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Type 2 DiabetesDIABETEETHNCT07666529

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

A study testing Replacement of one pair of molars in people with Type 2 Diabetes, run by Assistance Publique - Hôpitaux de Paris.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Type 2 Diabetes
What is being tested?
Replacement of one pair of molars
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
140 participants
Where
No sites listed yet
Study dates
15 Nov 2026to 15 Aug 2030
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

No sites are listed yet. Contact the study team or a site near you to ask about taking part.

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

About this study

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.
Read the detailed description

Diabetes is one of the leading causes of death and disability worldwide. The current prevalence of the most common form of diabetes, type 2 diabetes (T2D), is estimated at 9.2% among individuals aged 20-79 years in Europe. First-line management of T2D relies on therapeutic lifestyle modifications (diet and physical activity), with pharmacological treatment added in case of failure. Despite the wide range of available pharmacological options, up to 50% of individuals living with T2D who adhere to treatment do not achieve their glycemic targets. There is therefore a need to identify alternative strategies to reduce blood glucose levels.

Individuals living with T2D generally have poorer oral health than the general population, with a reduced number of teeth and more frequent and severe periodontitis. This results in lower masticatory efficiency compared with the general population, as masticatory efficiency mainly depends on the number of teeth in occlusion, particularly the presence of premolars and molars. The persistence of at least one pair of first molars plays a major role in determining the ability to grind and mix food. Masticatory efficiency influences dietary choices.

It is currently unknown whether improving masticatory efficiency in individuals with uncontrolled diabetes, through the replacement of missing teeth, modifies dietary habits and improves diabetes control. The hypothesis of this study is that, in individuals with uncontrolled T2D, restoring masticatory efficiency by replacing missing molars with fixed implant-supported prostheses will lead to improved dietary quality and better glycemic control.

This is a multicenter, open-label, two-arm parallel-group, superiority randomized controlled trial. Participants will be randomized in a 1:1 ratio to receive either:

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

Control: standard care for the management of T2D only.

The primary objective is to evaluate the impact of replacing one pair of molars with implant-supported prostheses in individuals living with uncontrolled T2D and reduced masticatory efficiency, at 9 months post-randomization, on glycemic control.

The primary endpoint is the difference in HbA1c between randomization and 9 months post-randomization.

Regarding individual benefits, all patients included in the study will benefit from a comprehensive oral health assessment allowing screening for dental caries, dental infections, periodontal disease, oral mucosal pathologies (including pre-cancerous and cancerous lesions and oral candidiasis), xerostomia, malocclusion, and temporomandibular joint disorders. These conditions are more frequent in patients with T2D. All included patients will subsequently receive dental care aimed at eliminating infectious foci and treating any carious lesions and periodontal diseases that may be present. The assessment and dental care will improve patients' oral health and contribute to a better oral health-related quality of life. They may also potentially improve diabetes control, as infectious foci and periodontal diseases are responsible for local and systemic inflammation that complicates glycemic control.

For patients included in the intervention group, restoration of a functional molar pair in occlusion is expected to significantly increase masticatory efficiency and further improve oral health-related quality of life. The intervention may also lead to changes in dietary habits toward a healthier and more balanced diet. Such dietary changes could be beneficial for diabetes control. As reduced masticatory efficiency is associated with a higher risk of coronary heart disease, the intervention may also reduce the risk of cardiovascular disease. The implants and implant-supported prostheses used to restore a molar pair are provided as part of the research.

Conditions
Type 2 Diabetes
Being tested
Replacement of one pair of molars
Keywords
Diabetes Mellitus, Type 2, Dental Implants, Mastication
Medical subject headings
Diabetes Mellitus, Type 2, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Replacement of one pair of molarsProcedure or surgery

    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 groups in NCT07666529
Study groupRoleWhat they receive
Replacement of one pair of molarsExperimentalReplacement of one pair of molars with implant-supported prostheses in addition to standard care for the management of type 2 diabetes (T2D)
Receives: Procedure: Replacement of one pair of molars
Standard careNo interventionStandard care for the management of type 2 diabetes only.

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 9 months

Secondary outcomes (15)
  1. Change in masticatory efficiency assessed by two-colour chewing gum mixing test (Variance of Hue) from randomization to 9 months post-randomization.

