The primary purpose of this study will be to determine whether an overlay mandibular denture supported by osseointegrated dental implants is an effective treatment alternative to a conventional complete denture in diabetic patients whose metabolic biochemical control is achieved primarily either by dietary therapy, which may be supplemented by oral hypoglycemic agents, or by insulin. The effectiveness of the two types of dentures would be based upon improvements in denture comfort, masticatory efficiency, food selection, dietary intake, quality of life, patient satisfaction and cost of initial and maintenance care. One hundred and eight elderly male diabetic patients with acceptable metabolic control will be randomly assigned to four groups providing two control groups, one with 24 insulin treated (IT) and the other with 24 non-insulin treated (NIT) patients and two experimental groups, one with 30 IT and the other with 30 NIT patients. Patients in the control groups will receive a new set of maxillary and mandibular dentures and in the experimental groups a new maxillary denture and an overlay mandibular denture supported by two osseointegrated implants. They will be followed in the Diabetic Clinic on a quarterly basis for glycosylated hemoglobin concentrations and in the Dental Clinic for observation and oral hygiene instructions. In addition, they will be instructed to monitor their fasting glucose levels at least three times a week. A series of clinical evaluations and subjective and objective measurements will be made immediately after entry into the study and at 6-month and 36-month intervals after the insertion of new dentures. Three sets of questionnaires (food preference, patient treatment evaluation and patient satisfaction) will be administered to determine perceived changes in mastication, speech, odor, denture hygiene, comfort, security and psychological well-being. The objective measurements will include salivary secretion rates, tactile discrimination thresholds, maximal biting pressures, oral clearance tests, and masticatory performance tests, electromyographic activity and mandibular movement recordings. A one-week dietary log will be kept to determine changes in food consumption patterns in terms of the degree of difficulty to chew foods. Comparisons between the two treatment groups will be made on the differences in percentages of treatment failures based on prespecified criteria as well as differences in the mean scores for each of the subjective and objective variables.

Agency
National Institute of Health (NIH)
Institute
National Institute of Dental & Craniofacial Research (NIDCR)
Type
Research Project (R01)
Project #
1R01DE009085-01A1
Application #
3222878
Study Section
Oral Biology and Medicine Subcommittee 1 (OBM)
Project Start
1990-03-01
Project End
1995-02-28
Budget Start
1990-03-01
Budget End
1991-02-28
Support Year
1
Fiscal Year
1990
Total Cost
Indirect Cost
Name
University of California Los Angeles
Department
Type
Schools of Dentistry
DUNS #
119132785
City
Los Angeles
State
CA
Country
United States
Zip Code
90095
Kimoto, Katsuhiko; Garrett, Neal R (2005) Effect of mandibular ridge height on patients' perceptions with mandibular conventional and implant-assisted overdentures. Int J Oral Maxillofac Implants 20:762-8
Roumanas, Eleni D; Garrett, Neal R; Hamada, Michael O et al. (2003) Comparisons of chewing difficulty of consumed foods with mandibular conventional dentures and implant-supported overdentures in diabetic denture wearers. Int J Prosthodont 16:609-15
Roumanas, Eleni D; Garrett, Neal R; Hamada, Michael O et al. (2002) A randomized clinical trial comparing the efficacy of mandibular implant-supported overdentures and conventional dentures in diabetic patients. Part V: food preference comparisons. J Prosthet Dent 87:62-73
Friedlander, Arthur H; Garrett, Neal R; Norman, Dean C (2002) The prevalence of calcified carotid artery atheromas on the panoramic radiographs of patients with type 2 diabetes mellitus. J Am Dent Assoc 133:1516-23
Hamada, M O; Garrett, N R; Roumanas, E D et al. (2001) A randomized clinical trial comparing the efficacy of mandibular implant-supported overdentures and conventional dentures in diabetic patients. Part IV: Comparisons of dietary intake. J Prosthet Dent 85:53-60
Kapur, K K; Garrett, N R; Hamada, M O et al. (1999) Randomized clinical trial comparing the efficacy of mandibular implant-supported overdentures and conventional dentures in diabetic patients. Part III: comparisons of patient satisfaction. J Prosthet Dent 82:416-27
Kapur, K K; Garrett, N R; Hamada, M O et al. (1998) A randomized clinical trial comparing the efficacy of mandibular implant-supported overdentures and conventional dentures in diabetic patients. Part I: Methodology and clinical outcomes. J Prosthet Dent 79:555-69
Garrett, N R; Kapur, K K; Hamada, M O et al. (1998) A randomized clinical trial comparing the efficacy of mandibular implant-supported overdentures and conventional dentures in diabetic patients. Part II. Comparisons of masticatory performance. J Prosthet Dent 79:632-40