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ESTIMATION OF GINGIVAL CREVICULAR LEVEL OF YKL40

Primary Purpose

Periodontitis and Rheumatoid Arthritis

Status
Unknown status
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
scaling and root planing
Sponsored by
Krishnadevaraya College of Dental Sciences & Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Periodontitis and Rheumatoid Arthritis

Eligibility Criteria

25 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Krishnadevaraya college of dental sciencesRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

No Intervention

No Intervention

Active Comparator

Arm Label

Group I (Control)

• Group II

• Group III

• Group IV

Arm Description

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

• 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 - 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Full Information

First Posted
June 20, 2019
Last Updated
June 20, 2019
Sponsor
Krishnadevaraya College of Dental Sciences & Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03995615
Brief Title
ESTIMATION OF GINGIVAL CREVICULAR LEVEL OF YKL40
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2020 (Anticipated)
Primary Completion Date
March 2020 (Anticipated)
Study Completion Date
October 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Krishnadevaraya College of Dental Sciences & Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis and Rheumatoid Arthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantOutcomes Assessor
Allocation
Non-Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group I (Control)
Arm Type
No Intervention
Arm Description
• Group I (Control) - 15 periodontally healthy patient with probing depth< 3mm and ≤ 10% sites with bleeding on probing.
Arm Title
• Group II
Arm Type
No Intervention
Arm Description
• 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
Arm Title
• Group III
Arm Type
No Intervention
Arm Description
• 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
Arm Title
• Group IV
Arm Type
Active Comparator
Arm Description
• 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
Intervention Type
Procedure
Intervention Name(s)
scaling and root planing
Intervention Description
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
Primary Outcome Measure Information:
Title
levels of YKL40 IN GCF
Description
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
Time Frame
6 WEEEKS

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
RUDRAKSHI C, MDS
Phone
28467083
Ext
080
Email
drrudrakshi@rediffmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
RUDRAKSHI C, MDS
Organizational Affiliation
Krishnadevaraya college of dental sciences , Banglore ,KARNATAKA , INDIA
Official's Role
Principal Investigator
Facility Information:
Facility Name
Krishnadevaraya college of dental sciences
City
Bangalore
State/Province
Karnataka
ZIP/Postal Code
562157
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MLV Prabhuji
Phone
+919448057407
Email
mlvprabhuji@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD are personal informations of patients and its confidential .

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ESTIMATION OF GINGIVAL CREVICULAR LEVEL OF YKL40

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