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

NCT ID: NCT06604013

Last Updated: 2024-09-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-10

Study Completion Date

2024-08-29

Brief Summary

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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

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Conditions

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Periodontal Diseases Obesity, Morbid

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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

Intervention Type 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

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.

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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

Intervention Type 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

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type 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

Intervention Type 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

Interventions

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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

Intervention Type PROCEDURE

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Asem Mohammed Kamel Ali

lecturer

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bahaa Mohammed Badr, associate professor

Role: STUDY_DIRECTOR

Faculty of dental medicine Al-Azhar university Assiut Branch

Asem Mohammed kamel, lecturer

Role: STUDY_DIRECTOR

Faculty of dental medicine Al-Azhar university Assiut Branch

Locations

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Faculty of Dental Medicine, Al-Azhar University Assiut Branch

Asyut, Asyut Governorate, Egypt

Site Status

Countries

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Egypt

References

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Kusminski CM, McTernan PG, Kumar S. Role of resistin in obesity, insulin resistance and Type II diabetes. Clin Sci (Lond). 2005 Sep;109(3):243-56. doi: 10.1042/CS20050078.

Reference Type BACKGROUND
PMID: 16104844 (View on PubMed)

Filkova M, Haluzik M, Gay S, Senolt L. The role of resistin as a regulator of inflammation: Implications for various human pathologies. Clin Immunol. 2009 Nov;133(2):157-70. doi: 10.1016/j.clim.2009.07.013. Epub 2009 Sep 8.

Reference Type BACKGROUND
PMID: 19740705 (View on PubMed)

Cugini MA, Haffajee AD, Smith C, Kent RL Jr, Socransky SS. The effect of scaling and root planing on the clinical and microbiological parameters of periodontal diseases: 12-month results. J Clin Periodontol. 2000 Jan;27(1):30-6. doi: 10.1034/j.1600-051x.2000.027001030.x.

Reference Type BACKGROUND
PMID: 10674959 (View on PubMed)

Other Identifiers

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Obesity and Periodontitis

Identifier Type: -

Identifier Source: org_study_id

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