NCT07666529Not yet recruiting
Effect of Molar Replacement on Glycemic Control in Adults With Uncontrolled Type 2 Diabetes
Source: ClinicalTrials.gov · Last updated 24 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- First submitted
- 8 Jun 2026
- Start date
- 15 Nov 2026
- Primary completion date
- 15 Aug 2030
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Diseases
- Type 2 diabetes
- NCT number
- NCT07666529
What you commit to
- Study type: Interventional
- Planned participants: 140
- From 15 Nov 2026 to the primary completion date, 15 Aug 2030
- No sites listed in no country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study design.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Participation in another interventional study involving human participants or being within the exclusion period following a previous study involving human participants, where applicable
Other illness
- Recent diabetes (\< 6 months), intensified insulin therapy (≥ 3 injections/day) or insulin pump use
- Type 1 diabetes
- 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
- Allergy to anesthetics or antibiotics required for dental surgery
Lab values
- Type 2 diabetes with HbA1c \> 10.5%
Other
- 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
- Pregnant or breastfeeding woman
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to 75 years · Sex: All · Does not accept healthy volunteers
This page is information, not medical advice. Discuss any trial with your doctor.