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

NCT06604013 | Completed DMC FDA Device

• 1 other identifier: Obesity and Periodontitis
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Conditions

Periodontal Diseases; Obesity, Morbid

Keywords

resistin, adiponectin, periodontitis Grading, periodontal therapy

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 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

Other Outcomes (2)

• Body Mass Index (BMI)

  From enrollment time only

• glycated hemoglobin (HbA1c)

  From enrollment time only

Study Arms (4)

mild periodontitis (first stage, grade B)

ACTIVE COMPARATOR

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; Diagnostic Test: GCF level of adiponectin and resistin

moderate periodontitis (second stage, grade B)

ACTIVE COMPARATOR

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; Diagnostic Test: GCF level of adiponectin and resistin

severe periodontitis (third stage, grade B)

ACTIVE COMPARATOR

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; Diagnostic Test: GCF level of adiponectin and resistin

very severe periodontitis (forth stage, grade C)

ACTIVE COMPARATOR

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; Diagnostic Test: GCF level of adiponectin and resistin

Interventions

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

mild periodontitis (first stage, grade B); moderate periodontitis (second stage, grade B); severe periodontitis (third stage, grade B); very severe periodontitis (forth stage, grade C)

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

mild periodontitis (first stage, grade B); moderate periodontitis (second stage, grade B); severe periodontitis (third stage, grade B); very severe periodontitis (forth stage, grade C)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Al-Azhar University: lead

Study Sites (1)

Faculty of Dental Medicine, Al-Azhar University Assiut Branch

Asyut, Asyut Governorate, 71524, Egypt

Location

Related Publications (3)

• 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.

  PMID: 16104844 BACKGROUND

• 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.

  PMID: 19740705 BACKGROUND

• 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.

  PMID: 10674959 BACKGROUND

MeSH Terms

Conditions

Periodontal Diseases; Obesity, Morbid

Condition Hierarchy (Ancestors)

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

Study Officials

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: lecturer

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: September 19, 2024
• Study Start: September 10, 2023
• Primary Completion: April 23, 2024
• Study Completion: August 29, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)