The Effects of Periodontal Therapy on Gingival Crevicular Fluid NLRP3,Caspase-1,IL-1β Levels in Children With Gingivitis
1 other identifier
interventional
60
1 country
1
Brief Summary
This study aims to determine the levels of NLRP3, caspase-1 and IL-1β concentrations in the gingival crevicular fluid of paediatric patients with gingivitis and their changes after periodontal treatment.
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 Feb 2024
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
February 1, 2024
CompletedFirst Submitted
Initial submission to the registry
July 2, 2024
CompletedFirst Posted
Study publicly available on registry
July 18, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2025
CompletedJuly 18, 2024
July 1, 2024
7 months
July 2, 2024
July 11, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
NLRP3
NOD-, LRR- and pyrin domain-containing protein 3 level
Baseline
Caspase-1
Caspase-1 level
Baseline
IL-1 Beta
Interleukin-1 Beta level
Baseline
Secondary Outcomes (3)
NLRP3
7. days - 30. days
Caspase-1
7. days -30. days
IL-1 Beta
7. days-30. days
Study Arms (2)
Gingivitis Group
EXPERIMENTALIn the first session, gingival crevicular fluid samples will be taken from teeth numbered 11,21, periodontal measurements will be made, plaques on the teeth will be cleaned and oral hygiene training will be performed. On the 7th and 30th days, gingival crevicular fluid will be taken again and periodontal measurements will be made.
Healthy Group
NO INTERVENTIONGingival crevicular fluid samples will be taken from teeth numbered 11,21, periodontal measurements will be made
Interventions
Eligibility Criteria
You may qualify if:
- Systemically healthy
- years old
- Permanent dentition
- No need for endodontic and restorative treatment
- Gingivitis with gingivitis
- Have verbally and in writing agreed to participate in the study and are willing to attend follow-up appointments regularly participants will be included in the study.
- Systemically healthy
- years old
- Permanent dentition
- No need for endodontic and restorative treatment
- Periodontally healthy
- Have verbally and in writing agreed to participate in the study and are willing to attend follow-up appointments regularly participants will be included in the study.
You may not qualify if:
- In need of endodontic and restorative treatment
- Systemically unhealthy
- Patients who do not give verbal or written consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sultan Keles
Aydin, 09100, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Prof. Dr.
Study Record Dates
First Submitted
July 2, 2024
First Posted
July 18, 2024
Study Start
February 1, 2024
Primary Completion
September 1, 2024
Study Completion
January 1, 2025
Last Updated
July 18, 2024
Record last verified: 2024-07
Data Sharing
- IPD Sharing
- Will not share