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

September 18, 2024 updated by: Asem Mohammed Kamel Ali, Al-Azhar University

Class III Obesity and Periodontitis: Gingival Crevicular Fluid of Adiponectin and Resistin As Predictable Implement in Staging and Grading System and Effects of Periodontal Therapy

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

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 Locations

  • Egypt
    • Asyut
      • Assiut, Asyut, Egypt, 71524
        • Faculty of Dental Medicine, Al-Azhar University Assiut Branch

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 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: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: mild periodontitis (first stage, grade B)
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.
Procedure: non-surgical full-mouth periodontal therapy without using adjunct disinfectants
Supragingival scaling was performed by Ultrasonic Scaler and manual scaling by sickle scaler . Subgingival scaling and root planing were accomplished with either universal or area specific Gracey curettes
Diagnostic test: GCF level of adiponectin and resistin
Gingival crevicular fluid (GCF) samples were gathered and relocated in phosphate buffer saline inside Eppendorf tube then t they were manipulated by commercially available enzyme-linked immuno-sorbent assay
Active Comparator: moderate periodontitis (second stage, grade B)
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.
Procedure: non-surgical full-mouth periodontal therapy without using adjunct disinfectants
Supragingival scaling was performed by Ultrasonic Scaler and manual scaling by sickle scaler . Subgingival scaling and root planing were accomplished with either universal or area specific Gracey curettes
Diagnostic test: GCF level of adiponectin and resistin
Gingival crevicular fluid (GCF) samples were gathered and relocated in phosphate buffer saline inside Eppendorf tube then t they were manipulated by commercially available enzyme-linked immuno-sorbent assay
Active Comparator: severe periodontitis (third stage, grade B)
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
Procedure: non-surgical full-mouth periodontal therapy without using adjunct disinfectants
Supragingival scaling was performed by Ultrasonic Scaler and manual scaling by sickle scaler . Subgingival scaling and root planing were accomplished with either universal or area specific Gracey curettes
Diagnostic test: GCF level of adiponectin and resistin
Gingival crevicular fluid (GCF) samples were gathered and relocated in phosphate buffer saline inside Eppendorf tube then t they were manipulated by commercially available enzyme-linked immuno-sorbent assay
Active Comparator: very severe periodontitis (forth stage, grade C)
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
Procedure: non-surgical full-mouth periodontal therapy without using adjunct disinfectants
Supragingival scaling was performed by Ultrasonic Scaler and manual scaling by sickle scaler . Subgingival scaling and root planing were accomplished with either universal or area specific Gracey curettes
Diagnostic test: GCF level of adiponectin and resistin
Gingival crevicular fluid (GCF) samples were gathered and relocated in phosphate buffer saline inside Eppendorf tube then t they were manipulated by commercially available enzyme-linked immuno-sorbent assay

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
adiponectin level in gingival crevicular fluid
Time Frame: From enrollment to the end of treatment results assessment at 12 weeks
From enrollment to the end of treatment results assessment at 12 weeks
resistin level in gingival crevicular fluid
Time Frame: From enrollment to the end of treatment results assessment at 12 weeks
From enrollment to the end of treatment results assessment at 12 weeks

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure
Time Frame
Body Mass Index (BMI)
Time Frame: From enrollment time only
From enrollment time only
glycated hemoglobin (HbA1c)
Time Frame: From enrollment time only
From enrollment time only

Collaborators and Investigators

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

Sponsor

Al-Azhar University

Investigators

  • Study Director: Bahaa Mohammed Badr, associate professor, Faculty of dental medicine Al-Azhar university Assiut Branch
  • Study Director: Asem Mohammed kamel, lecturer, Faculty of dental medicine Al-Azhar university Assiut Branch

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 10, 2023

Primary Completion (Actual)

April 23, 2024

Study Completion (Actual)

August 29, 2024

Study Registration Dates

First Submitted

September 16, 2024

First Submitted That Met QC Criteria

September 18, 2024

First Posted (Estimated)

September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 18, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Obesity and Periodontitis

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

Yes

product manufactured in and exported from the U.S.

Yes

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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