A randomized clinical trial comparing the efficacy of mandibular implant-supported overdentures and conventional dentures in diabetic patients. Part IV: Comparisons of dietary intake.

STATEMENT OF PROBLEM: It is unclear whether the replacement of conventional mandibular dentures with implant-supported overdentures alters the diet and thus improves the nutritional intake of edentulous persons. PURPOSE: The purpose of this study was to compare the pretreatment and posttreatment diets of edentulous diabetic patients who received new dentures with either a conventional complete mandibular denture (CD) or a mandibular implant-supported overdenture (IOD). MATERIAL AND METHODS: New dentures were made for 89 edentulous diabetic patients with acceptable metabolic control without insulin (NIT) or with insulin (IT). A randomized approach was used to assign 37 patients a mandibular CD and 52 patients a mandibular IOD supported by 2 cylindrical implants. Of the 89 patients, 58 submitted a dietary log for 7 consecutive days before treatment (PT) and 6 months after treatment completion (PTC). An average daily intake of 28 essential nutrients was determined for each patient at each time interval. Separate 2 x 2 x 2 repeated analysis of variance (ANOVA) tests were performed for each nutrient to compare the means of the 2 denture groups (CD and IOD), 2 diabetic groups (NIT and IT), and 2 time intervals (PT and PTC). The intakes were also compared with the recommended daily allowance (RDA). RESULTS: ANOVAs for all 28 nutritional variables showed no main effect for either denture type or diabetic treatment. Time effects were seen for magnesium, potassium, copper, and monounsaturated fats. The PTC mean intake of the total sample (N = 58) decreased for all 3 minerals and increased for monounsaturated fats with study dentures. Post hoc tests showed the differences between PT and PTC means to be statistically significant for only magnesium (P=.043) and potassium (P=.015). The percentage of patients with PT intake 25% or more below the RDA ranged from 33% to 85% in the CD group and from 24% to 100% in the IOD group for the same 11 nutrients. PTC fiber intake deficiency was noted in almost all participants. Carbohydrate consumption was markedly lower than that recommended by the American Diabetic Association. CONCLUSION: As is often the case with elderly groups, this group of edentulous diabetic patients showed highly comprised nutritional intakes of fiber, vitamins, and minerals. The replacement of old dentures with new dentures that included either a mandibular CD or IOD did not alter patient diets such that the patients improved their nutritional intakes of essential micronutrients and macronutrients.

Randomized clinical trial comparing the efficacy of mandibular implant-supported overdentures and conventional dentures in diabetic patients. Part III: comparisons of patient satisfaction.

STATEMENT OF PROBLEM: There is insufficient evidence to indicate the functional superiority of mandibular implant-supported overdentures to justify their use in edentulous patients. PURPOSE: This study compared the benefits perceived by patients who received a new maxillary denture and a mandibular conventional denture (CD) and an implant-supported overdenture (IOD). METHOD: New maxillary and mandibular dentures were delivered to 89 diabetic denture wearers with clinically acceptable metabolic control who treated their diabetes either with insulin (IT) or without insulin (NIT). Of the 89 patients, 37 received maxillary and mandibular CDs and 52 received a maxillary CD and an IOD. Two questionnaires with categorical responses were used; the first contained 13 questions to ascertain a patient's absolute assessments of original dentures at entry and study dentures at 6- and 24-months after treatment completion; the second questionnaire had 11 questions that assessed the relative change perceived by patients with study dentures. Of the 78 patients who completed the posttreatment (PT) assessments at 6 months, 68 patients provided longitudinal data for questionnaire I and cross-sectional data for questionnaire II. In addition, 46 patients (18 CD and 28 IOD) also provided PT assessments at 24 months. RESULTS: Both mean scores and percentage distributions of longitudinal data for questionnaire I showed perceptual improvements with both types of study dentures. Improvements were higher in the IOD than in the CD group. Mean scores failed to show any significant differences between the 2 treatment groups. The only significant difference was found in the change in percentage distributions for perceptual chewing ability in favor of the IOD group. Even this advantage was lost at 24 months. With the comparative questionnaire, a higher percentage of patients in the IOD group than in the CD group perceived improvements with study dentures from their original dentures in chewing ability, chewing comfort, and denture security. However, mean differences were statistically significant in favor of the IOD group only for chewing ability and less difficulty to chew hard foods. CONCLUSION: The mandibular implant-supported overdenture offers same advantage in terms of perceived chewing function over the conventional denture.

Functional criteria for mandibular implant placement post resection and reconstruction for cancer.

