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CTRI Number  CTRI/2020/03/024346 [Registered on: 30/03/2020] Trial Registered Prospectively
Last Modified On: 26/03/2020
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   This is an interventional study to assess and compare Semaphorin 4D, Peptidylarginine Deiminase 2 and Matrix Metalloproteinase-8 in Gingival crevicular fluid levels before and after Non-surgical periodontal therapy in periodontally healthy, Severe periodontitis Smoker and non-smoker patients.  
Scientific Title of Study   Comparative evaluation of Semaphorin 4D, Peptidylarginine Deiminase 2 and Matrix Metalloproteinase-8 Gingival crevicular fluid levels in periodontally healthy, Severe periodontitis Smoker and non-smoker patients before and after Non-surgical periodontal therapy. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aishwarya Ikhar 
Designation  Post Graduate Student 
Affiliation  VSPM Dental College and Research Centre, Digdoh Hills, Nagpur. 
Address  104, Department of Periodontics and Implantology, VSPM Dental College and Research Centre, Digdoh Hills
104, Department of Periodontics and Implantology, VSPM Dental College and Research Centre, Digdoh Hills 440019
Nagpur
MAHARASHTRA
440019
India 
Phone  9011388274  
Fax  665011  
Email  ikharaishwarya@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Rajashri Kolte  
Designation  Professor and Guide 
Affiliation  VSPM Dental College and Research Centre, Digdoh Hills, Nagpur. 
Address  104, Department of Periodontics and Implantology, VSPM Dental College and Research Centre, Digdoh Hills
104, Department of Periodontics and Implantology, VSPM Dental College and Research Centre, Digdoh Hills 440019
Nagpur
MAHARASHTRA
440019
India 
Phone  9011071468  
Fax  665011  
Email  drrajashrikolte@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Abhay Kolte  
Designation  Professor and Head 
Affiliation  VSPM Dental College and Research Centre, Digdoh Hills, Nagpur. 
Address  104, Department of Periodontics and Implantology, VSPM Dental College and Research Centre, Digdoh Hills
104, Department of Periodontics and Implantology, VSPM Dental College and Research Centre, Digdoh Hills 440019
Nagpur
MAHARASHTRA
440019
India 
Phone  9011071467  
Fax  665011  
Email  drabhaypkolte@gmail.com  
 
Source of Monetary or Material Support  
None 
 
Primary Sponsor  
Name  Dr Aishwarya Ikhar 
Address  104, Department of Periodontics and Implantology VSPM Dental College and Research Centre Digdoh Hills, Hingna road Nagpur 440019  
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
None  None 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aishwarya Ikhar  VSPM Dental College and Research Centre   104, Department of Periodontics and Implantology, VSPM Dental College and Research Centre Digdoh Hills, Hingna road Nagpur 440019
Nagpur
MAHARASHTRA 		 9011388274

ikharaishwarya@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
VSPM Dental College and Research Centre Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Non Surgical Periodontal Therapy  The Semaphorin 4D, Peptidylarginine Deiminase 2 and Matrix Metalloproteinase-8 Gingival crevicular fluid levels will be compared in periodontally healthy, Severe periodontitis Smoker and non-smoker patients before and after Non-surgical periodontal therapy. 
Comparator Agent  Semaphorin 4D, Peptidylarginine Deiminase 2 and Matrix Metalloproteinase-8 Gingival crevicular fluid levels   The Semaphorin 4D, Peptidylarginine Deiminase 2 and Matrix Metalloproteinase-8 Gingival crevicular fluid levels will be compared in periodontally healthy, Severe periodontitis Smoker and non-smoker patients before and after Non-surgical periodontal therapy. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Group I: Periodontally healthy patients.
Group II: Non-Smoker patients with untreated stage III periodontitis, with PPD more than equal to 5 mm and CAL more than equal to 4mm, BOP at >50% of sites (full mouth) and radiographic evidence of interproximal bone loss.
Group III: Smoker patients with untreated stage III periodontitis, with PPD more than equal to 5 mm and CAL more than equal to 4mm, BOP at >50% of sites (full mouth) and radiographic evidence of interproximal bone loss.

 
 
ExclusionCriteria 
Details  1. Patients who had received periodontal treatment within the last 6 months.
2. Patients with any systemic diseases.
3. Patients who had or are on immunosuppressive chemotherapy.
4. Use of antibiotics within the last 6 months and anti-inflammatory drugs within the last 3 months.
5. Pregnant and lactating females. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the Semaphorin 4D, Peptidylarginine Deiminase 2 and Matrix Metalloproteinase-8 Gingival crevicular fluid levels in periodontally healthy, Severe periodontitis Smoker and non-smoker patients before and after Non-surgical periodontal therapy.  18 months 
 
Secondary Outcome  
Outcome  TimePoints 
To evaluate and compare the Semaphorin 4D, Peptidylarginine Deiminase 2 and Matrix Metalloproteinase-8 Gingival crevicular fluid levels in periodontally healthy, Severe periodontitis Smoker and non-smoker patients before and after Non-surgical periodontal therapy.  18 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" 
Phase of Trial   N/A 
Date of First Enrollment (India)   31/03/2020 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   NIL 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

Study is conducted to evaluate and compare the Semaphorin 4D, Peptidylarginine Deiminase 2 and Matrix Metalloproteinase-8 Gingival crevicular fluid levels in periodontally healthy, Severe periodontitis Smoker and non-smoker patients before and after Non-surgical periodontal therapy.

Group I:  20 Periodontally Healthy patients.

Group II: 20 Non -Smoker Patients with stage III periodontitis.

Group III: 20 Smoker Patients with stage III periodontitis.

The primary outcome will be to evaluate the Semaphorin 4D, Peptidylarginine Deiminase 2 and Matrix Metalloproteinase-8 Gingival crevicular fluid levels in periodontally healthy, Severe periodontitis Smoker and non-smoker patients before and after Non-surgical periodontal therapy.

The secondary outcome will be to evaluate and compare the Semaphorin 4D, Peptidylarginine Deiminase 2 and Matrix Metalloproteinase-8 Gingival crevicular fluid levels in periodontally healthy, Severe periodontitis Smoker and non-smoker patients before and after Non-surgical periodontal therapy.

A brief description of entire procedure will be given to every patient before starting procedure. Written informed consent will be taken from the patients who wish to enroll in the study.

Samples of Semaphorin 4D, Peptidylarginine Deiminase 2 and Matrix Metalloproteinase-8 Gingival crevicular fluid in periodontally healthy, Severe periodontitis Smoker and non-smoker patients before and after Non-surgical periodontal therapy will be collected. Clinical and biochemical parameters will then be evaluated.

METHODS OF MEASUREMENT

 Biochemical parameters:

Semaphorin 4D, Peptidylarginine Deiminase 2 and Matrix Metalloproteinase-8 Gingival crevicular fluid levels will be measured using Enzyme Linked Immunosorbent Assay (ELISA) kits.

 For all participants following periodontal parameters will be recorded:

1.  Gingival index (Loe and Silness 1963)

2.  Plaque index (Silness and Loe 1964)

3.  Papillary bleeding index (PBI) (Muhlemann H.R. 1977)

4.  Probing pocket depth (PPD)

5.  Clinical attachment level (CAL)

After clinical examination, Gingival Crevicular fluid samples would be collected and Semaphorin 4D, Peptidylarginine Deiminase 2 and Matrix Metalloproteinase-8 levels will be evaluated using Enzyme Linked Immunosorbent Assay kit.

Non-surgical periodontal therapy will be performed at baseline at after 3 months. 
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