Effect of Molar Replacement on Glycemic Control in Adults With Uncontrolled Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 140
研究概览
简要总结
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.
详细描述
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);
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
- •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