The Effects of Periodontal Therapy on Gingival Crevicular Fluid NLRP3,Caspase-1,IL-1β Levels in Children With Gingivitis

Not Applicable

Recruiting

• Conditions: Gingivitis
• Interventions: Procedure: Periodontal theraphy

• Registration Number: NCT06507280
• Lead Sponsor: Aydin Adnan Menderes University

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.

Detailed Description

After being informed about the study and potential risks, necessary periodontal measurements will be performed and gingival crevicular fluid will be collected from all patients who gave written informed consent, and patients with gingivitis will be followed up on the 7th and 30th day after periodontal treatment.

Study Timeline

• Study Start: 2024-02-01
• Status Verified: 2024-07
• Study First Submitted: 2024-07-02
• Study First Submitted QC: 2024-07-11
• Last Update Submitted: 2024-07-11
• Study First Posted: 2024-07-18
• Last Update Posted: 2024-07-18
• Primary Completion: 2024-09-01
• Study Completion: 2025-01-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Inclusion criteria for the group with gingivitis;

• Systemically healthy
• 11-14 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.

Inclusion criteria for the healthy group;

• Systemically healthy
• 11-14 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.

Exclusion Criteria

• In need of endodontic and restorative treatment
• Systemically unhealthy
• Patients who do not give verbal or written consent

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Gingivitis Group	Periodontal theraphy	In 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.

Primary Outcome Measures

Name	Time	Method
Caspase-1	Baseline	Caspase-1 level
NLRP3	Baseline	NOD-, LRR- and pyrin domain-containing protein 3 level
IL-1 Beta	Baseline	Interleukin-1 Beta level

Secondary Outcome Measures

Name	Time	Method
Caspase-1	7. days -30. days	Caspase-1 level
NLRP3	7. days - 30. days	NOD-, LRR- and pyrin domain-containing protein 3 level
IL-1 Beta	7. days-30. days	Interleukin-1 Beta level

Trial Locations

Locations (1)

Sultan Keles; 🇹🇷 Aydın, Turkey