ESTIMATION OF GINGIVAL CREVICULAR LEVEL OF YKL40

Periodontitis and Rheumatoid Arthritis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03995615
• Other study ID #: 02_D012_91499
• Status: Recruiting
• Phase: N/A
• Start date: January 2020
• Est. completion date: October 2021

Study information

• Verified date: June 2019
• Source: Krishnadevaraya College of Dental Sciences & Hospital
• Contact: RUDRAKSHI C, MDS
• Phone: 28467083
• Email: drrudrakshi[@]rediffmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: October 2021
• Est. primary completion date: March 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Chronic Periodontitis
• Periodontitis
• Periodontitis and Rheumatoid Arthritis

Intervention

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

Locations

Country	Name	City	State
India	Krishnadevaraya college of dental sciences	Bangalore	Karnataka

Sponsors (1)

Lead Sponsor	Collaborator
Krishnadevaraya College of Dental Sciences & Hospital

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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