Periodontal Follow-up and Glycemy in Patients With Type 2 Diabetes
GlyCoSup
Glycemy After Periodontal Treatment in Patients With Type 2 Diabetes: a Randomized Controlled Trial Comparing Innovative Versus Standard Periodontal Follow-up
2 other identifiers
interventional
516
1 country
8
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Oct 2025
Longer than P75 for not_applicable
8 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2025
CompletedFirst Posted
Study publicly available on registry
September 10, 2025
CompletedStudy Start
First participant enrolled
October 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2030
September 10, 2025
September 1, 2025
4 years
August 13, 2025
September 2, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HbA1c level (expressed as a %)
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.
At 2 years after the date of randomization.
Secondary Outcomes (7)
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.
- +2 more secondary outcomes
Study Arms (2)
Intervention group: SuP innovant (sending Short Message Service - SMS)
EXPERIMENTALFor 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.
Control group: SuP standard
NO INTERVENTIONFor 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).
Interventions
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.
Eligibility Criteria
You may qualify if:
- \-- 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.
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (8)
Hôpital Charles Foix
Ivry-sur-Seine, 94200, France
Centre Hospitalo-Universitaire de Lille
Lille, 59000, France
Hospices Civils de Lyon, Centre de Soins Dentaires.
Lyon, 69007, France
Centre Hospitalo-Universitaire de Nantes
Nantes, 44000, France
Centre Hospitalo-Universitaire de Rennes
Rennes, 35000, France
Cabinet libéral
Saint-Victor-de-Cessieu, 38110, France
Hôpitaux universitaires de Strasbourg
Strasbourg, 67000, France
Centre Hospitalo-Universitaire de Toulouse
Toulouse, 31300, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 13, 2025
First Posted
September 10, 2025
Study Start
October 1, 2025
Primary Completion (Estimated)
October 1, 2029
Study Completion (Estimated)
October 1, 2030
Last Updated
September 10, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will not share