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

July 11, 2024 updated by: Sultan KELES, Aydin Adnan Menderes University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / 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 Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Turkey
      • Aydın, Turkey, 09100
        • Recruiting
        • Sultan Keles
        • Contact:
        • Sub-Investigator:
          • Nazlı Sevilmiş

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Gingivitis Group
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.
Procedure: Periodontal theraphy
periodontal therapy
No Intervention: Healthy Group
Gingival crevicular fluid samples will be taken from teeth numbered 11,21, periodontal measurements will be made

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NLRP3
Time Frame: Baseline
NOD-, LRR- and pyrin domain-containing protein 3 level
Baseline
Caspase-1
Time Frame: Baseline
Caspase-1 level
Baseline
IL-1 Beta
Time Frame: Baseline
Interleukin-1 Beta level
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
NLRP3
Time Frame: 7. days - 30. days
NOD-, LRR- and pyrin domain-containing protein 3 level
7. days - 30. days
Caspase-1
Time Frame: 7. days -30. days
Caspase-1 level
7. days -30. days
IL-1 Beta
Time Frame: 7. days-30. days
Interleukin-1 Beta level
7. days-30. days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Aydin Adnan Menderes University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

January 1, 2025

Study Registration Dates

First Submitted

July 2, 2024

First Submitted That Met QC Criteria

July 11, 2024

First Posted (Actual)

July 18, 2024

Study Record Updates

Last Update Posted (Actual)

July 18, 2024

Last Update Submitted That Met QC Criteria

July 11, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024/43

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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