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NCT07666529

Effect of Molar Replacement on Glycemic Control in Adults With Uncontrolled Type 2 Diabetes

Sponsor: Assistance Publique - Hôpitaux de Paris

View on ClinicalTrials.gov

Summary

Type 2 diabetes (T2D) is a major global health issue, affecting about 9.2% of adults in Europe. Although treatment begins with lifestyle changes and medications, up to half of patients fail to achieve adequate blood sugar control, highlighting the need for new strategies. People with T2D often have poorer oral health, including missing teeth and more severe periodontal disease. This reduces masticatory (chewing) efficiency, which depends largely on having functional molars. Impaired chewing can influence food choices and overall diet quality. This study explores whether improving chewing ability by replacing missing molars can help patients with uncontrolled T2D improve their diet and blood sugar levels. The hypothesis is that restoring masticatory efficiency with implant-supported prostheses will lead to healthier eating habits and better glycemic control. This study is a multicenter, randomized controlled trial with two groups: * Intervention group: receives molar replacement with implant-supported prostheses plus standard diabetes care. * Control group: receives standard diabetes care only. The main goal is to assess the effect of this intervention on glycemic control after 9 months, measured by changes in HbA1c levels. All participants will receive a comprehensive oral health assessment and necessary dental care (e.g., treatment of infections, cavities, and periodontal disease), which may itself improve quality of life and potentially support better diabetes control by reducing inflammation. For the intervention group, restoring molars is expected to improve chewing efficiency, enhance quality of life, and encourage healthier dietary habits, which could improve diabetes outcomes. Additionally, since poor chewing ability is linked to higher cardiovascular risk, the intervention may also help reduce heart disease risk.

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

140

Start Date

2026-11-15

Completion Date

2030-08-15

Last Updated

2026-06-24

Healthy Volunteers

Conditions

Type 2 Diabetes

Interventions

PROCEDURE

Replacement of one pair of molars

The intervention group will receive one or two implant-supported crowns necessary to restore a functional pair of molars in occlusion. The implant or implants placed will be made of commercially pure titanium, with a tapered cylindrical shape and dimensions (diameter and length) adapted to each clinical situation. After a minimum healing period of 3 months, fabrication of the crown(s) can begin. Once osseointegration of the implant has been confirmed, a physical or digital impression will be taken to manufacture the abutment and the implant-supported crown. The abutments and crowns will be produced using CAD/CAM technology, in titanium and ceramic respectively (milling followed by finishing). The crowns may be either cement-retained or screw-retained, depending on the clinical situation.

Inclusion Criteria: * Adults aged between 18 and 75 years * Type 2 diabetes diagnosed for more than 6 months, according to the diagnostic criteria of the International Diabetes Federation * Insufficiently controlled type 2 diabetes (HbA1c between 7.5% and 10.5%) * Type 2 diabetes under stable treatment for at least 3 months (no initiation or discontinuation of antidiabetic treatments, and no change in basal insulin dose greater than ±50% compared with the initial dose) * Presence of all teeth up to the second premolars, i.e. presence of maxillary and mandibular incisors, canines and premolars. The absence of premolars extracted for orthodontic reasons or due to agenesis is not taken into account. Teeth replaced by fixed tooth- or implant-supported prostheses are considered present. * Absence of functional molar pairs not compensated by a partial prosthesis, or presence of only one functional molar pair. The absence of a pair may be due to the absence of both molars or only one molar (molar without an antagonist). Third molars are not taken into account. Exclusion Criteria: * Recent diabetes (\< 6 months), intensified insulin therapy (≥ 3 injections/day) or insulin pump use * Type 1 diabetes * Type 2 diabetes with HbA1c \> 10.5% * Comorbidities contraindicating part of the oral rehabilitation (particularly implant placement) or impacting masticatory efficiency, such as end-stage renal disease or stroke within the past 6 months * Smoking \>10 cigarettes/day * Presence of severe crestal defects, insufficient prosthetic space, malocclusions and/or parafunctions contraindicating part of the oral rehabilitation * Severe periodontitis (Stage III or IV, Grade C) * Cancerous or precancerous lesions of the oral mucosa * Allergy to anesthetics or antibiotics required for dental surgery * Pregnant or breastfeeding woman * Participation in another interventional study involving human participants or being within the exclusion period following a previous study involving human participants, where applicable * No affiliation to a social security scheme * Patient benefiting from State Medical Aid (AME) * Individual deprived of liberty or under legal protection measures * Refusal or inability to provide written informed consent