Type I Diabetes and Non-surgical Periodontal Treatment

December 3, 2024 updated by: Dr. Francesco Cairo, University of Florence

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
    • FI
      • Firenze, FI, Italy, 50134
        • Università degli studi di Firenze

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glycated hemoglobin (HbA1c)
Time Frame: 6 months after the non-surgical periodontal treatment
Glycated hemoglobin (HbA1c) to evaluate glycemic variability measured as a percentage (%).
6 months after the non-surgical periodontal treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Standard Deviation (SD) of glycaemia
Time Frame: 6 months after the non-surgical periodontal treatment
Standard Deviation: the spread of glucose readings around the average (mg/dl)
6 months after the non-surgical periodontal treatment
Glucose coefficient of variability (CV)
Time Frame: 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 (%).
6 months after the non-surgical periodontal treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florence

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 6, 2022

Primary Completion (Actual)

November 10, 2023

Study Completion (Estimated)

December 10, 2025

Study Registration Dates

First Submitted

October 3, 2022

First Submitted That Met QC Criteria

October 3, 2022

First Posted (Actual)

October 6, 2022

Study Record Updates

Last Update Posted (Estimated)

December 6, 2024

Last Update Submitted That Met QC Criteria

December 3, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DIODO

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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