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NCT05569525Active, not recruiting

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.

Source: ClinicalTrials.gov · Last updated 6 Dec 2024

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
100 (estimated)
First submitted
3 Oct 2022
Start date
6 Nov 2022
Primary completion date
10 Nov 2023
Lead sponsor
University of Florence
NCT number
NCT05569525

What you commit to

  • Study type: Interventional
  • Planned participants: 100
  • From 6 Nov 2022 to the primary completion date, 10 Nov 2023
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study design.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Contraindications for non-surgical periodontal therapy

Other illness

  • History of other systemic disease (cancer, HIV, bone metabolic dysease, Head and Neck Radiotherapy, Immunosuppressive/modulating therapy)

Other

  • Pregnancy

Who the study is looking for

  • 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)

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Universita degli Studi di Firenze
Coordinator of this site? Confirm its status
FlorenceItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.