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Prosthetic complications in an implant-retained mandibular overdenture population: Initial analysis of a prospective study

Nancy R. Chaffee, DDS, MS,a David A. Felton, DDS, MS,b Lyndon F. Cooper, DDS, PhD,c Ulf Palmqvist, DDS,d and Rex Smith, DMDe School of Dentistry, University of North Carolina, Chapel Hill, N.C. Statement of problem. The clinical success of implant-retained, tissue-supported mandibular overdenture prostheses has been documented. However, few studies have evaluated the return visits and associated cost required to maintain these prostheses. Purpose. The purpose of this investigation was to evaluate the amount of maintenance required to provide acceptable and satisfactory implant-retained mandibular overdentures in a prospective clinical trial. Material and methods. Fifty-eight patients received new maxillary and mandibular complete dentures followed by placement of microthreaded/TiOBlast implants in the mandibular left and right canine regions. At 3 months, ball abutments were placed, and the mandibular prostheses were relined to receive Dalla Bonatype ball housings (baseline). Prostheses were prospectively evaluated, and adjustments were made at 3-, 6-, 12-, 24-, and 36-month recall visits and at nonscheduled visits for 9 types of prosthetic complications. Results. Of 58 patients, 6 required no adjustments. The remaining 52 patients made 327 return visits (including 194 nonscheduled visits) for prosthesis and/or abutment adjustments. One hundred and fifteen practitioner hours were required to provide prosthetic solutions to patient concerns at the return visits. The total estimated cost for all professional and laboratory services was $12,624.00 ($218.00 per patient). Conclusion. Although mandibular implant-supported overdentures with Dalla Bonatype ball attachments are an acceptable treatment option for edentulous patients, routine maintenance is required to ensure successful long-term outcomes. (J Prosthet Dent 2002;87:40-4.)

CLINICAL IMPLICATIONS
Mandibular implant-supported overdentures are an acceptable treatment option for edentulous patients but require routine maintenance. Biologic adaptation to the prosthesis is patient specific.

he introduction of endosseous dental implants has greatly improved treatment modalities for the edentulous mandible, for which implant success rates greater than 95% have been reported.1 The success of dental implants has been measured by various investigators in terms of established consensus criteria.2 Prosthodontic and loading issues were first recognized as valid outcome measures of success by Albrektsson and Zarb.3 Prosthetic outcomes may be influenced by the type of prosthesis used to restore the edentulous mandible. Currently, controversy exists concerning the relative merits of fixed detachable prostheses versus overdenture prostheses. This is particularly evident with regard
This research was funded by a grant from Astra Tech AB, Molndal, Sweden. aAssistant Professor, Department of Prosthodontics. bAssociate Professor and Chair, Department of Prosthodontics. cAssociate Professor, Department of Prosthodontics. dDirector, Clinical Research, Astra Tech AB, Molndal, Sweden. eClinical Director, Astra Tech Inc, Lexington, Mass. 40 THE JOURNAL OF PROSTHETIC DENTISTRY

to maintenance, complications, and longevity.4-8 Multiple clinical studies have reported that overdenture prostheses for the edentulous mandible have a good prognosis in terms of implant survival.9-15 However, the amount of maintenance required to ensure long-term clinical success continues to be a concern.4-8,10,13 Hemmings et al4 compared 50 patients who took part in 2 separate studies: 25 patients were treated with implant-retained fixed prostheses in one study, and 23 patients from a second study plus 2 patients from the first study were treated with overdenture prostheses retained with an implant-supported bar-clip mechanism. The authors reported that postinsertion adjustments were more common for overdenture prostheses during the first year. They also found that overdenture prostheses presented fewer maintenance requirements and complications than fixed prostheses over 5 years. Walton and MacEntee5 compared the time and costs of making and maintaining implant prostheses in a private prosthodontic practice. Of the 69 prostheses
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fabricated, 49 were fixed and the remaining 20 were removable. Of the removable prostheses, 85% were retained by a bar-clip mechanism. The authors reported that removable prostheses required 4 times as many adjustments as fixed prostheses over an average of 22 months. Removable prostheses most commonly required contour adjustments for comfort and repair or replacement of the retentive components. In a prospective 3-year study, Davis and Packer16 evaluated 25 patients with implant-supported overdentures retained by either magnet attachments (12 patients) or 2-piece stud/ball attachments (13 patients). The authors reported that the magnet- and stud-retained prostheses required 64 and 63 episodes of postplacement care, respectively, with no significant difference between the groups. Forty-six percent of these episodes occurred during the first year for the magnet group and 54% for the stud/ball group. The most frequent adjustment reported was tightening of the 2-piece stud/ball portion of the attachment mechanism. The purpose of the present investigation was to evaluate the amount of maintenance required to provide acceptable and satisfactory implant-retained mandibular overdentures in an ongoing, 60-month prospective clinical trial. This article reports data from the first 36 months.

