 years
19 September 2011 old) from a group of consecutive patients who completed periodontal therapy received
Accepted 27 September 2011 E-glass FRC splints (everStick Perio, StickTech) in combination with two types of flowable
and restorative resin-composites (Filtek Flow, Filtek Supreme, n = 11; Tetric Flow, Tetric-
Ceram, n = 8). Only patients with vital teeth, presenting mobility of grade 3, having at least
Keywords: one canine with no mobility on both sides of the dental arch were assigned for a splint
Fibre-reinforced composite therapy. The patients were recalled for periodical follow-up controls first at 6 months and
Periodontal splint thereafter annually. The evaluation protocol involved technical failures [chipping, debond-
Clinical follow-up ing or fracture (tooth/restoration)] and biological failures (caries)]. Periodontal pocket depth
(PPD) and clinical attachment level (CAL) were measured 6 months after splinting and
annually. Six sites were measured for each natural tooth at the mesiobuccal, buccal,
distobuccal, distolingual, lingual and mesiolingual sites.
Results: All splints were applied from canine to canine in the mandible. In total, 5 recalls
were performed and no drop-out was experienced. One partial debonding of the FRC splint
with Tetric Flow/Tetric-Ceram combination was observed after 40 months. No caries was
found around any of the splints and no teeth had to be extracted until the final follow up.
The splinted teeth were found to be vital in the vitality tests. Overall survival rate was 94.8%
(Kaplan–Meier). The survival rate was not significantly affected by the composite type
(Filtek-Flow/Filtek Supreme: 100%, Tetric Flow/Tetric Ceram: 96% ( p = 0.92) [Kaplan–Meier,
Log Rank (Mantel–Cox) (CI = 95%)]. Hazard ratio for Tetric Flow/Tetric Ceram group was 0.05
(95% CI) and for Filtek Flow/Filtek Supreme group 0.00 (95% CI). Whilst overall PPD measure-
ments of the dentition ranged between 6 and 12 mm, the CAL measurements ranged
between 4.9 and 10 mm at baseline. The mean PPD for the splinted teeth decreased from
8.9  1.8 mm to 5.2  1.2 mm, and CAL decreased from 7.2  1.6 mm to 4.6  1 mm at the
end point.
Conclusion: Direct tooth splinting with E-glass FRC material performed successfully up to 4.5
years. Periodontal status of the splinted teeth showed decreased PPD and CAL.
# 2011 Elsevier Ltd. All rights reserved.

* Corresponding author. Tel.: +41 44 63 45600; fax: +41 44 63 44305.


E-mail address: mutluozcan@hotmail.com (M. Özcan).
0300-5712/$ – see front matter # 2011 Elsevier Ltd. All rights reserved.
doi:10.1016/j.jdent.2011.09.012
872 journal of dentistry 39 (2011) 871–877

