Effects of Non-surgical Periodontal Therapy on the Glycemic Variability of Periodontal Patients Affected by Type I Diabetes. a Randomized Clinical Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- University of Florence
- Enrollment
- 100
- Locations
- 2
- Primary Endpoint
- Glycated hemoglobin (HbA1c)
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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)
Outcomes
Primary Outcomes
Glycated hemoglobin (HbA1c)
Time Frame: 6 months after the non-surgical periodontal treatment
Glycated hemoglobin (HbA1c) to evaluate glycemic variability measured as a percentage (%).
Secondary Outcomes
- Standard Deviation (SD) of glycaemia(6 months after the non-surgical periodontal treatment)
- Glucose coefficient of variability (CV)(6 months after the non-surgical periodontal treatment)
Investigators
Dr. Francesco Cairo
Prof.
University of Florence