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CTRI Number  CTRI/2023/07/054656 [Registered on: 03/07/2023] Trial Registered Prospectively
Last Modified On: 10/06/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Comparison of vitamin C plus blood protein derivative & blood protein derivative in treatment of bone loss seen in posterior teeth 
Scientific Title of Study   Comparative evaluation of clinical and radiographic effects of ascorbic acid augmented platelet rich fibrin versus platelet rich fibrin alone in the treatment of Grade II furcation involvement: A randomised controlled study. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Tusharika Sharma 
Designation  Postgraduate Student 
Affiliation  KM SHAH DENTAL COLLEGE AND HOSPITAL  
Address  ROOM NO 7 DEPARTMENT OF PERIODONTOLOGY

Vadodara
GUJARAT
391760
India 
Phone  8082864187  
Fax    
Email  tusharika4064@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Neeraj Deshpande 
Designation  Professor And PG Guide 
Affiliation  KM SHAH DENTAL COLLEGE AND HOSPITAL 
Address  ROOM NO 7 DEPARTMENT OF PERIODONTOLOGY

Vadodara
GUJARAT
391760
India 
Phone  7600918500  
Fax    
Email  drneeraj78@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Neeraj Deshpande 
Designation  Professor And PG Guide 
Affiliation  KM SHAH DENTAL COLLEGE AND HOSPITAL  
Address  ROOM NO 7 DEPARTMENT OF PERIODONTOLOGY


GUJARAT
391760
India 
Phone  7600918500  
Fax    
Email  drneeraj78@gmail.com  
 
Source of Monetary or Material Support  
KM SHAH DENTAL COLLEGE, SUMANDEEP VIDYAPEETH, VADODARA, GUJARAT 
 
Primary Sponsor  
Name  DR TUSHARIKA SHARMA 
Address  Room No 7 Department Of Periodontology KM Shah Dental College, Vadodara, Gujarat 
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 Tusharika Sharma  Km Shah Dental College  Room No 7 Department Of Periodontology
Vadodara
GUJARAT 
8082864187

tusharika4064@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
SUMANDEEP VIDYAPEETH INSTITUTIONAL 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  Open flap debridement with Ascorbic Acid and Platelet rich fibrin   In grade II furcation open flap debridement will be done with platelet rich fibrin augmented ascorbic acid and outcome will be assessed at 3 months and 6 months. 
Comparator Agent  open flap debridement with platelet rich fibrin  In grade II furcation open flap debridement will be done with platelet rich fibrin 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Age group between twenty five years to sixty years
Willing to participate in study.
Availability for follow-up appointments
Patients with mandibular molars and grade II furcation.
Clinical attachment loss more than or equal to 5 mm
Probing depth more than or equal to 6 mm
Radiographic intraosseous defect more than or equal to 3 mm
Systemically healthy 
 
ExclusionCriteria 
Details  Pregnant or lactating mothers.
Patients with known systemic disease or blood dyscrasias or on any
medication known to interfere with outcomes of periodontal therapy.
Current smokers, tobacco chewers and alcoholic patients.
Previously treated for periodontal disease within 6 months. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Participant and Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
Radiographic bone level,
Radiographic bone defect fill percentage 
Baseline
3 Months
6 Months 
 
Secondary Outcome  
Outcome  TimePoints 
Probing Pocket Depth,
Plaque index,
Gingival Marginal Level(GML),
Clinical Attachment Level (CAL) 
Baseline
3 Months
6 Months 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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   Phase 4 
Date of First Enrollment (India)   07/08/2023 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Periodontitis is an inflammatory destructive disorder of the periodontal supporting structures, which is associated with microbial dysbiosis. Its primary features include the loss of periodontal tissue support , manifested through clinical  attachment loss , presence of periodontal pocket and radiographically alveolar  bone loss. The goal  of  regenerative periodontal therapy, is to restore the tooth supporting apparatus that has benn lost due to periodontal disease or injury . PRF is classified as a second generation platelet concentrate, as it is prepared as a natural concentrate without the addition of any anticoagulants. Platelet rich fibrin  is an easily prepared , autologous natural scaffold  harbouring a multitude of growth /differentiation factor. Vitamin C may lower the risk of periodontal diseases and even facilitate  healing  of the periodontium due to its strong antioxidant capacity that allows it to inactivate ROS that  damage structure and function of tissues.Surgical procedure is done after presurgical treatment ,that is scaling and root planning. After oral prophylaxis is done , 1 week follow up is done . After 1 week clinical parameters to be evaluated and surgery is performed in which OFD  with PRF  is done on one side and on the other side OFD  alongwith  ascorbic acid and PRF is injected on other side. Then flaps are approximated and then sutured . After that clinical and radiographic parameters are evaluated at 3 months and 6 months.

 
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