solely rely on adhesion of the flowable composite or the resin


1. Introduction matrix of the FRC to the etched and bonded enamel. Pre-
impregnated FRC systems usually involve monomers such as
Teeth are splinted and stabilized in the anterior or posterior urethane dimethacrylate (UDMA), urethane tetramethacrylate
regions of the mouth for a variety of reasons. Clinical (UTMA), bisphenol glycidylmethacrylate (Bis-GMA) or poly-
situations that require tooth stabilization include mainly methylmethacrylate (PMMA).15 Evidence still lacks whether
orthodontic retention,1–3 repositioning or re-implantation of ultra high molecular weight polyethylene (UHMWPE) fibres
the avulsed teeth that were subjected to trauma,4 splinting could be used to fabricate durable FRC restorations.16 Criticism
teeth in primary or secondary occlusal trauma, and periodon- has been focused on the inadequate interfacial adhesion
tal splinting of the severe mobile teeth after elimination of the between polyethylene fibres and dental polymers, compared
periodontal disease.5,6 However, not every mobile tooth to glass fibres that can be silanized.17
should be splinted and the duration for splinting could be Development of silanized and resin-impregnated, FRC
short-term or long-term depending on the situation.6 For materials has provided the potential new approaches for
splint applications, biological and biomechanical principles stabilizing hypermobile teeth or replacing teeth in a conser-
should be considered in a multidisciplinary approach.6 vative manner.14 Unfortunately, no long-term clinical study is
The main objectives of splinting teeth in patients with available to date with such FRCs used for splinting pur-
advanced periodontal problems are to achieve periodontal poses.18,19 Therefore, this pilot study evaluated the clinical
healing, create an oral environment in which tooth mobility is performance of FRC splints on the anterior mandibular teeth
at a tolerable level or at least no longer increasing and the in the periodontal treated patients.
patient is able to function comfortably.7 Often such patients
avoid chewing on or incising food with such mobile teeth,
yielding to soft diet restrictions. 2. Materials and methods
Splints in dentistry are classified as provisional or perma-
nent and they may be either fixed or removable.8 They may be 2.1. Patient population
constructed of various materials being as simple as a bonded
composite resin button connecting one tooth to the other In this prospective clinical study, between June 2003 and
allowing better cleanability of the teeth. Yet, this type of January 2008, 19 patients (7 females, 12 males, minimum age:
stabilization is considered transient in nature, due to the 45, maximum: 72 years old) received FRC splints at the Ege
inability of composite resin to accommodate shear forces.9 University, Dental School, Department of Prosthodontics,
Several clinical studies in the field of orthodontics reported Izmir, Turkey, after signing the appropriate informed consent
high debonding rates when the mandibular or maxillary teeth form approved by the Ethical Committee of the University
are splinted with the use of metal wires.1–3 Although the Institutional Review Board (vote number of the local Ethical
reason for these failures are not well studied, several factors Committee No.: 7OM/743). The subjects were not admitted to
are described in the dental literature such as insufficient the study if any of the following criteria were present: (1)
composite material6 and/or abrasion of the composite,10,11 younger than 18 years old, (2) not able to read and sign the
less abrasion resistance and wear as a consequence of informed consent document, (3) physically and psychologi-
chewing or tooth-brushing,10,11 thickness of the wire12 and cally not normal, (4) having general health-compromising
intermittent forces of mastication.10,11 Another reason for conditions, (5) pregnant or had a history of ectopic pregnancy,
debonding rates was attributed to the forces resulting from (6) undergoing active periodontal and/or orthodontic therapy,
tension in the wire or between the wire and the teeth when the (7) an impaired response to infection, (8) using tooth whitening
wire has not been adapted properly to the surface of the dentifrices, (9) smokers, (10) missing teeth in the splinting
teeth.10 Nevertheless, detachment of the bonded wire retai- area, (11) history of endodontic therapy and/or any restoration
ners may have negative consequences for the treatment on the teeth to be evaluated, (12) residence outside the city
result, possibly making re-treatment necessary.12 In fact, teeth where the study was conducted, insufficient address for
without mobility are splinted in orthodontics after the end of follow-up, or unwillingness to return for follow-up as outlined
the orthodontic treatment to avoid relapse response of the by the investigators.
teeth to their original positions, whereas in peridontally All restorations were made directly by one operator using
compromised patients, usually splinting is achieved on mobile unidirectional E-glass fibres (everStick Perio, StickTech) in
teeth at various grades. In that respect, theoretically, resin- combination with two types of flowable and resin composites
impregnated fibre-reinforced-composite resin (FRC) materials (Filtek Flow, Filtek Supreme, 3M ESPE, n = 11; Tetric Flow,
are well suited for stabilizing hyper-mobile teeth that interfere Tetric Ceram, Ivoclar Vivadent, n = 8). The resin composite
with chewing function because of their elastic modulus, materials were standard materials of the clinic and they were
aesthetics, pliability, and the possibility of chemical adhesion applied based on the availability of the system in our clinics.
both to the composite materials and the tooth, as opposed to Materials used for this study are listed in Table 1.
the metal wires.13 From a group of consecutive patients, those who had
Resin pre-impregnated FRCs has suitable flexural modulus undergone periodontal therapy with root planning and scaling
and flexural strength to function successfully in the mouth as procedures followed by clinical follow-up controls on a
restorative materials.14,15 It is considered that elimination of periodical basis and reached a stable hygiene phase, have
the metal wire in the retainer by using FRC systems would lead been selected. All clinical periodontal status measurements
to more stable bonding since adhesion of such retainers would were performed by an experienced periodontist. All patients
journal of dentistry 39 (2011) 871–877 873

