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Type I Diabetes and Non-surgical Periodontal Treatment

Primary Purpose

Type 1 Diabetes, Periodontitis, Periodontal Diseases

Status
Not yet recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Non-surgical periodontal therapy
Sponsored by
University of Florence
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Università degli Studi di Firenze

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Test

Control

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Standard Deviation (SD) of glycaemia
Standard Deviation: the spread of glucose readings around the average (mg/dl)
Glucose coefficient of variability (CV)
CV is a calculation: dividing the SD by the mean glucose and multiplying by 100 to get a percentage (%).

Full Information

First Posted
October 3, 2022
Last Updated
October 6, 2022
Sponsor
University of Florence
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1. Study Identification

Unique Protocol Identification Number
NCT05569525
Brief Title
Type I Diabetes and Non-surgical Periodontal 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.
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 6, 2022 (Anticipated)
Primary Completion Date
November 10, 2023 (Anticipated)
Study Completion Date
May 10, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Florence

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes, Periodontitis, Periodontal Diseases, Diabetes, Diabetes Mellitus, Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test
Arm Type
Experimental
Arm Description
Patients receiving non-surgical periodontal treatment within 1 week from enrollment.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Patients receiving non-surgical periodontal treatment 6 months after the enrollment.
Intervention Type
Procedure
Intervention Name(s)
Non-surgical periodontal therapy
Intervention Description
Non-surgical periodontal therapy according to the full-mouth debridement protocol.
Primary Outcome Measure Information:
Title
Glycated hemoglobin (HbA1c)
Description
Glycated hemoglobin (HbA1c) to evaluate glycemic variability measured as a percentage (%).
Time Frame
6 months after the non-surgical periodontal treatment
Secondary Outcome Measure Information:
Title
Standard Deviation (SD) of glycaemia
Description
Standard Deviation: the spread of glucose readings around the average (mg/dl)
Time Frame
6 months after the non-surgical periodontal treatment
Title
Glucose coefficient of variability (CV)
Description
CV is a calculation: dividing the SD by the mean glucose and multiplying by 100 to get a percentage (%).
Time Frame
6 months after the non-surgical periodontal treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesco Cairo, Prof.
Phone
+393392961343
Email
francesco.cairo@unifi.it
First Name & Middle Initial & Last Name or Official Title & Degree
Luigi Barbato, Dr.
Phone
+393299457556
Email
luigi.barbato@unifi.it
Facility Information:
Facility Name
Università degli Studi di Firenze
City
Firenze
State/Province
FI
ZIP/Postal Code
50134
Country
Italy
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Cairo, Prof.
Phone
+393392961343
Email
francesco.cairo@unifi.it

12. IPD Sharing Statement

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Type I Diabetes and Non-surgical Periodontal Treatment

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