FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2021/02/031474 [Registered on: 23/02/2021] Trial Registered Prospectively
Last Modified On: 22/02/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia
Dentistry 
Study Design  Single Arm Study 
Public Title of Study   Evaluation of a biomarker levels(peptidyl arginine dieminase 2) in patients with severe gum disease before and after professional cleaning of tooth and root surface and after gum surgery. 
Scientific Title of Study   “COMPARATIVE EVALUATION OF PEPTIDYLARGININE DEIMINASE 2 LEVELS IN GINGIVAL CREVICULAR FLUID OF PATIENTS WITH CHRONIC PERIODONTITIS BEFORE AND AFTER SCALING AND ROOT PLANING AND FLAP SURGERY- A CLINICO BIOCHEMICAL STUDY ’’ 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Abhiraami 
Designation  Postgraduate student 
Affiliation  coorg institute of dental sciences 
Address  Department of Periodontics and implantology room no 4 Coorg Institute of dental sciences Kk campus maggula village virajpet kodagu

Kodagu
KARNATAKA
571218
India 
Phone  09483429573  
Fax    
Email  abhiraami.shaji@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Abhiraami 
Designation  Postgraduate student 
Affiliation  coorg institute of dental sciences 
Address  Coorg Institute of dental sciences Department of periodontics and implantology room no 4 Kk campus maggula village virajpet kodagu

Kodagu
KARNATAKA
571218
India 
Phone  09483429573  
Fax    
Email  abhiraami.shaji@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Amit Walvekar 
Designation  Head of the department and professor 
Affiliation  Coorg institute of dental sciences 
Address  Coorg Institute of dental sciences Department of periodontics and implantology room no 4 Kk campus maggula village virajpet kodagu

Kodagu
KARNATAKA
571218
India 
Phone  9480085687  
Fax    
Email  amitakw@rediffmail.com  
 
Source of Monetary or Material Support  
Coorg institute of dental sciences 
 
Primary Sponsor  
Name  Abhiraami 
Address  coorg institute of dental sciences kk campus maggula virajpet karnataka 571218 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Abhiraami  Coorg institute of dental sciences  Coorg Institute of dental sciencesDepartment of periodontics and implantology room no 4 Kk campus maggula village Virajpet kodagu
Kodagu
KARNATAKA 
919483429573

abhiraami.shaji@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional review board  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  chronic periodontitis 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  flap surgery  flap surgery is done two weeks after scaling and rootplaning  
Comparator Agent  not applicable  not applicable 
Intervention  Scaling and rootplaning   scaling and rootplaning is done in the first appointment 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details 
Subjects with a minimum complement of 20 teeth.
Subjects with chronic periodontitis indicated for flap surgery.

 
 
ExclusionCriteria 
Details  Subjects with any systemic disease.
Subjects who have undergone any periodontal treatment in the last 6 months.
Subjects who have received antibiotics/anti-inflammatory drugs/steroids immunosuppressive chemotherapy within the last 6 months.
 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
reduction of clinical parameters and reduction of PEPTIDYLARGININE DEIMINASE 2   reduction of clinical parameters and reduction of PEPTIDYLARGININE DEIMINASE 2 from baseline to 2 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
gradual reduction of clinical parameters and gradual reduction of PEPTIDYLARGININE DEIMINASE 2   gradual reduction of clinical parameters and gradual reduction of PEPTIDYLARGININE DEIMINASE 2 from baseline to two months  
 
Target Sample Size   Total Sample Size="20"
Sample Size from India="20" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   23/02/2021 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   nil 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Periodontal diseases are a group of infectious/inflammatory diseases of tooth supporting tissues initiated by putatively virulent microorganisms in the microbial dental plaque.1 Periodontal tissue destruction derives from a direct effect of the bacterial toxic substances and from the action of the immune system activated by the bacterial infection.2 For an accurate diagnosis and a treatment choice, a reliable evaluation of periodontal inflammation is important.

The peptidylarginine deiminases (PADs) are a family of enzymes capable of converting amino acid arginine into citrulline a process known as citrullination.4 Citrullination is related to various physiological processes such as skin keratinization and gene regulation for immune functions, and also plays role in autoimmune diseases and inflammatory conditions.4.5   Antibodies produced against citrullinated proteins are called anti-citrullinated protein antibodies (ACPAs).5  It has been hypothesized that periodontitis may be a stimulator for ACPA formation.6 In addition, in vitro studies have shown that one of the periodontal pathogens, Porphyromonas gingivalis, produces a variant of PAD (sometimes referred to as P. gingivalis PAD or PPAD), which is capable of citrullinating proteins.7 Studies have reported that increased expression of PAD2 in gingival connective tissue of patients with periodontitis compared to periodontal healthy group.8 Therefore peptidylarginine deiminases can be used as a biomarker for the evaluation of periodontal disease.

This study is aimed at comparing levels of PAD2 in gingival crevicular fluid of chronic periodontitis patients with before and after scaling and rootplaning alone and as an adjunct to scaling and root planing and flap surgery.

 
Close