ESTIMATION OF GINGIVAL CREVICULAR LEVEL OF YKL40

NCT03995615 | Unknown

• 1 other identifier: 02_D012_91499
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The presence of YKL- 40 an acute phase protein in both chronic periodontitis and rheumatoid arthritis. However, till date no studies has been done on the levels of gingival crevicular fluid YKL-40 following scaling and root planing, the present study which is first of its kind is designed to detect and estimate the gingival crevicular fluid YKL-40 levels in healthy patients, chronic periodontitis and patient with chronic periodontitis having rheumatoid arthritis at baseline and chronic periodontitis having rheumatoid arthritis 6 weeks post periodontal therapy (scaling and root planning \[SRP\]). This could throw more light on it and extend our knowledge on its role in both the conditions.

Conditions

Periodontitis and Rheumatoid Arthritis

Outcome Measures

Primary Outcomes (1)

• levels of YKL40 IN GCF

  To estimate the levels of gingival crevicular fluid YKL-40 in patients with healthy periodontium, chronic periodontitis and chronic periodontitis with rheumatoid arthritis following scaling and root planing

  6 WEEEKS

Study Arms (4)

Group I (Control)

NO INTERVENTION

• Group I (Control) - 15 periodontally healthy patient with probing depth\< 3mm and ≤ 10% sites with bleeding on probing.

• Group II

NO INTERVENTION

• Group II - 15 systemically healthy chronic periodontitis patient who had presented \>25% of sites with gingival bleeding ,surface demonstrating supra-gingival plaque accumulation and an absence of probing depth ≥ 4mm and clinical attachment level ≥3mm

• Group III

NO INTERVENTION

• Group III - 15 chronic periodontitis patient with a probing depth ≥ 5mm and relative attachment loss of ≥8mm and ≥ 10% sites with bleeding on probing present with radiographic evidence of bone loss and Rheumatoid arthritis with diseases active score 28\[DAS-28\] ≥3.2 to ≤5.1with out scaling and root planing

• Group IV

ACTIVE COMPARATOR

• Group IV - 15 chronic periodontitis patient with a probing depth ≥ 5mm and relative attachment loss of ≥8mm and ≥ 10% sites with bleeding on probing present with radiographic evidence of bone loss and Rheumatoid arthritis with diseases active score 28\[DAS-28\] ≥3.2 to ≤5.1 with scaling and root planing. Periodontal clinical parameters will be assessed

Procedure: scaling and root planing

Interventions

scaling and root planing PROCEDURE

* After initial clinical evaluation, supra gingival calculus removal will be done. GCF samples will be collected from the control and test groups (Baseline samples) using paper strips (ORAFLOW). ® Group III patients will undergo a through oral hygiene instructions, full mouth supra-gingival and sub- gingival scaling and root planing clinical parameters will be re-recorded 6 weeks later and a 2nd GCF samples will be collected from selected test site from each patients following periodontal intervention. * All the samples will be placed in eppendorf vials containing the buffer solution and samples will be stored at -800 c until the time of analysis by Enzyme -linked immune sorbent assay kit (ELISA) (GENX BIO) TM

• Group IV

Eligibility Criteria

• Age: 25 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• \. Age group of 25 to 55 years. 2. Patient diagnosed with active rheumatoid arthritis with DAS scoring between ≥3.2 to ≤5.1 3. Patient with generalized mild to moderate chronic periodontitis. 4. Patient who had not received any periodontal treatment in last six months. 5. Dentition with at least twenty functioning teeth. 6. Patient who are co-operative and able to attend follow-up.

You may not qualify if:

• \. Any systemic diseased such as diabetic mellitus and thyroid diseases. 2. Former and current smokers. 3. Pregnant and lactating females. 4. Usage of antibiotics or patients on Diseases Modifying Anti-Rheumatic Drugs (DMARD) that affects the periodontal status in the last six months.

Sponsors & Collaborators

• Krishnadevaraya College of Dental Sciences & Hospital: lead

Study Sites (1)

Krishnadevaraya college of dental sciences

Bangalore, Karnataka, 562157, India

RECRUITING

MeSH Terms

Conditions

Periodontitis; Arthritis, Rheumatoid

Interventions

Tooth Exfoliation; Root Planing

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Dental Physiological Phenomena; Digestive System and Oral Physiological Phenomena; Dental Scaling; Dental Prophylaxis; Periodontics; Dentistry; Subgingival Curettage; Preventive Dentistry

Study Officials

• RUDRAKSHI C, MDS

  Krishnadevaraya college of dental sciences , Banglore ,KARNATAKA , INDIA

  PRINCIPAL INVESTIGATOR

Central Study Contacts

RUDRAKSHI C, MDS

CONTACT

28467083; drrudrakshi@rediffmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor/ head of the department periodontology

Model Details: * Group I (Control) - 15 periodontally healthy patient with probing depth\< 3mm * Group II - 15 systemically healthy chronic periodontitis patient who had \>25% of sites with gingival bleeding and an absence of probing depth ≥ 4mm and clinical attachment level ≥3mm * Group III - 15 chronic periodontitis patient with a probing depth ≥ 5mm and relative attachment loss of ≥8mm and ≥ 10% sites with bleeding on probing present with radiographic evidence of bone loss and Rheumatoid arthritis with diseases active score 28\[DAS-28\] ≥3.2 to ≤5.1with out scaling and root planing. * Group IV - 15 chronic periodontitis patient with a probing depth ≥ 5mm and relative attachment loss of ≥8mm and ≥ 10% sites with bleeding on probing present with radiographic evidence of bone loss and Rheumatoid arthritis with diseases active score 28\[DAS-28\] ≥3.2 to ≤5.1 with scaling and root planing. Periodontal clinical parameters will be assessed.

Study Record Dates

• First Submitted: June 20, 2019
• First Posted: June 24, 2019
• Study Start: January 1, 2020
• Primary Completion: March 1, 2020
• Study Completion: October 1, 2021
• Last Updated: June 24, 2019

Record last verified: 2019-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)