Impact of Non-surgical Periodontal Treatment of miRNome
Effects of Minimally Non-surgical Periodontal Treatment Versus Quadrantwise Subgingival Instrumentations on miRNome in Gingival Tissues
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 by means of minimally invasive approach MINST or Q-SI (quadrantwise) approach in subjects with periodontitis on miRNome in gingival crevicular fluid
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 Apr 2024
Shorter than P25 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
First Submitted
Initial submission to the registry
April 20, 2024
CompletedStudy Start
First participant enrolled
April 20, 2024
CompletedFirst Posted
Study publicly available on registry
April 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 22, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
October 15, 2024
CompletedApril 24, 2024
April 1, 2024
5 months
April 20, 2024
April 20, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
Probing Pocket Depth
Reduction in Probing Pocket Depth after treatnebt
6-months
Study Arms (2)
MINST non surgical periodontal treatment
EXPERIMENTALPeriodontitis patients treated by means of MINST. Patients were treated with non-surgical MINST periodontal treatment in a single session.
Q-SI non surgical periodontal treatment
ACTIVE COMPARATORPeriodontitis patients treated by means of Q-SI. Patients were treated with non-surgical quadrantwise periodontal treatment in 4 sessions, 1 session per week.
Interventions
Probin Pocket Depth reduction in millimetres before and after treatment
Eligibility Criteria
You may qualify if:
- Diagnosis of Periodontitis
You may not qualify if:
- Periodontal treatment
- Use of antibiotics, NSAIDs, and immunosuppressants during the last 6 months
- Pregnancy
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 Officials
- PRINCIPAL INVESTIGATOR
Gaetano Isola
Università degli Studi di Catania
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- Sealed envelopes
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
April 20, 2024
First Posted
April 24, 2024
Study Start
April 20, 2024
Primary Completion
September 22, 2024
Study Completion
October 15, 2024
Last Updated
April 24, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- 1-year
- Access Criteria
- Pubmed
Study results