Table I. Inclusion and exclusion criteria used for patient selection


Inclusion criteria Completely edentulous Aged 35-75 years Good physical and mental health Willing to give informed consent Sufficient bone of good quality and quantity to support implants at least 11 mm in length Exclusion criteria Uncontrolled diabetes History or presence of disease that may negatively influence treatment Known alcohol and/or drug abuse Clinical or radiographic signs of pathologic processes of the mandible History of recurrent apthous ulceration or other recurrent mucosal irritation Extreme maxillomandibular skeletal discrepancies (severe Angles Class II or Class III) Bruxism

MATERIAL AND METHODS


Subjects were selected for the clinical trial with the strict inclusion and exclusion criteria reported by Cooper et al17 (Table I). Fifty-eight edentulous patients were treated. New maxillary and mandibular complete dentures were fabricated with custom impression trays and elastomeric final impressions. Maxillomandibular relationship records were obtained with the use of stabilized record bases with occlusion rims. An esthetic tooth evaluation was completed to obtain patient approval and establish a balanced lingualized occlusal scheme with anterior (Portrait IPN; Dentsply Trubyte, Dentsply International Inc, York, Pa.) and posterior prosthetic teeth (Myerson Lingualized Integrated; Austenal, Myerson Division, Chicago, Ill.). The dentures were inserted, and the patients were seen for postoperative adjustments. Each mandibular denture was duplicated in clear acrylic resin (Orthodontic Resin; Caulk/Dentsply) to provide a tomographic/surgical guide for implant placement. A 1-stage surgical technique was used to place microthreaded/TiOBlast implants (Astra Tech AB, Molndal, Sweden) in the mandibular right and left canine regions. Healing abutments were placed at the time of surgery, and the denture was relieved and inserted immediately after surgery. After 3 months, the healing abutments were removed, ball abutments were placed, and the
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mandibular prosthesis was relined to receive Dalla Bonatype ball housings. A closed-mouth, completearch technique was utilized in which the impression copings for the ball abutments were picked up in the impression. Upon placement of the relined prosthesis, baseline measurements were taken. Subsequent evaluations were made at 3, 6, 12, 24, and 36 months as well as at nonscheduled visits for prosthetic complications. All prosthetic complications were tabulated through chart review by a single investigator.

RESULTS
Fifty-eight (100%) patients in the trial completed the 12-month evaluation, 38 (65%) the 24-month evaluation, and 13 (22%) the 36-month evaluation. Six (10%) of the 58 patients required no adjustments, but 52 (90%) required 327 return visits for prosthesis/abutment adjustments and repairs/remakes. Of the 327 return visits, 194 (59.3%) were nonscheduled. Denture adjustments. Twenty-three patients required no adjustments. Thirty-five patients required 85 visits for the adjustment of denture sore spots/ulcerations, which accounted for 26.0% of all complications. The mean number of adjustments per patient was 1.49 (SD=1.92; range 0 to 9 adjustments). The mean time from baseline to first adjustment was 89.5 days (SD=297.17 days; range 2 days to 37.7 months). Ball housing complications. Thirty-five patients required 88 visits for the adjustment of inadequately retentive ball housings, which accounted for 26.9% of all complications. The mean time from
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Table II. Treatment times and laboratory/component costs


Procedure Chairtime (min) Laboratory cost (US$) Component cost (US$) Total cost (US$)

Adjust denture Adjust ball housing Replace ball housings

15 15 60

0 0 85

Replace abutments Tighten ball housings

10 60

0 85

Tighten abutments Repair teeth Repair denture base Reline

15 15 15 60

0 25 25 85

Remake denture

180

(four 45-min visits)

102

0 0 45 12 15 116 45 12 15 0 0 0 45 12 15 45 1 15

(Housing) (Impression coping) (Replica) (Housing) (Impression coping) (Replica)

0 0 229

(2 Housings)

116 229

(1 Abutment) (2 Housings)

(Housing) (Impression coping) (Replica) (Housing) (Impression coping) (Replica)

0 25 25 229

(2 Housings)

246

(1 Denture)

baseline to first adjustment was 9.86 months (range 1 day to 38 months). The mean number of adjustments was 2.51 per patient (SD=1.72). Three patients lost a ball housing from their dentures, and 7 patients reported loose ball housings within the denture base; both complications required reprocessing in the laboratory. One patient reported loosening of the ball housing on 3 separate occasions. Prosthetic tooth complications. Thirteen patients required 27 visits to replace broken/debonded anterior and posterior prosthetic teeth, which accounted for 9.1% of all complications. The mean number of tooth repairs per patient was 0.44 (SD=1.81). One patient was responsible for 14 of these return visits. The location of the debonded teeth was not associated with the location of the ball housings. The mean number of days from denture placement to repair was 98.79 (SD=234.81, range 27 to 1100 days). Relines and repairs of mandibular overdentures. Eighteen patients required 20 mandibular relines, with a mean of 0.34 relines per patient. The mean time until the first reline was 16.49 months (SD=10.73, range 8 to 966 days). Four patients required 12 mandibular denture base repairs. The mean time until the first repair was 35.66 days (SD=171.86, range 93 to 1123 days). Repairs were most frequently required for mandibular midline fractures. Relines and repairs of maxillary conventional dentures. Sixteen patients required 18 maxillary prosthesis relines, with a mean of 0.31 relines per patient. The mean time until the first reline was 16.86 months (SD=11.93, range 34 to 969 days). No repairs were required for maxillary conventional dentures.
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Abutment complications. Six abutments required tightening in 3 patients. The mean time until required tightening was 22.78 days (SD=120.7, range 1 to 1140 days). Abutment replacement was required for 2 patients. One patient fractured an abutment 9 separate times in the mandibular left canine region; the other patient required replacement of an abutment due to surrounding tissue overgrowth. Miscellaneous complications. During the initial 36 months of the study, new dentures were required for 2 patients because of improper fit of the original prostheses and for 1 patient who lost his maxillary denture. One patient was diagnosed and treated for squamous cell carcinoma in the mandible, and another patient died due to complications from emphysema. Time and cost. The 327 return visits were estimated to have required 115 practitioner hours (clinic time) for resolution of patient concerns (Table II). The estimated cost for the laboratory services and implant components over 327 return visits was $12,624.00, or $218.00 per patient. The unexpected loss of dentures accounted for $738.00 in laboratory services/implant components and 12 appointments.

DISCUSSION
In this investigation, patients were treated with a 1-stage surgical technique after denture fabrication with traditional prosthodontic techniques. While 10% of the patients required no adjustments, 52 patients required a total of 297 visits, 65% of which were nonscheduled. The number of nonscheduled recall visits could present a challenge in a private practice setting. More than half of these visits, however, were for sore spot/ulceration adjustment or ball
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housing tightening; neither is a time-consuming or costly procedure. The fact that 13 patients required replacement of broken/debonded teeth is also a concern. Of the 27 visits devoted to this complication, 14 were by one patient. Apparently, residual wax on the prosthetic teeth was not appropriately removed during processing. Such problems can be prevented if proper laboratory techniques are utilized. Sixteen patients required 18 maxillary prosthesis relines to improve the stability and retention of their maxillary dentures. A similar finding was reported previously for implant patients with mandibular dentures, regardless of whether they were fixed or removable.18 Patients generally seek improved stability and retention of the maxillary denture after accommodating to a highly retentive implant-retained mandibular prosthesis. Eighteen patients required 20 relines of their mandibular implant-retained prostheses. The necessity for laboratory reline was assessed by anteroposterior rotation about the interabutment axis. Laboratory relines were performed when gingival displacement at the second molar was estimated to be 1 mm, when clinical evidence of altered occlusal relationships was found, or when patient complaints of overdenture instability were recorded. Given the absence of objective criteria for relining implant-supported overdentures, the primary objectives of limiting extensive rotation about the interabutment axis and maintaining well-distributed contacts between the intaglio surface of the denture and the mucosa were met by careful clinical assessment of overdenture rotation, stability, and occlusion at each recall visit. Posterior bone loss under the denture-bearing area will be assessed at the 60-month recall appointment via panoramic radiographs. Only 6 abutments required tightening in 3 patients. This finding is much lower than that reported by Davis and Packer.16 The discrepancy can be explained by the fact that the 2-piece abutment that they used was redesigned by the manufacturer into the 1-piece abutment used in this investigation to prevent loosening and/or breakage of the ball attachment. Although 1 patient fractured an abutment on 9 separate occasions, this complication does not appear to be common. Three patients required new maxillary dentures, 1 due to loss and 2 due to poor esthetics/fit. This may be indicative of the patient population. Since the patients in this study did not pay for their treatment, they may not have recognized the financial repercussions of carelessness or ineffective communication with the practitioner. Required remakes added $738 to the total cost of care. It may be argued that this additional need for treatment should not be considered in an analysis of adjustments and repairs. An estimated 115 practitioner hours were required
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to resolve patient concerns. This equals 0.99 hours per prosthesis, which is less than the 1.52 hours per removable prosthesis but greater than the 0.54 hours per fixed prosthesis reported by Walton and MacEntee.6 Estimates of treatment time and economic impact for the various complications are provided in Table II. Treatment times and costs vary by clinician/geographic region; these figures are provided only for comparative purposes.