Table 1 – The brand names, compositions, manufacturers and batch numbers of the main materials used in this study.
Brand name Composition Manufacturera Batch number
1
everStick Perio E-glass/PMMA/Bis-GMA StickTech Ltd., Turku, Finland 000088
Heliobond1 Monomer matrix: dimethacrylate, Ivoclar Vivadent, Schaan, Liechtenstein H29583
<60% Bis-GMA, <40% triethyleneglycol 154518
Tetric Flow1 <14% Bis-GMA, <8% triethylene Ivoclar Vivadent, Schaan, Liechtenstein J01476
glycoldimethacrylate, 154518
<15% urethanedimethacrylate
Tetric Ceram Dimethacrylate-based monomers Ivoclar Vivadent, Schaan, Liechtenstein J10519
(17–18% weight), barium glass, J04092
ytterbium trifluoride, mixed oxide and
prepolymer containing fillers
(82–83% weight), additives, catalysts,
stabilizers and pigments (<1.0% weight)
Adper Single Bond Plus Bis-GMA, HEMA, dimethacrylates, 3M ESPE, St. Paul, MN, USA 7KM
ethanol, water, photoinitiator system,
methacrylate functional copolymer of
polyacrylic and polyitaconic acids,
5 nm silica particles
Filtek Supreme Bis-GMA, Bis-PMA, TEGDMA, UDMA, 3M ESPE, St. Paul, MN, USA 8RB
silica and zirconia nanofiller
Filtek 250 Bis-GMA, Bis-EMA, UDMA, silica and 3M ESPE, Minnesota, St. Paul, MN, USA 6ST
zirconia particles
a
Information according to each manufacturer’s material safety sheet data (everStick Perio, StickTech Ltd., 20.05.2008, Nr. 100002; Heliobond,
Ivoclar Vivadent, 27.09.2007, Nr. 1142; Tetric Flow, Ivoclar Vivadent, 01.10.2007, Nr. 1667; Tetric Ceram, Ivoclar Vivadent: 07.07.2011, Nr. 1907/
2006/EC; Adper Single Bond Plus, 3M ESPE, 30.03.2004, Nr. 18-9025-0; Filtek Supreme, 3M ESPE, 02.11.2004, Nr. 18-0179-4).

were using manual toothbrush, were able to practice the use of material was placed in the bed of the flowable resin with the
dental floss and interdental brushes at the stabilized hygiene aid of a silicone mould available in the FRC kit (Silicone Refix,
phase. In the selected group of patients, splinting was Stick Tech, Finland). The silicone mould with the FRC material
indicated due to severe mobility and lack of chewing comfort in its groove in the middle was exerted onto the lingual surface
reported by the patients, at the Periodontology Department of of the tooth on the flowable resin with gentle pressure. In the
the Dental School. Only patients with vital teeth, presenting cases where the tooth was lingually positioned in relation to
mobility of grade 3 and having at least one canine with no the neighbouring teeth, the silicone mould was pressed not
mobility on both sides of the dental arch were assigned for a only on the lingual but also at the approximal sites to achieve
splint therapy. continuous alignment of the FRC. FRC together with the
flowable composite was photo-polymerized for 40 s per tooth
2.2. Splinting procedure surface. Whilst polymerization on each tooth, the rest of the
silicone mould was protected from the polymerization device
After providing informed consent, the teeth on the labial and with a metal hand instrument. When the whole FRC was
lingual surfaces were cleaned with pumice using a prophylaxy polymerized, the silicone mould was removed and the
brush on a slow-speed hand-piece at 3000 rpm. All splints exposed surfaces of the FRC were covered by the same
were made under rubber-dam. In order to avoid excess of flowable composite and photo-polymerized again for 40 s.
adhesive resin or resin composite, orthodontic elastic bands All FRC splints were made with one bundle of FRC material,
(Wedjets, Coltène/Whaledent AG, Altstätten, Switzerland) their surfaces were completely covered with resin composite
were placed at the interdental spaces between the teeth to and each layer was again photo-polymerized for 40 s from all
be splinted after placing the rubber-dam. With small amounts aspects. Finally, after occlusal adjustments, all FRC splints
of resin composite (FiltekTM Z250, 3M ESPE), all mobile teeth were finished using fine diamond burs (model number 012;
were temporarily attached to each other at their labial Intensiv, Grancia, Switzerland) to remove the excess resin
surfaces and photo-polymerized (Demetron LC, SDS Kerr, composite. Subsequently, the composite surfaces were
Orange, CA, USA; light intensity: 600 mW/cm2) for 10 s. The polished with coarse, medium, fine, and ultrafine finishing
purpose of this step was to stabilize the mobile teeth and to disks (Sof-Lex, 3M ESPE) in sequence using with a hand-piece
avoid any displacement during splinting. For this process, the at 3000 r.p.m. in order not to expose fibres.
enamel surfaces were not etched and no surface preparations Oral hygiene protocols, the use of interdental brushes and
were made. flosses were practised once more and the patients were
Enamel surfaces on the palatal side were then etched with recalled for periodical follow-up controls first at 6 months and
37% orthophosphoric acid for 60 s. After rinsing with water thereafter annually. Periodontal health, tooth mobility, level
and air-drying, the corresponding intermediate adhesive resin of oral hygiene and the condition of FRC splint in all patients
was applied onto the surfaces using a microbrush, gently air- were assessed during the follow-up controls according to the
dried and photo-polymerized for 20 s. A thin layer of flowable written protocol. Patients were informed about possible
composite resin was applied on the enamel surfaces and left complications and instructed to call upon experience of a
unpolymerized. Then, previously measured length of FRC failure that could occur until the actual annual follow-up
874 journal of dentistry 39 (2011) 871–877