    Objective masticatory efficiency will be assessed using a validated two-colour chewing gum mixing test. Participants will chew a bi-coloured chewing gum for 20 chewing cycles. The chewed gum will then be flattened into a 1-mm thick wafer, scanned, and analyzed using ImageJ software. The score is based on the quantification of residual unmixed colour pigments. Lower scores indicate better colour mixing and therefore better masticatory efficiency, whereas higher scores indicate poorer masticatory efficiency.

    Measured: 9 months

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

    Subjective masticatory efficiency will be assessed using the Chewing Function Questionnaire (CFQ), a 10-item questionnaire. Each item is rated on a 5-point Likert scale ranging from 0 ("never") to 4 ("very often"). The total score is calculated as the sum of all item scores and ranges from 0 to 40. Higher scores indicate greater chewing difficulties and therefore poorer subjective masticatory efficiency, whereas lower scores indicate fewer chewing difficulties. A score of 0 indicates the absence of chewing-related problems.

    Measured: 9 months

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

    Weight are measured during visits in one of the hospitals affiliated with a participating research center.

    Measured: 9 months

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

    BMI are measured during visits in one of the hospitals affiliated with a participating research center.

    Measured: 9 months

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

    Triglycerides measures are 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.

    Measured: 9 months

  6. Change in HDL cholesterol from randomization to 9 months post-randomization.

    HDL cholesterol measures are 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.

    Measured: 9 months

  7. Change in total cholesterol from randomization to 9 months post-randomization.

    Total cholesterol measures are 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.

    Measured: 9 months

  8. Change in glucose Time in Range (TIR; 70-180 mg/dL) assessed by continuous glucose monitoring over 15 days from randomization to 9 months post-randomization.

    Glycemia is measured continuously over 15 days using a FreeStyle Libre sensor.

    Measured: 9 months

  9. HbA1c values at randomization and at 3 and 6 months post-randomization.

    HbA1c will be measured 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.

    Measured: 6 months

  10. triglyceride values at randomization and at 3 and 6 months post-randomization.

    Triglycerides will be measured 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.

    Measured: 6 months

  11. HDL cholesterol values at randomization and at 3 and 6 months post-randomization.

    HDL cholesterol will be measured 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.

    Measured: 6 months

  12. Total cholesterol values at randomization and at 3 and 6 months post-randomization.

    Total cholesterol will be measured 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.

    Measured: 6 months

  13. Mean cost of replacing one functional molar pair with implant-supported prostheses.

    Individual cost for each person included in the intervention group. For the intervention group, the cost of oral rehabilitation is calculated based on the patient's dental record.

    Measured: 14 months

  14. Change in nutritional quality scores assessed by UK Diabetes and Diet Questionnaire (UKDDQ) questionnaire from randomization to 9 months post-randomization.

    Dietary quality will be assessed using the UK Diabetes and Diet Questionnaire (UKDDQ). The questionnaire consists of 20 items, each scored from 0 to 5, where 0 represents the healthiest dietary option and 5 the least healthy option. The UKDDQ score is calculated by summing the item scores and dividing the total by 20. Scores range from 0 to 5, with lower scores indicating healthier dietary habits and higher scores indicating poorer dietary habits.

    Measured: 9 months

  15. Change in quality of lifes scores assessed by Oral Health Impact Profile-14 (OHIP-14) total score from randomization to 9 months post-randomization.

    Oral health-related quality of life will be assessed using the Oral Health Impact Profile-14 (OHIP-14) questionnaire. The questionnaire contains 14 items, each scored on a 5-point scale ranging from 0 ("never") to 4 ("very often"). The total score is calculated by summing all item scores and ranges from 0 to 56. Lower scores indicate a better oral health-related quality of life and less impact of oral conditions on daily life, whereas higher scores indicate a greater negative impact of oral health problems.

    Measured: 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted24 Jun 2026
  2. Study start15 Nov 2026 (estimated)
  3. Primary completion15 Aug 2030 (estimated)
  4. Study completion15 Aug 2030 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
140 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07666529
Sponsor's protocol ID
APHP251243
Other IDs
N° IDRCB : 2025-A02621-48
Acronym
DIABETEETH
Status last verified
Apr 2026
First submitted
8 Jun 2026
Last updated
24 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Replacement of one pair of molars in people with Type 2 Diabetes, run by Assistance Publique - Hôpitaux de Paris.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Martin BIOSSE-DUPLAN, DDS, Phd (+33 1 53 11 18 00, martin.biosse-duplan@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in HbA1c (%) from baseline (randomization) to 9 months post-randomization. (time frame: 9 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.

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