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CTRI Number  CTRI/2017/11/010370 [Registered on: 03/11/2017] Trial Registered Retrospectively
Last Modified On: 03/11/2017
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Evaluation of the efficacy of 1% Alendronate Gel with Platelet Rich Fibrin in Grade II Furcation Defects in Chronic Periodontitis. 
Scientific Title of Study   Comparative Evaluation of 1% Alendronate Gel in Combination with Platelet Rich Fibrin and Platelet Rich Fibrin Alone in the Treatment of Grade II Furcation Defects in Chronic Periodontitis by CBCT: A Clinico-radiographic Study 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Ishita Wanikar 
Designation  Post Graduate student 
Affiliation  VSPM Dental College and Research Centre 
Address  Department of Periodontics and Implantology VSPM Dental College and Research Centre Digdoh Hills Hingna Road Nagpur Maharashtra India

Nagpur
MAHARASHTRA
440019
India 
Phone  7208470955  
Fax    
Email  drishitawanikar@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Surekha Rathod 
Designation  Professor and Guide 
Affiliation  VSPM Dental College and Research Centre 
Address  Department of Periodontics and Implantology VSPM Dental College and Research Centre Digdoh Hills Hingna Road Nagpur Maharashtra India

Nagpur
MAHARASHTRA
440019
India 
Phone  9011071477  
Fax    
Email  drsurekhar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Surekha Rathod 
Designation  Professor and Guide 
Affiliation  VSPM Dental College and Research Centre 
Address  Department of Periodontics and Implantology VSPM Dental College and Research Centre Digdoh Hills Hingna Road Nagpur Maharashtra India

Nagpur
MAHARASHTRA
440019
India 
Phone  9011071477  
Fax    
Email  drsurekhar@gmail.com  
 
Source of Monetary or Material Support  
VSPM Dental College and REsearch Centre, Nagpur 
 
Primary Sponsor  
Name  Nil 
Address  Nil 
Type of Sponsor  Other [nil] 
 
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 Ishita Wanikar  VSPM Dental College and Research Centre  Department of Periodontics and Implantology, Room number 104, First floor, Digdoh Hills Hingna Road Nagpur 440019 Maharashtra India
Nagpur
MAHARASHTRA 		 7208470955

drishitawanikar@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  Chronic Periodontitis Patients,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  1% Alendronate Gel in Combination with Platelet Rich Fibrin and Platelet Rich Fibrin Alone in the Treatment of Grade II Furcation Defects in Chronic Periodontitis  The trial is an Interventional study in the treatment of chronic periodontitis comparing two different treatment modalities involving the placement of Platelet Rich Fibrin with and without 1% Alendronate gel in grade II furcation defects 
Intervention  Platelet Rich Fibrin in the Treatment of Grade II Furcation Defects in Chronic Periodontitis  The trial is an Interventional study in the treatment of chronic periodontitis comparing two different treatment modalities involving the placement of Platelet Rich Fibrin with and without 1% Alendronate gel in grade II furcation defects 
 
Inclusion Criteria  
Age From  22.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients with moderate to advanced periodontitis as assessed by probing pocket depth ≥ 5 mm and clinical attachment level ≥ 5 mm.

2. Patients with atleast one pair of bilateral grade II furcation defect in either maxillary or mandibular arch
 
 
ExclusionCriteria 
Details  1. Patients with history of systemic diseases, allergies or drug usage.

2. Patients who have undergone periodontal treatment in previous 6 months.

3. Pregnant and lactating mothers.
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded 
Primary Outcome  
Outcome  TimePoints 
Improvement in Periodontal Status i.e. reduction in Probing Pocket Depth, Gain in Clinical Attachment Level, Bone Fill in Furcation area (seen by advanced radiography i.e. CBCT)  3-6 months 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in Plaque scores and Gingival Bleeding scores representing improvement in Gingival (soft tissue) status, within 3-6 months  3-6 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   Phase 1/ Phase 2 
Date of First Enrollment (India)   01/08/2016 
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="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

This study is a Randomized, parallel group, active controlled clinical trial comparing the efficacy of 1% Alendronate gel with PRF and PRF  alone in 20 patients with chronic periodontitis exhibiting bilateral grade II furcation defects (20 sites for each group)  followed by re-evaluation at 3 and  6 months. The primary outcome measures will be improvement in patient’s periodontal status (reduced probing pocket depth, gain in clinical attachment level, and bone fill at periodontal furcation defects. The secondary outcomes will be reduction in patient’s plaque & gingival bleeding scores. 

 
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