appointment. The evaluation protocol involved technical (Mantel–Cox) (CI = 95%)]. Hazard ratio for Tetric Flow/Tetric
failures [chipping, debonding or fracture (tooth/restoration)] Ceram group was 0.05 (95% CI) and for Filtek Flow/Filtek
and biological failures (caries)]. On the periodontal aspect, Supreme group 0.00 (95% CI).
periodontal pocket depth (PPD) and clinical attachment level No caries was found around any of the splints, no teeth had
(CAL) were measured 6 months after splinting and thereafter to be extracted until the final follow up. The splinted teeth
annually. Six sites were measured for each natural tooth, one were found to be vital in the vitality tests. Patient compliance
each at the mesiobuccal, buccal, distobuccal, distolingual, and satisfaction was very high.
lingual and mesiolingual sites encircling the tooth. Clinical The overall PPD measurements of the dentition ranged
attachment level refers to the distance between the cement– between 6 and 12 mm at baseline (Fig. 2). The mean PPD for the
enamel junction and the base of the sulcus. splinted six mandibular teeth was 8.9  1.8 mm at baseline
and at final control of the splint treatment it was decreased to
2.3. Statistical analysis 5.2  1.2 mm. The CAL measurements for the overall dentition
ranged between 4.9 and 10 mm at baseline (Fig. 2). CAL also
Survival time was calculated starting from the date of FRC decreased for the splinted teeth from 7.2  1.6 mm to
splint placement to the end of the follow-up period. Survival 4.6  1 mm at the end point (Fig. 3).
analyses were performed with statistical software program
(SPSS 13.0; SPSS Inc., Chicago, IL, USA) using Kaplan–Meier and
Log Rank (Mantel–Cox) tests at a significance level of 0.05 to 4. Discussion
evaluate results versus time.
Except one incidence that was repaired using the silica coating
and silanization method and remained functional during the
3. Results observation period, the results of this study were very
promising with both flowable and resin composites in
All splints were applied from canine to canine in the mandible. combination with the FRC system employed. Most probably
In total, 5 recalls were performed and no drop-out was etching enamel and adhesive application was sufficient to
experienced. One partial debonding of the FRC splint in the achieve good adhesion of the flowable resin and thereby the
group with Tetric Flow/Tetric-Ceram combination was ob- whole FRC splint. Hence, both flowable and resin composite
served after 40 months. It was repaired using the CoJet system combinations used could be suggested for periodontal splint-
(3M ESPE) with Filtek Supreme composite and remained ing. Today, repair actions using surface conditioning methods
functional until the final observation date. Life-tables calcu- and resin composites prolong the survival of resin-based
lated from the data and Kaplan–Meier curves revealed an restorations.20 Therefore, restorations that remain functional
overall survival rate of 94.8% after 4.5-year observation time for many years after repair procedures cannot be considered
(Fig. 1). The survival rate was not significantly affected by the as catastrophical failures.
composite type (Filtek-Flow/Filtek Supreme: 100%, Tetric Dental literature contains information on FRC splint
Flow/Tetric Ceram: 96% (p = .92) [Kaplan–Meier, Log Rank construction in case reports but longitudinal studies are

