Gingival Crevicular Fluid of Adiponectin and Resistin As Predictable Implement in Staging and Grading System of Periodontitis

Not Applicable

Completed

• Conditions: Periodontal Diseases; Obesity, Morbid
• Interventions: Procedure: non-surgical full-mouth periodontal therapy without using adjunct disinfectants; Diagnostic Test: GCF level of adiponectin and resistin

• Registration Number: NCT06604013
• Lead Sponsor: Al-Azhar University

Brief Summary

The goal of this clinical trial is to evaluate the relationship between obesity and gingival crevicular fluid resistin and adiponectin in periodontitis patients as well as assess the effect of non-surgical periodontal therapy on their levels using ELISA in obese individuals. Researchers will compare different stages of periodontitis to see if degrees of inflammation and periodontal therapy related obesity

Detailed Description

Not available

Study Timeline

• Study Start: 2023-09-10
• Primary Completion: 2024-04-23
• Study Completion: 2024-08-29
• Status Verified: 2024-09
• Study First Submitted: 2024-09-16
• Study First Submitted QC: 2024-09-18
• Last Update Submitted: 2024-09-18
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19

Recruitment & Eligibility

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

Inclusion Criteria

• obese persons with Body Mass Index (BMI) more than 40 and suffering from periodontitis

Exclusion Criteria

• Patients receiving either antibiotics or non-steroidal anti- inflammatory at least 3 months prior to samples collection.
• Patients subjected to previous periodontal therapy 6 months before sampling. Patients with systemic or local inflammatory conditions other than periodontal disease.
• Neither lactating nor pregnant.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
mild periodontitis (first stage, grade B)	non-surgical full-mouth periodontal therapy without using adjunct disinfectants	mild periodontitis (first stage, grade B) manifesting CAL ≥ 1-2 mm, in corporation with percentage of bone loss level divided by age was 0.25-1% very year. patients received non-surgical full-mouth periodontal therapy without using adjunct disinfectants.
mild periodontitis (first stage, grade B)	GCF level of adiponectin and resistin	mild periodontitis (first stage, grade B) manifesting CAL ≥ 1-2 mm, in corporation with percentage of bone loss level divided by age was 0.25-1% very year. patients received non-surgical full-mouth periodontal therapy without using adjunct disinfectants.
moderate periodontitis (second stage, grade B)	non-surgical full-mouth periodontal therapy without using adjunct disinfectants	moderate periodontitis (second stage, grade B) manifesting CAL ≥ 3-4mm in corporation with percentage of bone loss level divided by age was 0.25-1% very year. patients received non-surgical full-mouth periodontal therapy without using adjunct disinfectants.
moderate periodontitis (second stage, grade B)	GCF level of adiponectin and resistin	moderate periodontitis (second stage, grade B) manifesting CAL ≥ 3-4mm in corporation with percentage of bone loss level divided by age was 0.25-1% very year. patients received non-surgical full-mouth periodontal therapy without using adjunct disinfectants.
severe periodontitis (third stage, grade B)	non-surgical full-mouth periodontal therapy without using adjunct disinfectants	severe periodontitis (third stage, grade B) manifesting CAL ≥ 5mm , in corporation with BoP increased than (30%), percentage of bone loss level divided by age was 0.25-1% very year. patients received non-surgical full-mouth periodontal therapy without using adjunct disinfectants
severe periodontitis (third stage, grade B)	GCF level of adiponectin and resistin	severe periodontitis (third stage, grade B) manifesting CAL ≥ 5mm , in corporation with BoP increased than (30%), percentage of bone loss level divided by age was 0.25-1% very year. patients received non-surgical full-mouth periodontal therapy without using adjunct disinfectants
very severe periodontitis (forth stage, grade C)	non-surgical full-mouth periodontal therapy without using adjunct disinfectants	very severe periodontitis (forth stage, grade C) manifesting CAL ≥ 5mm in corporation of percentage of bone loss level divided by age more than 1% very year. patients received non-surgical full-mouth periodontal therapy without using adjunct disinfectants
very severe periodontitis (forth stage, grade C)	GCF level of adiponectin and resistin	very severe periodontitis (forth stage, grade C) manifesting CAL ≥ 5mm in corporation of percentage of bone loss level divided by age more than 1% very year. patients received non-surgical full-mouth periodontal therapy without using adjunct disinfectants

Primary Outcome Measures

Name	Time	Method
adiponectin level in gingival crevicular fluid	From enrollment to the end of treatment results assessment at 12 weeks
resistin level in gingival crevicular fluid	From enrollment to the end of treatment results assessment at 12 weeks

Secondary Outcome Measures

Name	Time	Method
O'Leary Plaque score	From enrollment to the end of treatment results assessment at 12 weeks
bleeding on probing percentage (BoP)	From enrollment to the end of treatment results assessment at 12 weeks
clinical attachment level (CAL)	From enrollment to the end of treatment results assessment at 12 weeks
probing pocket depth	From enrollment to the end of treatment results assessment at 12 weeks

Trial Locations

Locations (1)

Faculty of Dental Medicine, Al-Azhar University Assiut Branch; 🇪🇬 Assiut, Asyut, Egypt