Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
NA
100 participants
INTERVENTIONAL
2022-11-06
2025-12-10
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Test
Patients receiving non-surgical periodontal treatment within 1 week from enrollment.
Non-surgical periodontal therapy
Non-surgical periodontal therapy according to the full-mouth debridement protocol.
Control
Patients receiving non-surgical periodontal treatment 6 months after the enrollment.
Non-surgical periodontal therapy
Non-surgical periodontal therapy according to the full-mouth debridement protocol.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Non-surgical periodontal therapy
Non-surgical periodontal therapy according to the full-mouth debridement protocol.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Pregnancy
* History of other systemic disease (cancer, HIV, bone metabolic dysease, Head and Neck Radiotherapy, Immunosuppressive/modulating therapy)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Florence
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr. Francesco Cairo
Prof.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Università degli Studi di Firenze
Florence, FI, Italy
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DIODO
Identifier Type: -
Identifier Source: org_study_id