FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2018/01/011301 [Registered on: 12/01/2018] Trial Registered Retrospectively
Last Modified On: 23/12/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of two grafts ,Platelet Rich Fibrin Plug Vs Biphasic Calcium Phosphate in the Treatment of Chronic Periodontitis Patients 
Scientific Title of Study   Comparative Clinical and Radiographic Evaluation of Platelet Rich Fibrin Plug Vs Biphasic Calcium Phosphate (SybografTM - Plus) as Grafts in the Treatment of Infrabony Defects in Chronic Periodontitis Patients 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Parkavi A 
Designation  First year postgraduate student 
Affiliation  Nair Hospital Dental College 
Address  202, Department of Periodontics, Nair Hospital Dental College, Mumbai Central.

Mumbai
MAHARASHTRA
400008
India 
Phone  9619307113  
Fax    
Email  drparx1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mala Dixit Baburaj 
Designation  Professor and Head of the Department 
Affiliation  Nair Hospital Dental College 
Address  202, Department of Periodontics, Nair Hospital Dental College, Mumbai Central.

Mumbai
MAHARASHTRA
400008
India 
Phone  9223340938  
Fax    
Email  maladixit25@gmail.com  
 
Details of Contact Person
Public Query  
Name  Parkavi A 
Designation  First year postgraduate student 
Affiliation  Nair Hospital Dental College 
Address  202, Department of Periodontics, Nair Hospital Dental College, Mumbai Central.

Mumbai
MAHARASHTRA
400008
India 
Phone  9619307113  
Fax    
Email  drparx1@gmail.com  
 
Source of Monetary or Material Support  
Nair Hospital Dental College, Mumbai. 
 
Primary Sponsor  
Name  Parkavi A 
Address  202, Department of Periodontics, Nair Hospital Dental College, Mumbai Central - 400008. 
Type of Sponsor  Other [Parkavi A] 
 
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 
Parkavi A  Nair Hospital Dental College, Mumbai.  Room No: 202, Second floor, Department of Periodontics, Nair Hospital Dental College, Mumbai Central - 400008.
Mumbai
MAHARASHTRA 		 9619307113

drparx1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
MAHARASHTRA UNIVERSITY OF HEALTH SCIENCES  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Chronic Periodontitis patients with interproximal bone defects of 5 mm or more.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  biphasic calcium phosphate graft   comercially available biphasic calcium phosphate graft (SybografTM - plus) 
Intervention  Platelet rich fibrin plug  platelet rich fibrin plug obtained from the patients own blood. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Age group between 20-60years
2. Diagnosis with chronic periodontitis
3. Patients in good systemic health with no contraindication to periodontal surgery
4. Patients having infrabony defects with pocket depths of 5mm or more and with radiographic evidence of vertical or angular bone loss in the affected sites.
5. Involved teeth to be vital and asymptomatic
 
 
ExclusionCriteria 
Details  1. One — wall osseous defects.
2. Patients suffering from any systemic diseases or with compromised immune system.
3. Patients who had received any type of periodontal therapy for the past 6 months
4. Patients taking any immuno-suppressive drugs like corticosteroids
5. Patients with a known history of allergy to doxycycline or Chlorhexidine or any other
medicine be used in the study.
6. Patients showing unacceptable oral hygiene compliance during / after the phase I therapy. 7. Patients taking any drug known to cause gingival enlargement.
8. Pregnant and/or lactating mothers.
9. Patients who were smokers or had tobacco in any other form.
10. Endodontically treated teeth.
11. Patient on anticoagulant therapy
12. Patient with bleeding disorders.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Plaque Index (P.I.) (TURSKEY-GILMORE-GLICKMAN MODIFICATION OF QUIGLEY HEIN).
2. Gingival Index (G.I.) (LOE &SILNESS, 1963).
3. Probing Pocket Depth (PPD).
4. Clinical Attachment Level (CAL).

 		 1.Plaque Index (P.I.) (TURSKEY-GILMORE-GLICKMAN MODIFICATION OF QUIGLEY HEIN).
2. Gingival Index (G.I.) (LOE &SILNESS, 1963).
Plaque and Gingival index will be measured at baseline, 1 month, 3 month and 6 month post-operatively.
3. Probing Pocket Depth (PPD).
4. Clinical Attachment Level (CAL).
Probing Pocket Depth and Clinical Attachment Level will be measured at baseline, 3 month and 6 month post-operatively.
 
 
Secondary Outcome  
Outcome  TimePoints 
Radiographic bone fill will be evaluated using inta oral periapical radiographs of the surgical site.  radiographs will be taken at baseline, immediately post surgery and at sixth month post surgery. 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   N/A 
Date of First Enrollment (India)   05/12/2016 
Date of Study Completion (India) 15/01/2018 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 15/01/2018 
Estimated Duration of Trial   Years="1"
Months="8"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  		 The aim of the study is to evaluate and compare clinically and radiographically the effect of platelet rich fibrin plug vs biphasic calcium phosphate (SybografTM - Plus) as grafts in the treatment of infrabony defects in chronic periodontitis patients. A total of 40 patients with chronic periodontitis will be selected from the outpatient department of Periodontics, Nair Hospital Dental College, Mumbai and will be equally divided into two groups of 20 each. In Group A platelet rich fibrin plug and in Group B biphasic calcium phosphate (SybografTM - Plus) will be placed as graft in interproximal bone defects. the study is clinical interventional prospective study. computer randomization method will be used as sampling method. The duration of the study is 20 months which includes a duration of 14 months for treatment procedures and 6 months for follow up. the primary efficacy parameters are plaque index, gingival index, probing pocket depth and clinical attachment level. Plaque and gingival index will be recorded at baseline, 1month, 3months and 6 months post surgery. Probing pocket depth and clinical attachment level will be recorded at baseline, 3 months and 6 months post surgery. radiographic analysis of the surgical site will be done to measure bone fill at baseline, immediately post surgery and 6 months post surgery. The data will be analysed individually for all the patients. the values will be subjected to comparison within and between groups using paired and upaired Student’s t test. There is no conflict of interest. 
Close