FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2024/04/065200 [Registered on: 04/04/2024] Trial Registered Prospectively
Last Modified On: 04/03/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Periodontal regeneration in infrabony defects 
Scientific Title of Study   “Comparative evaluation of the effectiveness of bioresorbable collagen membrane in combination with deproteinized bovine bone matrix xenograft and advanced platelet rich fibrin membrane in combination with deproteinized bovine bone matrix xenograft for periodontal regeneration in human infrabony defects: A clinical and 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  Shweta Bhagat 
Designation  PG student 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of Periodontics and Implantology, Room no. 003, Ground floor, Sharad Pawar Dental College, Sawangi

Wardha
MAHARASHTRA
442001
India 
Phone  08319131268  
Fax    
Email  shweta.bnbde@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Priyanka Jaiswal 
Designation  Professor 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of Periodontics and Implantology, Ground floor, Room no.003, Sharad Pawar Dental College, Sawangi

Wardha
MAHARASHTRA
442001
India 
Phone  9960713010  
Fax    
Email  priyankajacad@gmail.com  
 
Details of Contact Person
Public Query  
Name  Shweta Bhagat 
Designation  Post graduate student 
Affiliation  Datta Meghe Institute of Higher Education and Research 
Address  Department of Periodontics and Implantology, Ground floor, Room no. 003, Sharad Pawar Dental College,Sawangi

Wardha
MAHARASHTRA
442001
India 
Phone  08319131268  
Fax    
Email  shweta.bnbde@gmail.com  
 
Source of Monetary or Material Support  
Sharad Pawar Dental College, Sawangi(Meghe),Wardha,Maharashtra,India 
 
Primary Sponsor  
Name  Sharad Pawar Dental College 
Address  Datta Meghe Institute of Higher Education and Research 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
Nil   
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Shweta Bhagat  Sharad Pawar Dental College, Sawangi, Wardha  Department of Periodontics and Implantology, Ground floor, Room no. 003, Sharad PawarDental College, Sawangi
Wardha
MAHARASHTRA 		 08319131268

shweta.bnbde@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Infrabony defect 
Patients  (1) ICD-10 Condition: K056||Periodontal disease, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Deproteinized bovine bone matrix xenograft and A-PRF  A-PRF with deproteinized bovine bone matrix xenograft to be used in infrabony defect for periodontal regeneration 
Intervention  Deproteinized bovine bone matrix xenograft and collagen membrane  Bioresorbable collagen membrane with deproteinized bovine bone matrix xenograft to be used in infrabony defect for periodontal regeneration 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  45.00 Year(s)
Gender  Both 
Details  1) “Presence of at least 1 or 2 radiographically detectable interproximal infrabony osseous defect with probing pocket depth ≥ 5 mm and clinical attachment loss ≥ 5 mm following initial therapy.
2) Depth of intraosseous component of the defect ≥ 3 mm by clinical and radiographic means, which will be confirmed on intra-surgical measurement.
3) A radiographic base of the defect at least 3 mm coronal to the apex of the tooth.
4) Presence of at least 3 mm width of keratinized gingiva around test teeth to allow complete soft tissue coverage of the defect.”
 
 
ExclusionCriteria 
Details  1) “Evidence of localized aggressive periodontitis.
2) Patients with unacceptable oral hygiene (Plaque Index >1)
3) Smokers (recent history of smoking more than 10 cigarettes /day) or who used any of tobacco products.
4) Study tooth with inadequate endodontic / restorative treatments.
5) Study tooth with mobility exceeding grade II and exhibiting a class III or class IV furcation defect.
6) History of periodontal surgical therapy of the selected quadrant.
7) Pregnant females or lactating mothers.”
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Radiographic bone fill  At six months 
 
Secondary Outcome  
Outcome  TimePoints 
Plaque index,Papillary bleeding index,Periodontal pocket depth reduction,Clinical attachment level gain  At six months 
 
Target Sample Size   Total Sample Size="24"
Sample Size from India="24" 
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)   28/05/2024 
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)  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  

Introduction: Periodontitis is a chronic, multifactorial, inflammatory disease that leads to gradual loss of bone and periodontal attachment. Thus, periodontal surgery is required according to severity of diseases. The goal of periodontal reconstructive surgery is to regenerate soft and hard tissues destroyed during periodontal disease.

Aim: To compare the effectiveness of Bioresorbable Collagen Membrane in combination with Deproteinized Bovine Bone Matrix xenograft and Advanced Plasma rich fibrin(A-PRF) membrane in combination with Deproteinized Bovine Bone Matrix xenograft in the treatment of human infrabony defects.

Methods and Materials: This randomised controlled trial will be carried out at the periodontics outpatient department. We will choose 24 patients with moderate to advanced chronic periodontitis who are also systemically healthy. Infrabony defects will be treated by open flap debridement using bovine-derived xenograft and bioresorbable collagen membrane (group A) and open flap debridement using bovine-derived xenograft and A-PRF after the completion of first therapy (group B). At baseline and six months after undergoing periodontal surgery, probing pocket depth, clinical attachment level, radiographic bone fill, gingival recession, oral hygiene status, and gingival health were measured.

Expected Results: Bioresorbable Collagen Membrane and Advanced-Platelet Rich Fibrin Membrane in Combination with Deproteinized Bovine Bone Matrix Xenograft will lead to decrease in PPD, increase in CAL and better radiographic bone fill in infrabony defects.

Conclusion: It is suggested that Bioresorbable Collagen Membrane in combination with Deproteinized Bovine Bone Matrix xenograft will show better results as compared to Advanced Platelet Rich Fibrin Membrane with Deproteinized Bovine Bone Matrix Xenograft.

 
Close