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CTRI Number  CTRI/2023/08/056222 [Registered on: 07/08/2023] Trial Registered Prospectively
Last Modified On: 09/10/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A CLINICAL AND RADIOGRAPHIC EVALUATION OF THE MANAGEMENT OF PERIODONTAL FURCATION DEFECTS WITH BONE GRAFT AND TISSUE GRAFT FROM PALATE 
Scientific Title of Study   Comparative assessment of Clinical and Radiographic outcomes of Sticky Bone alone and Sticky Bone with Connective Tissue Graft in treatment of Grade II Furcation defects in Mandibular Molars 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR Rupali Saroshe 
Designation  PG Student 
Affiliation  Government college of dentistry 
Address  Room number 10 Department of periodontics Government college of dentistry Sardar patel marg INDORE

Indore
MADHYA PRADESH
452001
India 
Phone  09893437552  
Fax    
Email  drrupalisaroshe1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR Madhu S Ratre 
Designation  Professor and Head of the Department 
Affiliation  Government college of dentistry 
Address  Room number 10 Department of periodontics Government college of dentistry Sardar patel marg Indore
67,sanjana park ,indore
Indore
MADHYA PRADESH
452001
India 
Phone  09406928976  
Fax    
Email  smadhu16feb@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  DR Rupali Saroshe 
Designation  PG Student 
Affiliation  Government college of dentistry 
Address  Room number 10 Department of periodontics Government college ofdentistry Sardar patel marg Indore

Indore
MADHYA PRADESH
452001
India 
Phone  9893437552  
Fax    
Email  drrupalisaroshe1@gmail.com  
 
Source of Monetary or Material Support  
GOVT. DENTAL COLLEGE INDORE ROOM NUMBER10 DEPARTMENT OF PERIODONTOLOGY OPPOSITE MY HOSPITAL SARDAR PATEL MARG INDORE 
 
Primary Sponsor  
Name  GOVERNMENT COLLEGE OF DENTISTRY 
Address  ROOM NO 10 DEPT OFPERIODONTICS GOVT DENTAL COLLEGE SARGARPATEL MARG INDORE M.P 452001 
Type of Sponsor  Government medical college 
 
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 Rupali Saroshe  Government college of dentistry  Room number 10 Department of periodontics
Indore
MADHYA PRADESH 		 09893437552

drrupalisaroshe1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Government College of Dentistry, Indore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  furcation grade 2 periodontal defects 
Patients  (1) ICD-10 Condition: K055||Other periodontal diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Treatment of mandibular GRADE II furcation defect with bone graft and i-PRF mixture (sticky bone)  Treatment of mandibular GRADE II furcation defect with bone graft and i-PRF mixture (sticky bone) clinical parameters will be recorded at baseline T0 and t1 after 6 months of procedure  
Comparator Agent  treatment of mandibular grade II furcation defect using bone graft and i-PRf( sticky bone ) with connective tissue graft  treatment of mandibular grade II furcation defect using bone graft and i-PRf( sticky bone ) with connective tissue graft. clinical parameters will be recorded at baseline T0 and t1 after 6 months of procedure 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Systemically healthy male or female patients aged between 18 years to 60 years who are willing to give their consent
Patient with at least one mandibular molar tooth with grade II furcation defect
Patients having vertical probing pocket depth (PPD) ≥5 mm, and ≥3 mm of horizontal probing depth but not entirely through furcation
Patients willing to follow recommended plaque control and follow up regimen
Patients having no history of any medication affecting periodontal healing
 
 
ExclusionCriteria 
Details  History of systemic diseases like diabetes mellitus, hypertension,chronic obstructive pulmonary diseases.
Patients with other types of furcation defects like grade I, III and IV.
Patients with grade 2 or 3 tooth mobility in molars.
Patients with severe cervical abrasion ,root caries, vertical bone loss and tooth mobility.
Smokers and tobacco users
Patients with poor oral hygiene
Pregnant and lactating women
Psychiatric illness
Unwillingness to return for the follow-up
 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
To evaluate the effectiveness of combination of autogenous connective tissue graft with sticky bone in comparison to sticky bone alone in treatment of grade II furcation defects in mandibular molars  BASELINE AND 6 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
1.To evaluate and compare the soft tissue thickness of gingiva postoperatively around the treated sites.
2 To evaluate and compare the position of marginal gingiva postoperatively around the treated sites
 		 BASELINE AND 6 MONTHS 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 2/ Phase 3 
Date of First Enrollment (India)   10/08/2023 
Date of Study Completion (India) 10/08/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="10" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
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 - All of the individual participant data collected during the trial, after de-identification.

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

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

  4. For what types of analyses will this data be available?
    Response - Any purpose.

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

  6. For how long will this data be available start date provided 01-04-2024 and end date provided 01-04-2030?
    Response - Immediately following publication. No end date.

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

·         Selection of patients with Grade II furcation defects in molars and their random allocation to 2 different groups.

·         After adequate local anesthesia, a full-thickness mucoperiosteal flaps will be raised around the grade 2 furcation defect to expose the defect. The defects will be randomly assigned to one of the following treatment modalities at the time of surgery:

Group 1 (test group)    -   connective tissue graft + i-PRF + perioglass  (sticky bone graft) 

Group 2 (control group)  - i-PRF + perioglas  (sticky bone graft)

In group 1 patients, the furcation defect will be filled with sticky bone (i-PRF and bone graft perioglas.

·   In group 2 patients ,the furcation defect will be filled first with sticky bone (i-PRF and bone graft (perioglas)  then sub epithelial  connective tissue graft obtained from palate will  then be deposed over the defect.

·  Injectable Platelet Rich Fibrin (i-PRF) will be prepared from patient’s own blood centrifuged at 700 rpm for 3 min. Then bone graft granules will be mixed with it to obtain sticky bone.

·  Patient will be evaluated after 6 months post-operatively.

 

 
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