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
|
|
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
|
|
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. |