ESTIMATION OF GINGIVAL CREVICULAR LEVEL OF YKL40

Sponsor

Krishnadevaraya College of Dental Sciences & Hospital (Other)

Overall Status

Unknown status

CT.gov ID

NCT03995615

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Periodontitis and Rheumatoid Arthritis	Procedure: scaling and root planing	N/A

Detailed Description

Periodontal diseases is a chronic inflammatory diseases initiated by microbial infection that leads to a host response resulting in inflammatory breakdown of tooth supporting, osseous and soft tissue structures YKL-40 also called as human cartilage glycoprotein-39(HC-gp39), an acute phase protein is a novel potential bio marker in relation to both acute and chronic inflammations. YKL-40 is a member of "mammalian chitinase- like protein" but has no chitinase/ enzymatic activity, with molecular weight of approximately 40KDa. It is named from three amino acids of Tyrosine (Y), Lysine (K) and leucin (L) at the N-terminal YKL-40 was identified in gingival crevicular fluid (GCF) and serum among gingivitis and periodontitis individual with or without diabetic mellitus. Investigation was done in association between chronic periodontitis and diabetic mellitus in gingival crevicular fluid sample. However, the past studies have reported an increased prevalence of rheumatoid arthritis in patient with periodontal diseases. They have reported the presence of rheumatoid factor in gingiva, sub gingival plaque, saliva and serum of periodontally diseased patient. Treatment of periodontal disease has demonstrated significant reduction in erythrocyte sedimentation rate (ESR) which in turn have showed improvement of clinical indices on rheumatoid arthritis activity.we speculate that 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 condition

Study Design

Study Type:

Interventional

Anticipated Enrollment :

45 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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 A Clinico-biochemical Study

Anticipated Study Start Date :

Jan 1, 2020

Anticipated Primary Completion Date :

Mar 1, 2020

Anticipated Study Completion Date :

Oct 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Group I (Control) • Group I (Control) - 15 periodontally healthy patient with probing depth< 3mm and ≤ 10% sites with bleeding on probing.
No Intervention: • Group II • 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
No Intervention: • Group III • 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
Active Comparator: • Group IV • 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 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

Outcome Measures

Primary Outcome Measures

levels of YKL40 IN GCF [6 WEEEKS]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

25 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

1. 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.

Exclusion Criteria:

1. 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Krishnadevaraya college of dental sciences	Bangalore	Karnataka	India	562157

Sponsors and Collaborators

Krishnadevaraya College of Dental Sciences & Hospital

Investigators

Principal Investigator: RUDRAKSHI C, MDS, Krishnadevaraya college of dental sciences , Banglore ,KARNATAKA , INDIA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr Prabhuji MLV, professor/ head of the department periodontology, Krishnadevaraya College of Dental Sciences & Hospital

ClinicalTrials.gov Identifier:

NCT03995615

Other Study ID Numbers:

02_D012_91499

First Posted:

Jun 24, 2019

Last Update Posted:

Jun 24, 2019

Last Verified:

Jun 1, 2019

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Arthritis

Arthritis, Rheumatoid

Periodontitis

Study Results

No Results Posted as of Jun 24, 2019