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OpenTrials
Completed

NCT Number: NCT06604013

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

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

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Key information

Conditions

Periodontal Diseases Body Weight Mouth Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Obesity, Morbid Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomatognathic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dental Medicine, Al-Azhar University Assiut Branch

Asyut, Asyut Governorate, 71524, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

non-surgical full-mouth periodontal therapy without using adjunct disinfectants

Procedure

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

GCF level of adiponectin and resistin

Diagnostic Test

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

Primary outcomes

  1. adiponectin level in gingival crevicular fluid

    Time frame: From enrollment to the end of treatment results assessment at 12 weeks

  2. resistin level in gingival crevicular fluid

    Time frame: From enrollment to the end of treatment results assessment at 12 weeks

Secondary outcomes

  1. O'Leary Plaque score

    Time frame: From enrollment to the end of treatment results assessment at 12 weeks

  2. bleeding on probing percentage (BoP)

    Time frame: From enrollment to the end of treatment results assessment at 12 weeks

  3. clinical attachment level (CAL)

    Time frame: From enrollment to the end of treatment results assessment at 12 weeks

  4. probing pocket depth

    Time frame: From enrollment to the end of treatment results assessment at 12 weeks

Other outcomes

  1. Body Mass Index (BMI)

    Time frame: From enrollment time only

  2. glycated hemoglobin (HbA1c)

    Time frame: From enrollment time only

Sponsors and collaborators

Lead sponsor

Al-Azhar University

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 19, 2024
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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