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Active, Not Recruiting

NCT Number: NCT05569525

Type I Diabetes and Non-surgical Periodontal Treatment

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Type 1 Diabetes Autoimmune Diseases Diabetes Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Mouth Diseases Nutritional and Metabolic Diseases Periodontal Diseases Periodontitis Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Università degli Studi di Firenze

Florence, FI, 50134, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Non-surgical periodontal therapy

Procedure

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

Primary outcomes

  1. 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

  1. Standard Deviation (SD) of glycaemia

    Time frame: 6 months after the non-surgical periodontal treatment

    Standard Deviation: the spread of glucose readings around the average (mg/dl)

  2. Glucose coefficient of variability (CV)

    Time frame: 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 (%).

Sponsors and collaborators

Lead sponsor

University of Florence

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2025
First posted
Oct 6, 2022
Registry last updated
Dec 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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