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CTRI Number  CTRI/2026/01/100876 [Registered on: 12/01/2026] Trial Registered Prospectively
Last Modified On: 10/01/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A Clinical study comparing two treatment methods for bone healing in patients with Periodontal Bone Loss. 
Scientific Title of Study   Evaluation Of Recombinant Human Bone Morphogenic Protein (rhbmp-2) Plus Xenograft Versus Xenograft Alone As Compared To Open Flap Debridement In The Treatment of Intrabony Defects - A clinical And Rdiographic 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  Isha Gupta 
Designation  Post graduate student 
Affiliation  Dasmesh institute of research and dental sciences 
Address  Room no.5 department of periodontology and oral implantology, Dasmesh institute of research and dental sciences, Talwandi road

Faridkot
PUNJAB
151203
India 
Phone  9814650421  
Fax    
Email  ishag4178@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr. Preetika Bansal 
Designation  Professor 
Affiliation  Dasmesh institute of research and dental sciences 
Address  Room no.5 department of periodontology and oral implantology,Dasmesh institute of research and dental sciences, Talwandi road

Faridkot
PUNJAB
151203
India 
Phone  9814776744  
Fax    
Email  dr_preetika_11@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Isha Gupta 
Designation  Post graduate student 
Affiliation  Dasmesh institute of research and dental sciences 
Address  Room no.5 department of periodontology and oral implantology,Dasmesh institute of research and dental sciences, Talwandi road

Faridkot
PUNJAB
151203
India 
Phone  9814650421  
Fax    
Email  ishag4178@gmail.com  
 
Source of Monetary or Material Support  
Dasmesh institute of research and dental sciences, talwandi road, Faridkot-151203 
 
Primary Sponsor  
Name  Isha Gupta 
Address  Room no.5 department of periodontology and oral implantology,Dasmesh institute of research and dental sciences, Talwandi road 
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 
Isha Gupta  Dasmesh institute of research and dental sciences  Room no.5 department of periodontology and oral implantology,Dasmesh institute of research and dental sciences, Talwandi road
Faridkot
PUNJAB 		 9814650421

ishag4178@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL REVIEW BOARD Dasmesh institute of research and dental sciences faridkot  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: 2||Placement,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Open Flap Debridement  Patients will undergo open flap debridement where full thickness mucoperiosteal flaps will be elevated. Thorough debridement of intrabony defects and root planing will be performed. No graft or regenerative material will be placed. Flaps will be repositioned and sutured and standard postoperative care will be given and follow up will be done at 3 months and 6 months 
Intervention  rhbmp 2 plus xenograft  Patients will undergo open flap debridement with placement of xenograft combined with recombinant human bone morphogenetic protein 2 into the intrabony defect after debridement and root planing. The flap will be repositioned and sutured and standard postoperative care will be provided and follow up will be done at 3 months and 6 months 
Comparator Agent  Xenograft alone  Patients will undergo open flap debridement followed by placement of xenograft bone substitute into the intrabony defect after thorough debridement and root planing. The flap will be repositioned and sutured and standard postoperative care will be provided and follow up will be done at 3 months and 6 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  66.00 Year(s)
Gender  Both 
Details  systemically healthy patients having PPD of more than 5mm
presence of radiographic evidence of vertical bone loss 
 
ExclusionCriteria 
Details  patients with any uncontrolled systemic diseases such as diabetes mellitus and hypertension
smokers, alcohol abusers 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
to evaluate radiographic bone fill, rate of bone regeneration in all groups  assessed at baseline, 3months and 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
to evaluate pocket probing depth, relative attachment level  assessed at baseline,3months and 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   N/A 
Date of First Enrollment (India)   10/02/2026 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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 - 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

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

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

  6. For how long will this data be available start date provided 25-10-2025 and end date provided 08-01-2026?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This randomized clinical and radiographic study aims to evaluate and compare the effectiveness of recombinant human bone morphogenetic protein 2 combined with xenograft, xenograft alone, and open flap debridement in the treatment of periodontal intrabony defects. Patients with chronic periodontitis presenting with intrabony defects will be randomly allocated into three groups. Clinical parameters and radiographic defect fill will be assessed at baseline and follow up intervals to evaluate treatment outcomes. 
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