Type I Diabetes and Non-surgical Periodontal Treatment

NCT05569525 | Active Not Recruiting

• 1 other identifier: DIODO
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Glycated hemoglobin (HbA1c)

  Glycated hemoglobin (HbA1c) to evaluate glycemic variability measured as a percentage (%).

  6 months after the non-surgical periodontal treatment

Secondary Outcomes (2)

• Standard Deviation (SD) of glycaemia

  6 months after the non-surgical periodontal treatment

• Glucose coefficient of variability (CV)

  6 months after the non-surgical periodontal treatment

Study Arms (2)

Test

EXPERIMENTAL

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

Procedure: Non-surgical periodontal therapy

Control

ACTIVE COMPARATOR

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

Procedure: Non-surgical periodontal therapy

Interventions

Non-surgical periodontal therapy PROCEDURE

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

Control; Test

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• Contraindications for non-surgical periodontal therapy
• Pregnancy
• History of other systemic disease (cancer, HIV, bone metabolic dysease, Head and Neck Radiotherapy, Immunosuppressive/modulating therapy)

Sponsors & Collaborators

• University of Florence: lead

Study Sites (1)

Università degli Studi di Firenze

Florence, FI, 50134, Italy

Location

MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Mouth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: October 3, 2022
• First Posted: October 6, 2022
• Study Start: November 6, 2022
• Primary Completion: November 10, 2023
• Study Completion: December 10, 2025
• Last Updated: December 6, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)