Glycemy After Periodontal Treatment in Patients With Type 2 Diabetes: a Randomized Controlled Trial Comparing Innovative Versus Standard Periodontal Follow-up
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 516
- 试验地点
- 8
- 主要终点
- HbA1c level (expressed as a %)
研究概览
简要总结
Diabetes is a disease in which the majority of these patients have type 2 diabetes, linked to poor use of insulin by the body.
Periodontitis is a chronic disease characterized by an immuno-inflammatory reaction with local production of inflammatory mediators (IL6, TNF-alpha, etc.) and contributes to the increase in the systemic inflammatory load with increased levels of C-reactive protein.
Periodontitis is frequently found in diabetic patients; it is considered a complication of diabetes. Poor glycemic control in diabetes is associated with poor periodontal health, while periodontal infection is associated with dysglycemia and increased insulin resistance.
Periodontal treatment has been shown to reduce HbA1C levels and thus the risk of complications in diabetic patients.
The main objective is to evaluate the impact of innovative periodontal monitoring (with reminder systems and reinforcement of advice by SMS) versus standard periodontal monitoring on the glycemic control of diabetic patients treated for periodontitis, 2 years after the start of periodontal monitoring.
详细描述
Diabetes is a disease in which the majority of these patients have type 2 diabetes, linked to poor use of insulin by the body.
Periodontitis is a chronic disease characterized by an immuno-inflammatory reaction with local production of inflammatory mediators (IL6, TNF-alpha, etc.) and contributes to the increase in the systemic inflammatory load with increased levels of C-reactive protein.
Periodontitis is frequently found in diabetic patients; it is considered a complication of diabetes. Poor glycemic control in diabetes is associated with poor periodontal health, while periodontal infection is associated with dysglycemia and increased insulin resistance.
Periodontal treatment has been shown to reduce HbA1C levels and thus the risk of complications in diabetic patients.
However, periodontitis is a recurring disease; The implementation of periodontal monitoring (SuP) is essential throughout life after periodontal treatment, in order to prevent relapses. This monitoring, which must be carried out for life, includes the reassessment of periodontal criteria, professional instrumentation and oral hygiene (HBD) advice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •-- Adult aged 18 years or older;
- •Presenting with type 2 diabetes (under ALD), balanced or not, for 6 months or more;
- •Having been treated in the previous 6 months for periodontitis (stages 1 to 4 according to the new classification of periodontal and peri-implant diseases EFP-AAP 2018) in one of the participating centers and presenting a clinical situation allowing the transition to the periodontal follow-up phase (; (absence or limited number of sites presenting clinical signs of persistent periodontal inflammation)
- •Presenting more than 6 teeth;
- •Possessing a smartphone or tablet with internet access;
- •Affiliated to social security;
- •Patient able to read, write and understand French
- •Having signed a consent to participate in the study.
排除标准
- •Patient presenting uncontrolled systemic diseases and diagnosed for less than 6 months or presenting a major aggravation of a systemic pathology according to the judgment of the investigator.
- •Pregnant or breastfeeding women;
- •Persons deprived of liberty by a judicial or administrative decision;
- •Adults subject to a legal protection measure (guardianship, curatorship).
研究组 & 干预措施
Intervention group: SuP innovant (sending Short Message Service - SMS)
For the Experimental Group: Innovative periodontal monitoring (SuP), consisting of:
- visits every 3 months during 24 months with reinforcement of HBD advice and professional instrumentation - supra- and subgingival debridement if necessary. (common to the control group)
- sending of different types of SMS: different types of SMS messages will be sent alternately.
The SMS messages are intended for patients in the experimental group. The proposed approach aims to maintain contact with the patient at home and strengthen their commitment to a good oral hygiene routine over the long term. Text messages will be sent via the French CURECALL platform.
The various text messages will be scheduled from the beginning of the periodontal follow-up.
干预措施: Innovative periodontal monitoring (SuP innovative) (Procedure)
Control group: SuP standard
For the Control Group: Standard periodontal follow-up (SuP), consisting of: visits every 3 months with reinforcement of HBD advice and professional instrumentation - supra- and subgingival debridement if necessary (common to the experimental group).
结局指标
主要结局
HbA1c level (expressed as a %)
时间窗: At 2 years after the date of randomization.
The HbA1c level will be collected by routine testing in the patient's usual laboratory. This endpoint will be collected without knowing the patient's group. To limit missing data, a letter will be sent to the healthcare professional responsible for the patient's diabetes management (of the two groups) at the time of inclusion. If necessary, their physician may be contacted to retrieve this data, with the patient's consent. During the previous visit, the patient will be reminded to bring their test results for the next visit. This will also be noted in the appointment reminder text message.
次要结局
- Periodontal criteria: - average probing depth (mm),(At inclusion and then every 3 months up to 24 months post-randomization.)
- Periodontal criteria: - bleeding index on probing (%),(At inclusion then every 3 months until up to 24 months post-randomization.)
- Periodontal criteria: - average clinical attachment level (mm),(At inclusion and then every 3 months up to 24 months post-randomization.)
- Periodontal criteria: - number of sites with a probing depth strictly greater than or equal to 4 mm (but with bleeding on probing),(at inclusion and then every 3 months up to 24 months post-randomization.)
- Periodontal criteria: - number of tooth loss,(at inclusion and then every 3 months up to 24 months post-randomization.)
- Periodontal criteria: - number of sites re-instrumented by debridement/root planing(at inclusion and then every 3 months up to 24 months post-randomization.)
- Diabetic Pathology Criteria: - HbA1c level (%),(At inclusion then every 3 months until 24 months post-randomization.)