Type I Diabetes and Non-surgical Periodontal Treatment

• Sponsor: University of Florence (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05569525
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 18.1
• Patients Per Site Per Month: 5.5

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 1 Diabetes; Periodontitis; Periodontal Diseases; Diabetes; Diabetes Mellitus; Diabetes Mellitus, Type 1	Procedure: Non-surgical periodontal therapy	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effects of Non-surgical Periodontal Therapy on the Glycemic Variability of Periodontal Patients Affected by Type I Diabetes. A Randomized Clinical Trial.
• Anticipated Study Start Date: Nov 6, 2022
• Anticipated Primary Completion Date: Nov 10, 2023
• Anticipated Study Completion Date: May 10, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test Patients receiving non-surgical periodontal treatment within 1 week from enrollment.	Procedure: Non-surgical periodontal therapy; Non-surgical periodontal therapy according to the full-mouth debridement protocol.
Active Comparator: Control Patients receiving non-surgical periodontal treatment 6 months after the enrollment.	Procedure: Non-surgical periodontal therapy; Non-surgical periodontal therapy according to the full-mouth debridement protocol.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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)

2. 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 (%).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Università degli Studi di Firenze	Firenze	FI	Italy	50134

Sponsors and Collaborators

• University of Florence

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dr. Francesco Cairo, Prof., University of Florence
• ClinicalTrials.gov Identifier: NCT05569525
• Other Study ID Numbers: DIODO
• First Posted: Oct 6, 2022
• Last Update Posted: Oct 7, 2022
• Last Verified: Oct 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Periodontitis; Periodontal Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1

Study Results

No Results Posted as of Oct 7, 2022