Type I Diabetes and Non-surgical Periodontal Treatment

Diabetes Clinical Trial

Official title:

Effects of Non-surgical Periodontal Therapy on the Glycemic Variability of Periodontal Patients Affected by Type I Diabetes. A Randomized Clinical Trial.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05569525
• Other study ID #: DIODO
• Status: Not yet recruiting
• Phase: N/A
• Start date: November 6, 2022
• Est. completion date: May 10, 2024

Study information

• Verified date: October 2022
• Source: University of Florence
• Contact: Francesco Cairo, Prof.
• Phone: +393392961343
• Email: francesco.cairo[@]unifi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100
• Est. completion date: May 10, 2024
• Est. primary completion date: November 10, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Italy	Università degli Studi di Firenze	Firenze	FI

Sponsors (1)

Lead Sponsor	Collaborator
University of Florence

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycated hemoglobin (HbA1c)	Glycated hemoglobin (HbA1c) to evaluate glycemic variability measured as a percentage (%).	6 months after the non-surgical periodontal treatment
Secondary	Standard Deviation (SD) of glycaemia	Standard Deviation: the spread of glucose readings around the average (mg/dl)	6 months after the non-surgical periodontal treatment
Secondary	Glucose coefficient of variability (CV)	CV is a calculation: dividing the SD by the mean glucose and multiplying by 100 to get a percentage (%).	6 months after the non-surgical periodontal treatment