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CTRI Number  CTRI/2025/06/089795 [Registered on: 30/06/2025] Trial Registered Prospectively
Last Modified On: 23/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Other 
Public Title of Study   Using powdered tooth in bone healing after extraction. 
Scientific Title of Study   A study on efficacy and outcome of autologous particulated tooth with platelet rich fibrin as bone graft in extraction socket preservation: A prospective clinical 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  Yerramaraju Vasanth Kumar Raju 
Designation  Post graduate 
Affiliation  Anil Neerukonda Institute of Dental Sciences 
Address  Department of Oral and Maxillofacial Surgery, Anil Neerukonda Institute of Dental Sciences, Visakhapatnam, Andhra Pradesh, India.

Visakhapatnam
ANDHRA PRADESH
531162
India 
Phone  9154420360  
Fax    
Email  vasanthkumarraju8@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Kuchimanchi Phani Kumar  
Designation  Professor and Head of the Department  
Affiliation  Anil Neerukonda Institute of Dental Sciences  
Address  Department of Oral and Maxillofacial Surgery, Anil Neerukonda Institute of Dental Sciences, Visakhapatnam, ANDHRA PRADESH, India.

Visakhapatnam
ANDHRA PRADESH
531162
India 
Phone  8096339404  
Fax    
Email  raghu8099@gmail.com    
 
Details of Contact Person
Public Query  
Name  Vasupalli Venkata Ramana Murthy 
Designation  Professor 
Affiliation  Anil Neerukonda Institute of Dental Sciences  
Address  Department of Oral and Maxillofacial Surgery, Anil Neerukonda Institute of Dental Sciences, Visakhapatnam, ANDHRA PRADESH, India.

Visakhapatnam
ANDHRA PRADESH
531162
India 
Phone  9849598601  
Fax    
Email  murthymaxfac@gmail.com  
 
Source of Monetary or Material Support  
Department of Oral and Maxillofacial Surgery, Anil Neerukonda Institute of Dental Sciences, Sangivalasa, Bheemunipatnam, Vishakapatnam, Andhra Pradesh, India. Pincode: 531162.  
 
Primary Sponsor  
Name  Yerramaraju Vasanth Kumar Raju 
Address  Department of Oral and Maxillofacial Surgery, Anil Neerukonda Institute of Dental Sciences, Sangivalasa, Bheemunipatnam, Vishakapatnam, Andhra Pradesh, India. Pincode: 531162. 
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 Yerramaraju Vasanth Kumar Raju  Anil Neerukonda Institute of Dental Sciences   Department of Oral and Maxillofacial Surgery, Anil Neerukonda Institute of Dental Sciences, Sangivalasa, Bheemunipatnam, Vishakapatnam, Andhra Pradesh, India. Pincode: 531162.
Visakhapatnam
ANDHRA PRADESH 		 9154420360

vasanthkumarraju8@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE-ANIDS  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  A study on efficacy and outcome of autologous particulated tooth with platelet rich fibrin as bone graft in extraction socket preservation: A prospective clinical study.  Autologous tooth as a bone graft material involves the use of a patient extracted tooth free from caries and infections along with PRF processed into a graft material for new bone formation. Total duration of study is 15 to 18 months starting from July 2025 and follow up for each case is 4 to 6 weeks. 
Comparator Agent  NIL  The study is a prospective clinical trial for objective radiographic assessment of autologous particulated tooth as bone graft in extraction socket preservation. so, this study doesnt have any comparator.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1. Age group from 18 to 50 years
2. Patients requiring extractions.
3. Extracted teeth free from caries, restorations and infections.
4. Tooth with poor prognosis without pulp involvement
5.Periodontally compromised tooth
6. Patients willing to participate in the study.  
 
ExclusionCriteria 
Details 
1. Edentulous patients.
2. Endodontically treated tooth.
3. Tooth associated with any benign or malignant pathological conditions like cysts and tumors.
4. Patients with systemic conditions affecting bone metabolism.
5. Patients under medication affecting bone metabolism.
6. Tooth with periapical abscess.
7. Tooth with grossly decayed or root stumps.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Enhance Bone Regeneration.
Accelerated Healing Process.
High Biocompatibility and Patient Safety.
Cost-Effectiveness.
Research-Specific Outcomes. 		 6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
New bone formation  6 weeks 
 
Target Sample Size   Total Sample Size="25"
Sample Size from India="25" 
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 2 
Date of First Enrollment (India)   12/07/2025 
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="1"
Months="6"
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 - 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 - Informed Consent Form

  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 (Others) -  on personal request

  6. For how long will this data be available start date provided 12-07-2027 and end date provided 12-07-2028?
    Response - Immediately following publication. No end date.

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

Autologous tooth as a bone graft material involves the use of a patient extracted tooth free from caries and infections along with PRF processed into a graft material for new bone formation

Dentin has an Osteoconductive Osteoinductive and Osteogenic properties promoting bone regeneration and healing

The structural compositional and histological similarities between dentin and bone both containing hydroxyapatite crystals type I collagen its biocompatibility regenerative potential and growth factors that promote Osteogenesis make it an effective bone graft material

It eliminates the risk of immune rejection and disease transmission associated with Allografts and Xenografts

The process involves crushing the tooth into fine particles to expose the collagen matrix and growth factors by adding Platelet Rich Fibrin enhancing the ability to support bone formation

This graft can be used in extracted socket preservation Implant dentistry alveolar ridge augmentation periodontology maxillofacial surgeries

 

 
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