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Clinical Trials in Italy / NCT05569525
Active, not recruiting Not applicable

Type I Diabetes and Non-surgical Periodontal Treatment

NCT05569525 · tracked via the Priya Life Science Italy tracker
Sponsor
University of Florence
Phase
Not applicable
Started
2022-11-06
Last updated
2024-12-06

Condition(s) studied

Type 1 DiabetesPeriodontitisPeriodontal DiseasesDiabetesDiabetes MellitusDiabetes Mellitus, Type 1

Investigational drug(s) / intervention(s)

Non-surgical periodontal therapy

Non-surgical periodontal therapy: Non-surgical periodontal therapy according to the full-mouth debridement protocol.

Study summary

Current evidence suggests a bidirectional association between periodontitis and diabetes. Periodontal therapy improves short term HbA1c levels and is safe to perform. Most studies are focused on type 2 Diabetes. Literature about the correlation between periodontitis and type 1 diabetes is scarce, since no randomized clinical trials have been performed.

The objective of the present clinical investigation is to evaluate the effects of nonsurgical treatment of periodontal disease on glycemic variability in patients with type 1 diabetes (T1DM). The hypothesis is that nonsurgical periodontal therapy affects glycemic variability in terms of time spent in hyperglycemia.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Diagnosis of Type 1 diabetes * Patients under treatment in the department of Diabetology of AOU Careggi having a microinfusor for continuous subcutaneous insulin infusion (CSII) and a Flash Glucose Monitoring (FGM) device * Diagnosis of periodontitis (all stages and grades) Exclusion Criteria: * Contraindications for non-surgical periodontal therapy * Pregnancy * History of other systemic disease (cancer, HIV, bone metabolic dysease, Head and Neck Radiotherapy, Immunosuppressive/modulating therapy)

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Università degli Studi di Firenze Florence FI

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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 NCT05569525 on ClinicalTrials.gov ↗ ← All trials in Italy