Type I Diabetes and Non-surgical Periodontal Treatment

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

Status

Active, not recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05569525

Enrollment

100

Registered

2022-10-06

Start date

2022-11-06

Completion date

2025-12-10

Last updated

2024-12-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

PROCEDURENon-surgical periodontal therapy

Non-surgical periodontal therapy according to the full-mouth debridement protocol.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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)

Design outcomes

Primary

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

Secondary

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

Countries

Italy

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026