STATEMENT OF PROBLEM: Osseointegrated implants used in the mandible post resection and reconstruction for cancer represents a treatment option with the potential for functional improvement and enhanced quality of life. Unfortunately, protocols for their use in this patient population have been empirical and technique-driven with the assumption that they will overcome most, if not all, functional deficits encountered. PURPOSE: The article reviews the salient oral physiologic factors for this group of patients and presents a rational approach and functional criteria for patient selection and implant placement. Other considerations discussed include: timing of implant placement, irradiated and compromised tissues, patient motivation, and tumor prognosis. CONCLUSION: These principles, if followed, may enhance realistic functional outcomes for this patient population.

A randomized clinical trial comparing the efficacy of mandibular implant-supported overdentures and conventional dentures in diabetic patients. Part II. Comparisons of masticatory performance.

STATEMENT OF PROBLEM: Convincing evidence is lacking to demonstrate the functional superiority of mandibular implant-supported overdentures over conventional dentures. PURPOSE: This randomized clinical trial was conducted to compare masticatory functional effectiveness of mandibular implant-supported overdentures and conventional dentures in diabetic denture wearers with clinically acceptable metabolic control. METHODS: A total of 102 edentulous diabetic patients, treated with or without insulin, were randomized to receive a new maxillary and either a mandibular conventional denture or an implant-supported overdenture. Treatment was completed in 89 patients, 37 with conventional dentures and 52 with Hader bar-clip attachment overdentures supported by two IMZ implants. Besides data from medical and dental histories, oromaxillofacial examinations, and questionnaires, masticatory tests were performed by patients before and at 6 and 24 months after treatment completion. Although 78 patients (28 in the conventional, 50 in the overdenture group) performed tests at 6 months after treatment, 68 (25 in the conventional, 43 in the overdenture) had performance data for both entry and 6-month posttreatment intervals. RESULTS: The two treatment groups were highly comparable in terms of general characteristics, quality of original dentures, tissue support, and past denture experience. No significant differences were found between patients treated for diabetes with or without insulin. All four masticatory performance scores with original dentures were higher in the conventional denture group than the overdenture group. The posttreatment performance scores for the two treatment groups became similar because of the higher gains in the overdenture group. Patients with low initial performance scores showed greater posttreatment gains with both conventional dentures and overdentures. CONCLUSIONS: The implant-supported overdenture showed no significant advantage over the conventional denture for improving the ability to comminute food in this group of diabetic patients with higher than average initial functional levels observed for other groups of denture wearers in previous studies.

Restoration of irradiated patients using osseointegrated implants: current perspectives.

STATEMENT OF PROBLEM: The success rates of osseointegrated implants used to restore patients who were irradiated for head and neck tumors are influenced by radiation-induced changes in the hard and soft tissues. PURPOSE: This article examined, by review of the literature, current perspectives on the restoration of irradiated patients using osseointegrated implants. RESULTS: In published reports that investigated both intraoral and extraoral applications, irradiation decreased implant success rates and the amount of reduction was dependent on the location within the craniofacial skeleton. The limited number of implants and patients in these studies precludes definitive conclusions regarding the efficacy of placing implants into irradiated tissues. The implants placed into the irradiated anterior mandible have demonstrated an acceptable implant success rate of 94% to 100% with a minimal risk of osteoradionecrosis. The efficacy of implants in the posterior mandible has not been examined. Implant success rates ranged from 69% to 95% in the irradiated maxilla for intraoral applications. Extraoral applications demonstrated excellent implant success rates in the temporal bone (91% to 100%). The rates in the anterior nasal floor have varied from 50% to 100%. The implant success rates in the frontal bone decreased as the length of the studies increased (96% to 33%). The long-term efficacy of implants in the irradiated frontal bone is poor.

A randomized clinical trial comparing the efficacy of mandibular implant-supported overdentures and conventional dentures in diabetic patients. Part I: Methodology and clinical outcomes.

STATEMENT OF PROBLEM: Scientific evidence is lacking to support the general application of implant-supported mandibular overdentures. PURPOSE: This randomized clinical trial was undertaken to compare the efficacy of conventional mandibular and implant-supported overdentures in diabetic edentulous patients with clinically acceptable metabolic control. METHOD: A total of 102 diabetic patients, treated with or without insulin, were randomized to receive a new maxillary denture and either a conventional or an implant-supported removable mandibular overdenture. Treatment was completed for 89 patients, 37 with the conventional and 52 with implant-supported dentures. Detailed examinations, tests, and questionnaires were given before and at 6- and 24-months after treatment completion. Comparisons between the two treatment groups were made for treatment failures based on prespecifed criteria and the type and amount of maintenance care provided. RESULTS: The insulin and noninsulin treated groups were collapsed because of the lack of significant differences at entry. The conventional denture and implant-supported overdenture groups were similar in terms of general demographics, medical status, quality of their original dentures and denture support, several functional measures, and patient satisfaction. Treatment was judged to be successful in 56.9% of patients with conventional dentures and 72.1% with overdentures. This difference in success rate was not statistically significant (p > 0.05). Patients with treatment failures in both groups required excessive maintenance care. Those with conventional dentures needed frequent denture base adjustments and relines, whereas those with overdentures required frequent clip replacements and repairs. Although significant improvements were seen with both treatment modalities, a higher percentage of patients with implant-supported overdentures than those with conventional dentures reported improvements in chewing comfort and moderate-to-complete overall satisfaction.