Fig. 1 – Event-free cumulative percentage of FRC splints depending on the composite type (Filtek Supreme vs. Tetric Ceram).
Hazard ratio: 0.05 (95% CI), for Tetric Flow/Tetric Ceram group (n = 8, events n = 1, censored n = 0); hazard ratio: 0.00 (95% CI),
for Filtek Flow/Filtek Supreme group (n = 11, events n = 0, censored n = 0).
journal of dentistry 39 (2011) 871–877 875

Fig. 2 – Mean values (mm) of periodontal pocket depth (PPD) and clinical attachment level (CAL) of six sites (mesiobuccal,
buccal, distobuccal, distolingual, lingual and mesiolingual sites) of six mandibular natural tooth (n = 36 sites per patient)
measured in 19 patients, 6 months after splinting (baseline), 18, 30, 42 and 54 months.

limited or they report only short-term results.18,19 One such Since this study was not conducted in a larger population of
study presented 1-year follow-up of functional rehabilitation patients, it could be considered as a pilot study. The patients
of a patient with severely advanced, rapidly progressing retrieved for this study did not always have at least one canine
marginal bone loss treated by using the same FRC material with no mobility one one side of the mandible or did not report
used in this study. However, periodontal findings were only any chewing discomfort after after periodontal therapy which
descriptive.18 In another clinical study, periodontal outcome resulted in exclusion of many patients resulting in less
of stabilized mobile teeth with an E-glass fibre (Fibre-Kor) was number of patient enrolment. One tooth support with no
assessed. In that study, 56 patients were enrolled which is mobility was amongst the selection criteria in order to provide
higher than that of this study. The study presented the results a stable construction. The lack of mechanical failures in the
only after 10 months where PPD decreased by an average of group of Filtek-Flow/Filtek Supreme, and occurrence of no
0.58 mm after teeth stabilization. PPD decrease in this study caries did not make it possible to calculate the power and
between 6 months and 18 months observations was an consider multifactorial statistical design. Future studies on
average of 1.2 mm. Additional information is needed whether larger populations should verify the results of this study with
this is due to the limited number of patients in this study or the the use of the studied resin composites in conjunction with
difference in FRC materials used. the FRCs.
The thickness of the FRC-flowable resin complex may
affect the longevity of the splints. From the mechanical point
of view, FRC reinforced splints should be evaluated differently
than those of bridge constructions. Static compression tests
demonstrated that with the increasing fibre content, the
flexural strength increases linearly.21 Such information is
often derived from bar shaped specimens prepared according
to the ISO norms where usually 2 mm of veneering composite
was placed on the FRC material. Considering the geometry of
the periodontal splints clinically, this thickness may not be
favourable due to the added thickness of the splint, which may
lead to plaque accumulation or disturbance with the occlu-
sion. Since the construction should not exceed 2 mm, the FRC
could even weaken the fibre/composite complex. The required
thickness of the fibre–composite complex could be reached
when box or groove preparations are made in the lingual
Fig. 3 – Mean and standard deviations of periodontal pocket surfaces. However, this would then not fit in the minimal
depth (PPD) (n = 684 at each timepoint) and clinical invasive treatment approach. For this reason, in this study, no
attachment level (CAL) (n = 684 at each timepoint) mechanical retentions or preparation were made on the
measurements from 6 teeth at 6 sites in 19 patients, 6 enamel surfaces. In clinical practice, the complete thickness of
months after splinting and thereafter annually. the whole complex in a splint could still be considered high.
876 journal of dentistry 39 (2011) 871–877

The dilemma however remains how to control the thickness of up to 4.5 years. Periodontal status of the splinted teeth also
the bonded retainers clinically. In this study, the thickness of showed decreased periodontal pocket depth and clinical
the flowable composite covering the FRC splint was controlled attachment level.
manually. Whether the thickness of the composite impairs the
survival of the splints needs to be analysed. Failed splints need
to be evaluated also from this aspect in the future.
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