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

Sponsor
Assistance Publique - Hôpitaux de Paris
Study ID
NCT07666529
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Replacement of one pair of molars — PROCEDURE
    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.

Study Details

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 Dates

First listed
Jun 24, 2026
Start date
Nov 15, 2026
Status verified
Apr 2026
Primary completion
Aug 15, 2030
Completion
Aug 15, 2030

Study Design

Enrollment
140 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH

Arms

  • Experimental: Replacement of one pair of molars
    Replacement of one pair of molars with implant-supported prostheses in addition to standard care for the management of type 2 diabetes (T2D)
  • No Intervention: Standard care
    Standard care for the management of type 2 diabetes only.

Primary Outcome Measure

Change in HbA1c (%) from baseline (randomization) to 9 months post-randomization. [ Time Frame: 9 months ]

Central Contacts

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