Type I Diabetes and Non-surgical Periodontal Treatment

Not Applicable

Active, not recruiting

• Conditions: Periodontitis; Periodontal Diseases; Diabetes; Type 1 Diabetes; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Interventions: Procedure: Non-surgical periodontal therapy

• Registration Number: NCT05569525
• Lead Sponsor: University of Florence

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-03
• Study First Submitted QC: 2022-10-03
• Study First Posted: 2022-10-06
• Study Start: 2022-11-06
• Primary Completion: 2023-11-10
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06
• Study Completion: 2025-12-10

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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)

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Non-surgical periodontal therapy	Patients receiving non-surgical periodontal treatment 6 months after the enrollment.
Test	Non-surgical periodontal therapy	Patients receiving non-surgical periodontal treatment within 1 week from enrollment.

Primary Outcome Measures

Name	Time	Method
Glycated hemoglobin (HbA1c)	6 months after the non-surgical periodontal treatment	Glycated hemoglobin (HbA1c) to evaluate glycemic variability measured as a percentage (%).

Secondary Outcome Measures

Name	Time	Method
Standard Deviation (SD) of glycaemia	6 months after the non-surgical periodontal treatment	Standard Deviation: the spread of glucose readings around the average (mg/dl)
Glucose coefficient of variability (CV)	6 months after the non-surgical periodontal treatment	CV is a calculation: dividing the SD by the mean glucose and multiplying by 100 to get a percentage (%).

Trial Locations

Locations (1)

Università degli Studi di Firenze; 🇮🇹 Firenze, FI, Italy