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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Enrollment
140
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.
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.
Time frame: 9 months
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.
Time frame: 9 months
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.
Time frame: 9 months
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.
Time frame: 9 months
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.
Time frame: 9 months
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.
Time frame: 9 months
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.
Time frame: 9 months
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.
Time frame: 9 months
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.
Time frame: 9 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 6 months
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.
Time frame: 14 months
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.
Time frame: 9 months
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.
Time frame: 9 months
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