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CTRI Number  CTRI/2026/01/102412 [Registered on: 29/01/2026] Trial Registered Prospectively
Last Modified On: 19/05/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A RANDOMIZED CONTROLLED CLINICAL TRIAL TO COMPARE THE EFFICACY OF AN ALLOPLAST WITH OR WITHOUT “ADVANCED-PRF+” USING MINIMALLY INVASIVE SURGICAL TECHNIQUE IN THE MANAGEMENT OF PERIODONTAL INFRABONY DEFECTS 
Scientific Title of Study   A RANDOMIZED CONTROLLED CLINICAL TRIAL TO COMPARE THE EFFICACY OF AN ALLOPLAST WITH OR WITHOUT “ADVANCED-PRF+” USING MINIMALLY INVASIVE SURGICAL TECHNIQUE IN THE MANAGEMENT OF PERIODONTAL INFRABONY DEFECTS 
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 Priyanshi 
Designation  Post graduate student 
Affiliation  J.N Kapoor D.A.V Centenary Dental College 
Address  1060 Sector 17 Huda Near Jindal Hospital Jagadhri
J.N Kapoor D.A.V Centenary Dental College Model town Yamunanagar Haryana 135001
Yamunanagar
HARYANA
135003
India 
Phone  8059589447  
Fax    
Email  priyanshibajaj08@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Priyanshi 
Designation  Post graduate student 
Affiliation  J.N Kapoor D.A.V Centenary Dental College 
Address  J.N Kapoor D.A.V Centenary Dental College Department no.-8 Model Town Yamunanagar Haryana
J.N Kapoor D.A.V Centenary Dental College Department no.-8 Model Town Yamunanagar Haryana
Yamunanagar
HARYANA
135001
India 
Phone  8059589447  
Fax    
Email  priyanshibajaj08@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Priyanshi 
Designation  Post graduate student 
Affiliation  J.N Kapoor D.A.V Centenary Dental College 
Address  1060 Sector 17 Huda Near Jindal Hospital Jagadhri
J.N Kapoor D.A.V Centenary Dental College Model town Yamunanagar Haryana 135001
Yamunanagar
HARYANA
135003
India 
Phone  8059589447  
Fax    
Email  priyanshibajaj08@gmail.com  
 
Source of Monetary or Material Support  
J.N. Kapoor D.A.V Centenary Dental College Model Town Yamunanagar Haryana 135001 
 
Primary Sponsor  
Name  J.N. Kapoor D.A.V Centenary Dental College 
Address  J.N. Kapoor D.A.V Centenary Dental College Model Town Yamunanagar Haryana 135001 
Type of Sponsor  Other [Private Dental 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 Priyanshi  Department of Periodontology and Oral Implantology  J.N Kapoor D.A.V Centenary Dental College Department no.-8 Model Town Yamunanagar Haryana
Yamunanagar
HARYANA 		 8059589447

priyanshibajaj08@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Periodontitis patients with infrabony defects 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Alloplast   Nanocrystalline hydroxyapatite graft  
Comparator Agent  Alloplast + A-PRF+  Nanocrystalline hydroxyapatite graft + A-PRF+ with patients blood 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients with age more than or equal to 18 with periodontitis.
2. Patients with at least one or more sites with periodontal probing depth (PD) more than or equal to 5 mm when measured using a manual periodontal probe (UNC 15) and CAL more than or equal to 5 mm.
3. Radiographic presence of at least one infrabony osseous defect having depth more than or equal to 3 mm as measured.
4. Patients who will have full-mouth plaque score(FMPS) and full-mouth bleeding score(FMBS) less than or equal to 20 percent
5. Patients who will give consent for participation in the study and shall also be available for all follow periods.
 
 
ExclusionCriteria 
Details  1. Patients with any known systemic disease and drug or medication or therapeutic regimen that might interfere with wound healing of soft tissue or bone.
2. Patients who have habit of smoking and or consuming alcohol.
3. Patients allergic to any drug and or material, used in the study.
4. Patients unable or unwilling to undergo surgical procedure.
5. Patients who are pregnant or lactating females.
6. Patients who had undergone periodontal treatment in the previous 6 months.
7. Patients with parafunctional habits such as bruxism.
8. Defect sites with teeth having more than or equal to Grade II furcation involvement.
9. Defect Sites with teeth having mobility more than or equal to Grade III.
10. Defect sites around third molar.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
A. Clinical Parameters
i. Clinical attachment level (CAL)
ii. Pocket depth (PD)
B. Radiographic parameters
i. Defect depth
ii. Amount of defect fill
iii. Percentage of defect fill
iv. Amount of defect resolution
v. Percentage of defect resolution
 		 baseline
12 weeks
24 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Clinical Parameters-
i. Plaque index (PI)
ii. Gingival bleeding index (GBI)
 		 Baseline
12 weeks
24 weeks 
 
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)   20/02/2026 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  20/02/2026 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Open to Recruitment 
Recruitment Status of Trial (India)  Open to Recruitment 
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 - 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 -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    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 20-06-2025 and end date provided 20-06-2026?
    Response - Immediately following publication. No end date.

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

RESEARCH QUESTION

 

Whether alloplast alone or in combination along with “A-PRF+” using Minimally Invasive Surgical Technique (MIST) is more effective in treatment of periodontal infrabony defects.

AIM AND OBJECTIVES

 

AIM :- To evaluate the efficacy of alloplast alone or in combination with “A-PRF+” in the treatment of periodontal infrabony defects using minimally invasive surgical technique (MIST).

 

OBJECTIVES :- 

1)    To evaluate clinically and radiologically the efficacy of alloplast alone in treatment of periodontal infrabony defects using minimally invasive surgical technique.

2)    To evaluate clinically and  radiologically  the efficacy of alloplast along with “A-PRF+” in treatment of periodontal infrabony defects using minimally invasive surgical technique.

3)    To compare clinically and radiologically the efficacy of use of alloplast vs alloplast along with “A-PRF+” in the treatment of periodontal infrabony defects using minimally invasive surgical technique.

 
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