Type I Diabetes and Non-surgical Periodontal Treatment

University of Florence (UNIFI)

Status: Active, not recruiting

Conditions: Diabetes Mellitus, Type 1; Periodontitis; Diabetes; Type 1 Diabetes; Diabetes Mellitus; Periodontal Diseases

Treatments: Procedure: Non-surgical periodontal therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT05569525

DIODO

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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100 participants in 2 patient groups

Test

Experimental group

Description:

Patients receiving non-surgical periodontal treatment within 1 week from enrollment.

Treatment:

Procedure: Non-surgical periodontal therapy

Control

Active Comparator group

Description:

Patients receiving non-surgical periodontal treatment 6 months after the enrollment.

Treatment:

Procedure: Non-surgical periodontal therapy