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CTRI Number  CTRI/2021/07/035236 [Registered on: 29/07/2021] Trial Registered Prospectively
Last Modified On: 28/07/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   To compare and evaluate the effectiveness of PRF with or without Osseograft in the treatment of intrabony defects in chronic periodontitis patients. 
Scientific Title of Study   “Comparative Clinical and Radiographic Evaluation of the Effectiveness of Bovine Derived Xenograft (OsseograftTM/DMBM) Alone and a Combination of Bovine Derived Xenograft and Autologous Advanced PRF (A-PRF+) in the Treatment of Intrabony Defects in Chronic Periodontitis Patients –A Randomized Clinical Trial.” 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Lishana Farnomi Ch Momin 
Designation  First Year Post Graduate MDS, Department of Periodontics 
Affiliation  NAIR HOSPITAL DENTAL COLLEGE MUMBAI 
Address  Room no.201, Department of Periodontics Nair Hospital Dental College,Mumbai Maharashtra, India 400008
Room no.201,Department of Periodontics Nair Hospital Dental College,Mumbai Maharashtra, India 400008
Mumbai
MAHARASHTRA
400008
India 
Phone  8259890492  
Fax    
Email  cheranlishana@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Praneeta Kamble 
Designation  Associate Professor 
Affiliation  Nair Hospital Dental College,Mumbai,400008,Maharashtra, India 
Address  201 Department of Periodontics Nair Hospital Dental College,Mumbai Maharashtra, India 400008

Mumbai
MAHARASHTRA
400008
India 
Phone  9820263468  
Fax    
Email  drpraneetakamble@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Praneeta Kamble 
Designation  Associate Professor 
Affiliation  Nair Hospital Dental College,Mumbai,400008,Maharashtra, India 
Address  201 Department of Periodontics Nair Hospital Dental College,Mumbai Maharashtra, India 400008

Mumbai
MAHARASHTRA
400008
India 
Phone  9820263468  
Fax    
Email  drpraneetakamble@gmail.com  
 
Source of Monetary or Material Support  
Dr. Lishana Farnomi Ch Momin Room no. 201, Nair Hospital Dental College, Mumbai, 400008, Maharashtra, India 
 
Primary Sponsor  
Name  Lishana Farnomi Ch Momin 
Address  Room no. 1302, G-Wing, Sukharta building behind one avighna park, currey road bridge, lower parel, Mumbai 400012 
Type of Sponsor  Other [(1st year post graduate student )] 
 
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 
Lishana Farnomi Ch Momin  Lishana Farnomi Ch Momin  Room 201, department of Periodontics, second floor, Nair Hospital Dental College, Mumbai Central 400008, Mumbai Maharashtra
Mumbai
MAHARASHTRA 		 8787681838

cheranlishana@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee Nair Hospital Dental College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 8||Other Procedures,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Bovine Derived Xenograft   Commercially available as Osseograft TM 
Comparator Agent  Bovine Derived Xenograft with A-PRF  Bovine Derived Xenograft with A-PRF+ 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patient in the age group between 30-60 years.
2. Patient diagnosed with Chronic Periodontitis.
3. Patient who are non smokers and do not consume tobacco in any form.
4. Patients in good systemic health with no contraindications to periodontal surgery.
5. Patients having pocket depth greater than 5mm, intraosseous defects greater than 3mm with radiographic evidence of vertical or angular bone loss in the affected sites.
6. Involved teeth should be vital and asymptomatic.
 
 
ExclusionCriteria 
Details  1.) One-walled osseous defects.
2) Patients suffering from any systemic diseases judge to impair normal healing and immune-compromised patients.
3) Patients who had received any type of periodontal therapy for the past 6 months.
4) Patients taking immunosuppressant drugs like corticosteroids.
5) Patients with a known history of allergy to Doxycycline or Chlorhexidine or any other medicine used in the study.
6) Patients taking any drug known to cause gingival enlargement.
7) Pregnant or lactating mothers.
8) Patients who were smokers or had tobacco in any other form.
9) Patients on anticoagulant therapy.
 
 
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.) (Tureskey-Gilmore-Glickman Modification of Quigley Hein).
2. Gingival Index (G.I.) (Loe and Silness, 1963)
3. Probing Pocket Depth (PPD)
4. Clinical Attachment Level (CAL)

 
At Baseline
After 1 month
After 3 month
After 6 month
 
 
Secondary Outcome  
Outcome  TimePoints 
The radiographic bone fill will be evaluated using Intraoral Periapical Radiographs of the surgical site  Baseline-at baseline. immediately after the surgery and 6 month post-surgery 
 
Target Sample Size   Total Sample Size="40"
Sample Size from India="40" 
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)   03/08/2021 
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="1"
Months="8"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) - 

  6. For how long will this data be available start date provided 28-07-2021 and end date provided 28-05-2022?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

Aims and objectives :

To  compare and evaluate  the effectiveness of Autologous Advanced PRF(A-PRF) with or without  Bovine Derived Xenograft (Osseograft TM)  in the treatment of intrabony defects in Chronic Periodontitis patients based on cliinical and radiographic  parameters.


Materials and methods:

Fourty intrabony defects in which 40 patients were randomly divided into two different groups and were treated with group A (Ossegraft alone) and group B (Osseograft with A-PRF). Clinical parameters such as plaque index (PI), gingival index (GI), pocket probing depth (PPD), clinical attachment level (CAL) were assessed at baseline 1 month, 3 month and 6 month postoperatively; radiographic parameter such as percentage in bone fill (%BF) were calculated by using the computerized image analysis software. 

Data collected will be entered into a computer and analyzed using the SPSS (Statistical Package for the Social Sciences) software. Results on continuous measurements will be presented on Mean ± SD and results on categorical measurements will be presented in Number (%). 

Chi square analysis will be used to find the significance of study parameters on categorical scale. Student t test (two tailed, independent) will be used to find the significance of study parameters on continuous scale within and between two groups (Intra and Inter group analysis) on metric parameters.




 
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