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CTRI Number  CTRI/2025/04/085890 [Registered on: 29/04/2025] Trial Registered Prospectively
Last Modified On: 29/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Comparing Treatments for Vertical Bone Defects: Autografts, Demineralised bone matrix, and Demineralised bone matrix with I-PRF. 
Scientific Title of Study   Comparative evaluation of the treatment outcomes for intrabony vertical defects by using intra oral osseous autograft, demineralized bone matrix alone and a combination of demineralized bone matrix and injectable platelet rich fibrin - a clinical and radiographic 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  Dr Pooja Singh 
Designation  Post graduate student 
Affiliation  SMBT Dental College and Hospital. 
Address  G-02 Department of Periodontology ,SMBT Dental College and Hospital Sangamner 422608

Ahmadnagar
MAHARASHTRA
422608
India 
Phone  9004843680  
Fax    
Email  poojavsingh1803@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Purushottam Rakhewar 
Designation  Head of Department and PG Guide 
Affiliation  SMBT Dental College and Hospital 
Address  G- 02 Department of Periodontology, SMBT Dental College and Hospital Sangamner 422608

Ahmadnagar
MAHARASHTRA
422608
India 
Phone  9370017343  
Fax    
Email  drpsrakhewar@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Pooja Singh 
Designation  Post graduate student 
Affiliation  SMBT Dental College and Hospital 
Address  G-02 Department of Periodontology ,SMBT DENTAL COLLEGE AND HOSPITAL , GHULEWADI SANGAMNER 422608

Ahmadnagar
MAHARASHTRA
422608
India 
Phone  9004843680  
Fax    
Email  poojavsingh1803@gmail.com  
 
Source of Monetary or Material Support  
SMBT Dental College and Hospital Sangamner, Ahmednagar, Maharastra, India, 422608  
 
Primary Sponsor  
Name  Dr Pooja Singh 
Address  G-02, Department of Periodontology, SMBT Dental College and Hospital, Ghulewadi, Sangamner, Ahmednagar, Maharashtra, India, 422608 
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 
Dr Pooja Singh  SMBT Dental college and hospital   G- 02 Department of Periodontology, Ghulewadi-Amrutnagar, Sangamner 422608
Ahmadnagar
MAHARASHTRA 		 9004843680

poojavsingh1803@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Committee on Ethics, SMBT Dental college, sangamner  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K053||Chronic periodontitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Autogenous bone graft  The Bone scraper will be used for bone removal and autogenous bone grafting. The graft procured will be directly placed into the recipient site. Autogenous bone graft will be used to cover the osseous defect in the control group. The follow up will be done after 3 months and 6 months.  
Intervention  Combination of Demineralised bone matrix + Injectable platelet rich fibrin.   In the experimental group, a combination of demineralized bone matrix (DBM) and injectable platelet-rich fibrin (i-PRF) will be used to fill the intrabony osseous defect. DBM will serve as the primary scaffold for bone regeneration, while i-PRF, rich in growth factors, will enhance healing by promoting cell migration, angiogenesis, and tissue regeneration. The two materials will be thoroughly mixed before application to ensure optimal integration within the defect site. Clinical and radiographic follow-ups will be conducted at 3 months and 6 months post-operatively to assess the extent of bone fill, changes in probing depth, clinical attachment gain, and overall periodontal healing. These time intervals are selected to evaluate both the early and mid-term regenerative outcomes of the combination therapy. 
Intervention  Osseous bone graft  In the test group, the intrabony vertical defect will be treated using demineralized bone matrix (DBM) as the grafting material. DBM will be carefully placed into the osseous defect following standard debridement and defect preparation procedures to promote bone regeneration. The primary aim is to evaluate the regenerative potential of DBM in periodontal bone defects. Post-operative clinical and radiographic assessments will be conducted at two intervals — 3 months and 6 months — to monitor healing, assess defect fill, and evaluate improvements in clinical parameters such as probing depth and clinical attachment level. These time points are chosen to observe both early and intermediate healing responses to the graft material. 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1.Presence of periodontitis with vertical intrabony defect having probing pocket depth PPD greater than or equal to 5 mm, radiographic defect depth greater than or equal to 3mm after phase I therapy (scaling and root planning).
2. Absence of any anatomical limitations
3. Patient willing to undergo surgery and ready to give written consent.
 
 
ExclusionCriteria 
Details  1 Patients with systemic diseases, smokers and pregnant women.
2.Individuals with unacceptable oral hygiene.
3.Patients contraindicated for periodontal surgery.
4.Patients undergone periodontal therapy for past 6 months.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Other 
Blinding/Masking   Investigator Blinded 
Primary Outcome  
Outcome  TimePoints 
i.Plaque index
ii. Gingival index
iii.Probing pocket depth (PPD) in mm.
iv. Relative clinical attachment level (RCAL) in mm is measured from the fixed marked point at apical level of customized acrylic stents to the base of pocket with grooves to ensure a reproducible placement of a periodontal (UNC 15) probe.
v. Bleeding on probing (Ainamo and Bay 1976)
vi.Radiographic measurements. Radiographic measurements will be carried out on intra oral periapical radiographs by paralleling technique with grid (having 1 mm compartments)
 		 Baseline three months six months 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="45"
Sample Size from India="45" 
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 4 
Date of First Enrollment (India)   15/05/2025 
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="0"
Months="9"
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 - 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 - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

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

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [poojavsingh1803@gmail.com].

  6. For how long will this data be available start date provided 15-05-2025 and end date provided 15-11-2026?
    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 study aims to compare the treatment outcomes for intrabony vertical defects using three different regenerative techniques: intraoral osseous autograft, demineralized bone matrix (DBM) alone, and a combination of DBM and injectable platelet-rich fibrin (i-PRF). It seeks to evaluate both clinical and radiographic outcomes, including probing depth, clinical attachment level, gingival recession, bone fill, and defect morphology. A randomized controlled trial design will be employed, with patients having vertical intrabony defects undergoing standardized surgical procedures. Follow-up evaluations will occur at 3, 6, and 12 months post-treatment to assess the effectiveness of each technique.

The clinical evaluation will focus on parameters such as probing depth, clinical attachment level, and postoperative pain, while radiographic evaluation will assess the degree of bone regeneration and changes in defect morphology. The study hypothesizes that intraoral osseous autograft, being a gold standard, will show superior results in bone regeneration. DBM alone is expected to provide moderate regeneration, while the combination of DBM and i-PRF may offer enhanced healing due to the growth factors in the platelet-rich fibrin. The findings will provide valuable insights into the effectiveness of these treatment options and help optimize regenerative protocols for managing periodontal defects.

 
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