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Starting soon Not applicable

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

NCT07165171 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2025-10-01
Last updated
2025-09-10

Condition(s) studied

Periodontal Disease

Investigational drug(s) / intervention(s)

Innovative periodontal monitoring (SuP innovative)

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.

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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).

Primary outcome measure(s)

  • HbA1c level (expressed as a %) — 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.

Trial sites (8)

FacilityCityRegionStatus
Hôpital Charles Foix Ivry-sur-Seine France
Centre Hospitalo-Universitaire de Lille Lille France
Hospices Civils de Lyon, Centre de Soins Dentaires. Lyon France
Centre Hospitalo-Universitaire de Nantes Nantes France
Centre Hospitalo-Universitaire de Rennes Rennes France
Cabinet libéral Saint-Victor-de-Cessieu France
Hôpitaux universitaires de Strasbourg Strasbourg France
Centre Hospitalo-Universitaire de Toulouse Toulouse France
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07165171 on ClinicalTrials.gov ↗ ← All trials in France