Impact of Non-surgical Periodontal Therapy in the Improvement of Early Endothelial Dysfunction in Subjects With Periodontitis.
1 other identifier
interventional
60
1 country
1
Brief Summary
A double-blind randomized-controlled clinical trial is conducted in order to evaluate the impact of non-surgical periodontal treatment on endothelial dysfunction parameters in subjects with periodontitis and without any cardiovascular disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2020
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 7, 2020
CompletedFirst Submitted
Initial submission to the registry
June 7, 2023
CompletedFirst Posted
Study publicly available on registry
June 18, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 12, 2023
CompletedJuly 1, 2026
June 1, 2026
3.1 years
June 7, 2023
June 29, 2026
Conditions
Outcome Measures
Primary Outcomes (5)
Pulse Wave Velocity carotid-femoral (PWV-CF)
The speed of pulse wave propagation between carotid-femoral sites
8 weeks
Pulse Wave Velocity carotid-femoral (PWV-CR)
The speed of pulse wave propagation between carotid-radial sites
8 weeks
Carotid Intima-Media Thickness (CIMT)
The thickness of the carotid intima and media
8 weeks
Distensibility Coefficient (DC)
The relative change in luminal area during systole for a given pressure change (pulsed pressure), will be calculated assuming the lumen to be circular.
8 weeks
Advanced Glycation End products (AGEs)
A group of endogenous heterogeneous compounds that are constantly formed under physiological conditions with prooxidant and cytotoxic properties. Measurements are performed by fluorescence spectroscopy technique.
8 weeks
Study Arms (2)
Periodontitis - MINST
EXPERIMENTALSubjects diagnosed with periodontitis according to the most recent international guidelines and without cardiovascular diseases treated with MINST approach.
Periodontitis - Q-SI
PLACEBO COMPARATORSubjects with periodontitis and without CVD treated by Q-SI approach
Interventions
Subgingival biofilm ultrasonic debridement
Non surgical periodontal treatment using MINST approach
Eligibility Criteria
You may qualify if:
- Clinically diagnosed with periodontitis according to the EFP/AAP 2017 criteria.
You may not qualify if:
- Periodontal treatment, antibiotics, NSAIDs, immunosuppressants during the last 6 months.
- Pregnancy.
- Cardiovascular Diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
AOU Policlinico G. Rodolico
Catania, 95124, Italy
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Researcher
Study Record Dates
First Submitted
June 7, 2023
First Posted
June 18, 2023
Study Start
September 7, 2020
Primary Completion
October 30, 2023
Study Completion
December 12, 2023
Last Updated
July 1, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will not share