Osseointegrated implants and orbital defects: U.C.L.A. experience.

PURPOSE: A clinical study of 23 craniofacial implants placed in 8 irradiated and nonirradiated orbital detects was conducted over a 7-year period. MATERIAL AND METHODS: Implant-retained orbital prostheses were fabricated, implant success rate was determined, and the soft tissue responses were recorded at 6-month intervals. As a result of patient death, no data were gathered on three implants. A five-point scale was used to record the health of the peri-implant soft tissues and the patients were followed from 9 to 72 months. The unit of measure was a visit/site that was assigned for each instance an implant site was evaluated. Evaluations were conducted at 6-month intervals, and for the study period, there were 80 visit/sites. RESULTS: The study revealed that 42.5% (34/80) of the visit/sites demonstrated an absence of inflammation; 23.7% (19/80) of visit/sites demonstrated slight redness; 13.8% (11/80) demonstrated peri-implant red and moist tissues; 6.2% (5/80) demonstrated granulation tissue associated with the implants; and 13.8% (11/80) infection of the peri-implant soft tissues was noted. Implant success rate was 35% (7/20); implant success rate in the nonradiated patients was 37.5% (3/8) and the success rate for radiated patients was 33.3% (4/12). Implants placed in the orbital region demonstrated a high failure rate. Most implant failures occurred late as opposed to early in the study period. CONCLUSION: Orbital implants should be placed in patients who understand that long-term success rates may be low and require meticulous hygiene maintenance.

Prosthetic-surgical collaborations in the rehabilitation of patients with head and neck defects.

Resection of head and neck tumors often results in severe facial disfigurement and functional disabilities. Superior rehabilitation efforts rely on close collaboration between the resection surgeon, reconstructive surgeon, and the maxillofacial prosthodontist. Trauma patients are best rehabilitated surgically, whereas patients with head and neck tumors are best rehabilitated prosthetically in combination with specific surgical reconstruction procedures. This article describes these modifications. Surgical advancements such as microvascular free flaps and endosseous implants have greatly enhanced rehabilitative efforts.

Reconstructed mandibular defects: fibula free flaps and osseointegrated implants.

Twenty patients with microvascular fibula flap reconstruction of oromandibular defects were selected for implant-retained prosthodontic rehabilitation. A total of 71 osseointegrated implants were placed within the grafted fibulas. Four patients had immediate implant placement at the time of their reconstructive surgery, and the remaining 16 patients had implants placed secondarily. One patient received postoperative radiation therapy (5910 cGy) 6 weeks following reconstruction and immediate implant placement. No implants were placed in previously irradiated flaps. A minimum 6-month period of osseointegration was allowed prior to second stage surgery. Fifty-four of the 71 implants were uncovered; 46 of these implants were functional, and 3 were in the process of being restored. Among the 54 implants (15 patients) that were uncovered, only 1 failed to osseointegrate, 2 implants were reburied, and 2 were removed. The follow-up period ranged from 1 to 49 months since second stage surgery. Although a number of prosthodontic designs were used, 11 of the 15 patients were restored with removable overlay prostheses. Only those implants exposed to postoperative radiation demonstrated radiographic bone loss following functional loading.

Clinical evaluation of implants retaining edentulous maxillary obturator prostheses.

PURPOSE: Fabricating a maxillary obturator can be challenging. Placement of implants can have a dramatic effect on the stability and retention of the prosthesis in the edentulous maxillectomy patient. This article provides clinical retrospective analysis of osseointegrated implants used to retain maxillary obturators. MATERIAL AND METHODS: Patient charts and radiographs were reviewed to determine implant status, bone loss patterns, and implant survival rates. Twenty-six patients were included with 102 implants placed, from which there were 19 intact withdrawals (implants lost because of recurrent disease or patient death), five implants with unknown status, 24 implant failures, and 54 functional implants. RESULTS: The overall survival rate for implants in this patient population was 69.2%. The percent implant survival rate was 63.6% for the irradiated group (67.0% before radiation, 50.0% after radiation) and 82.6% for the nonirradiated group. Implants located in anterior sites demonstrated statistically significant differences in annual bone height changes compared with posterior sites. CONCLUSIONS: The majority of implant failures (18 of 24) occurred either at stage II surgery or before loading. Implants placed during tumor resection, implants placed within the maxillectomy defects, and implants receiving postoperative radiation demonstrated low survival rates.

