NCT07165171

Periodontal Follow-up and Glycemy in Patients With Type 2 Diabetes

Glycemy After Periodontal Treatment in Patients With Type 2 Diabetes: a Randomized Controlled Trial Comparing Innovative Versus Standard Periodontal Follow-up

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 516 (estimated)
• Sponsor: Hospices Civils de Lyon · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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. Visits every 3 months are generally recommended at the beginning, in order to regularly reinforce HBD advice. However, adherence to the SuP is difficult to obtain in the long term. In orthodontic patients, the use of reminder systems (SMS, emails, mobile applications, etc.) has a positive effect on HBD and periodontal criteria and would improve the rate of attendance at appointments in the medium term (3-12 months). A reminder and reinforcement system for HBD advice could therefore be integrated into the SuP in order to improve HBD and longer-term adherence 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. This is a comparative experimental study to evaluate the effectiveness of a new monitoring strategy for type 2 diabetic patients who have been treated for periodontitis, a randomized controlled trial including an implementation study using a mixed methods approach (quantitative and qualitative). The research will take place in 7 hospitals (Lille, Lyon, Nantes, Paris, Rennes, Strasbourg, Toulouse) and 7 privates dental centers in France. Two types of care are proposed after periodontal treatment (all patients included will have previously benefited from standard periodontal treatment in the different centers). The two groups compared will be: * For the Experimental Group: Innovative periodontal monitoring. * For the Control Group: Standard periodontal follow-up. The primary endpoint is the HbA1c level (expressed in %) at 2 years after the date of randomization. The HbA1c level at 2 years will be collected by performing a routine dosage, in the patient's usual laboratory. The target population of the GlyCoSuP project concerns adults with type 2 diabetes who have been treated for periodontitis. After increasing by 10% to take into account those lost to follow-up, the total number of patients to be included will be 516 (258 patients per arm). The duration of the inclusion period will be 24 months and the participation for each subject will be 24 months. In total, the total duration of the study will be 48 months.

Conditions

• Periodontal Disease

Interventions

Type	Name	Description
PROCEDURE	Innovative periodontal monitoring (SuP innovative)	Different types of SMS messages will be sent alternately. * Type 1 SMS: SMS providing targeted medical information specifically for diabetic patients. * Type 2 SMS: Interactive SMS text messages written in the form of questions. * Type 3 SMS: Before each scheduled periodontal follow-up visit (every 3 months), a reminder SMS will be sent with the date, time, and location of the appointment. The SMS messages are intended for patients in the experimental group. Over these 24 months, the following are planned per patient: * 1 Type 1 SMS/week (medical advice or information); * 1 Type 2 SMS/month (interactive with suggested answers); * 1 Type 3 SMS every 3 months (appointment reminder): 1 per visit. The various text messages will be scheduled from the beginning of the periodontal follow-up.

Timeline

• Start date: 2025-10-01
• Primary completion: 2029-10-01
• Completion: 2030-10-01
• First posted: 2025-09-10
• Last updated: 2025-09-10

Locations

8 sites across 1 country: France