CONCLUSIONS
Under the conditions of this study, the following conclusions were drawn: 1. The initial results of this study suggest that mandibular implant-supported overdentures with Dalla Bonatype ball attachments are an acceptable treatment option for edentulous patients but require routine maintenance. 2. Prosthetic components may be less reliable than implant components; great care in denture fabrication is needed to match the manufacturers quality assurance. 3. The most common prosthodontic complications reported in this study required denture base adjustments and tightening of the ball housing attachment mechanism. Relines of maxillary complete dentures and mandibular overdentures were required most commonly after 16 months of service. 4. Biologic adaptation to removable prostheses, whether conventional or implant-retained, is patient specific.
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mucosal aspects of ITI implants supporting overdentures. A five-year longitudinal study. Clin Oral Implants Res 1994;5:9-18. Watson RM, Jemt T, Chai J, Harnett J, Heath MR, Hutton JE, et al. Prosthodontic treatment, patient response, and the need for maintenance of complete implant-supported overdentures: an appraisal of 5 years of prospective study. Int J Prosthodont 1997;10:345-54. Ekfeldt A, Johansson LA, Isaksson S. Implant-supported overdenture therapy: a retrospective study. Int J Prosthodont 1997;10:336-74. Zarb GA, Schmitt A. The edentulous predicament. II: The longitudinal effectiveness of implant-supported overdentures. J Am Dent Assoc 1996;127:66-72. Davis DM, Packer ME. Mandibular overdentures stabilized by Astra Tech implants with either ball attachments or magnets: 5-year results. Int J Prosthodont 1999;12:222-9. Cooper LF, Scurria MS, Lang LA, Guckes AD, Moriarty JD, Felton DA. Treatment of edentulism using Astra Tech implants and ball abutments to retain mandibular overdentures. Int J Oral Maxillofac Implants 1999;14:646-53. Narhi TO, Geertman ME, Hevinga M, Abdo H, Kalk W. Changes in the edentulous maxilla in persons wearing implant-retained mandibular overdentures. J Prosthet Dent 2000;84:43-9.

Reprint requests to: DR NANCY R. CHAFFEE DEPARTMENT OF PROSTHODONTICS 404 BRAUER HALL, CB 7450 UNC SCHOOL OF DENTISTRY CHAPEL HILL, NC 27599-7450 FAX: (919)966-3821 E-MAIL: nchaffee@earthlink.net Copyright 2002 by The Editorial Council of The Journal of Prosthetic Dentistry. 0022-3913/2002/$35.00 + 0. 10/1/121486

doi:10.1067/mpr.2002.121486

Noteworthy Abstracts of the Current Literature

Immediate postextraction implant placement with rootanalog stepped implants: Surgical procedure and statistical outcome after 6 years. Gomez-Roman G, Kruppenbacher M, Weber H, Schulte W. Int J Oral Maxillofac Implants 2001;16:503-13.

Purpose. The Frialit-2 dental implant system has been available since 1990. The implant system uses 2 different designs, a stepped screw and a stepped cylinder, to prevent atrophy of the alveolus through placement of the anatomic implant soon after tooth loss. This study presented 6-year results of the clinical use of this implant system. Material and methods. Frialit-2 implants were placed in the maxilla and mandibles of patients who presented to the Department of Oral Surgery and Periodontology at the Dental School of the University of Tubingen (Germany). Inclusion and exclusion criteria were applied. Implant diameter and length were left to the discretion of the treating surgeon. Study parameters included plaque index, gingival index, probing depth, Periotest values, and peri-implant bone loss. Statistical analysis was performed with the Kaplan-Meier method. Results. A total of 124 stepped-screw implants were placed in the jaws of 104 patients. The average observation time was 2.6 years with a maximum period of 6.3 years. Two implants were lost because of instability and radiolucency. Kaplan-Meier analysis demonstrated a 97% survival rate. Conclusion. Implant survival in this study suggests that the Frialit-2 implant is well suited for immediate placement after tooth loss. 45 References.SE Eckert

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