Nasal defects and osseointegrated implants: UCLA experience.

A clinical study of 23 craniofacial implants placed in 11 nasal defects was conducted over a 7-year period. Implant-retained nasal prostheses were fabricated, implant success rate was determined, and the soft tissue responses were recorded at 6-month intervals. No data were gathered on two implants because of patient death. The implant success rate was 71.4% (15/21) but varied significantly by anatomic site. The implant success rate in the glabella was 0% (0/4), whereas the success rate in the anterior nasal floor was 88.1% (15/17). All implant failures occurred within the first year of loading. A five-point scale was used to record the health of the peri-implant soft tissues, and the patients were followed up from 6 to 74 months. The unit of measure was a visit/site, and a unit was assigned for each instance an implant site was evaluated. Evaluations were conducted at 6-month intervals for a total of 76 visit/sites for the study period. The results revealed that 85.5% (65/76) of the visit/sites demonstrated an absence of inflammation; 10.5% (8/76) of the visit/sites demonstrated slight redness; 1.3% (1/76) demonstrated peri-implant red and moist tissues; 2.6% (2/76) demonstrated granulation tissue associated with the implants; and 0% (0/76) demonstrated infection of the peri-implant soft tissues. Severe soft tissue reactions around implants placed in the anterior nasal floor are rare.

Surgical stents for composite mandible reconstruction.

Surgical stents have improved and simplified our ability to predictably restore maxillomandibular relationships after composite oromandibular resections. Bimaxillary relationships are optimized, the aesthetic result is enhanced, and successful dental rehabilitation follows.

Auricular prostheses and osseointegrated implants: UCLA experience.

A clinical study of 40 craniofacial implants placed in 13 auricular defects was conducted over a 6-year period. Implant-retained prostheses were fabricated, the implant success rate was determined, and the soft tissue responses were recorded at regular intervals. All of the implants became osseointegrated and none demonstrated failure during the study period. A five-point scale was used to record the health of the peri-implant soft tissues and the patients were followed up for up to 69 months. The results were as follows: 55.1% of the visit/sites demonstrated an absence of inflammation; 32.3% of the visit/sites demonstrated slight redness; 4.7% demonstrated red and moist peri-implant tissues; 5.5% demonstrated granulation tissue associated with the implants; and in 2.4% of the implants, infection of the peri-implant soft tissues was noted. Good patient hygiene compliance combined with thin and immobile peri-implant soft tissues resulted in minimal soft tissue complications.

Advances in osseointegrated implants for dental and facial rehabilitation following major head and neck surgery.

Osseointegrated implants can be used to facilitate retention stability and support for facial and intraoral prostheses used to restore head and neck defects. Preliminary studies indicate that in nonirradiated maxillectomy patients the success rates are about 75%. In the reconstructed mandible the results appear to be more favorable--over 90% for implants placed in free nonvascularized bone grafts and over 90% for free revascularized bone grafts. Similar high success rates have been observed for most sites used to support facial prostheses. Success rates for auricular sites exceed 95% and for floor of nose sites success rates exceed 90%. Success rates have been lower (77%) for implants placed in the frontal bone for retention of orbital prostheses. Success rates for irradiated bone sites have been lower and range from 60.4% in the maxilla to 68.6% in facial bone sites. Of greater concern is that most implants placed in irradiated sites are beginning to show signs of impending failure.

Restoration of oral function after maxillectomy with osseous integrated implant retained maxillary obturators.

This study assesses the success rate of osseous integrated implantation in assisting the prosthetic obturation of maxillectomy defects. Twenty-three patients received a total of 85 osseous integrated implants used for retaining maxillary obturators between 1985 and 1993. Defects include 13 radical maxillectomies, 5 premaxillary resections, 4 subtotal maxillectomies, and 1 soft-palate resection. Thirteen patients (50 implants) received a radiation dose ranging from 5,040 to 7,940 cGy. Implants can be placed at the time of ablation or subsequently. Efforts were made to spare uninvolved segments of the maxilla, especially premaxillary segments and tuberosities, at the time of ablation. Following a 6-month period of integration, implants were uncovered and utilized in prosthetic rehabilitation. Specific implant sites reveal variable success rates, with the anterior maxilla being 86% successful compared with the posterior maxilla being 57% successful. Radiation reduces the success rate from 80% to 55%, although it does not eliminate a patient from being a candidate for implantation. Prosthetic rehabilitation of large maxillary defects can be greatly facilitated with the use of osseous integrated implants in the remaining midfacial skeleton.