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

Civil Hospices of Lyon

Status: Not yet enrolling

Conditions: Periodontal Disease

Treatments: Procedure: Innovative periodontal monitoring (SuP innovative)

Study type: Interventional

Funder types: Other

Identifiers

NCT07165171

69HCL23_0377

2024-A01407-40 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 516 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• -- 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.

Exclusion criteria

• 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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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516 participants in 2 patient groups

Intervention group: SuP innovant (sending Short Message Service - SMS)

Experimental group

Description:

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.

Treatment:

Procedure: Innovative periodontal monitoring (SuP innovative)

Control group: SuP standard

No Intervention group

Description:

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).