Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Test | Experimental | Patients receiving non-surgical periodontal treatment within 1 week from enrollment. |
|
| Control | Active Comparator | Patients receiving non-surgical periodontal treatment 6 months after the enrollment. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-surgical periodontal therapy | Procedure | Non-surgical periodontal therapy according to the full-mouth debridement protocol. |
|
| 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 |
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Università degli Studi di Firenze | Florence | FI | 50134 | Italy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D010518 | Periodontitis |
| D010510 | Periodontal Diseases |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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 |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |