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

NCT07666529 | Not Yet Recruiting

• 2 other identifiers: APHP251243N° IDRCB : 2025-A02621-48
• Study Type: interventional
• Target: 140
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Type 2 Diabetes

Keywords

Diabetes Mellitus; Type 2; Dental Implants; Mastication

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c (%) from baseline (randomization) to 9 months post-randomization.

  Biological tests such as HbA1c will be carried out in a community laboratory or in one of the hospitals affiliated with a participating research center. Physicians (diabetologists) from these centers will provide the necessary prescriptions for these tests.

  9 months

Secondary Outcomes (15)

• Change in masticatory efficiency assessed by two-colour chewing gum mixing test (Variance of Hue) from randomization to 9 months post-randomization.

  9 months

• Subjective masticatory efficiency : Change in Chewing Function Questionnaire (CFQ) total score from randomization to 9 months post-randomization.

  9 months

• Change in weight, from randomization to 9 months post-randomization.

  9 months

• Change in body mass index from randomization to 9 months post-randomization.

  9 months

• Change in triglycerides from randomization to 9 months post-randomization.

  9 months

Study Arms (2)

Replacement of one pair of molars

EXPERIMENTAL

Replacement of one pair of molars with implant-supported prostheses in addition to standard care for the management of type 2 diabetes (T2D)

Procedure: Replacement of one pair of molars

Standard care

NO INTERVENTION

Standard care for the management of type 2 diabetes only.

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.

Replacement of one pair of molars

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Central Study Contacts

Martin BIOSSE-DUPLAN, DDS, Phd

CONTACT

+33 1 53 11 18 00; martin.biosse-duplan@aphp.fr

Louis Potier, MD, PHD

CONTACT

+33 1 40 25 88 42; louis.potier@aphp.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 8, 2026
• First Posted: June 24, 2026
• Study Start (Estimated): November 15, 2026
• Primary Completion (Estimated): August 15, 2030
• Study Completion (Estimated): August 15, 2030
• Last Updated: June 24, 2026

Record last verified: 2026-04