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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
60

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Al-Azhar University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 10, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 23, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 29, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 16, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2024

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 19, 2024

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 18, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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