Type I Diabetes and Non-surgical Periodontal Treatment

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Procedure: Non-surgical periodontal therapy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycated hemoglobin (HbA1c) | 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 | 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) | 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 |