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CTRI Number  CTRI/2025/11/097258 [Registered on: 11/11/2025] Trial Registered Prospectively
Last Modified On: 11/11/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Dentistry 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A study among patients undergoing tooth extraction to compare bone healing using bone graft alone and Bone graft enriched with Vitamin D3. 
Scientific Title of Study   Comparative evaluation of efficacy of DFDBA and DFDBA enriched with Vitamin D3 in alveolar socket preservation A Clinical Radiographic and Histologic 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 Prachi Rathi 
Designation  Assistant Professor 
Affiliation  Ranjeet Deshmukh Dental College and Research Centre Nagpur 
Address  104 Department of Periodontics and Implantology Ranjeet Deshmukh Dental College and Research Centre Nagpur

Nagpur
MAHARASHTRA
440019
India 
Phone  9975216388  
Fax    
Email  prachi.rathi.9@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Prachi Rathi 
Designation  Assistant Professor 
Affiliation  Ranjeet Deshmukh Dental College and Research Centre Nagpur 
Address  104 Department of Periodontics and Implantology Ranjeet Deshmukh Dental College and Research Centre Nagpur


MAHARASHTRA
440019
India 
Phone  9975216388  
Fax    
Email  prachi.rathi.9@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Prachi Rathi 
Designation  Assistant Professor 
Affiliation  Ranjeet Deshmukh Dental College and Research Centre Nagpur 
Address  104 Department of Periodontics and Implantology Ranjeet Deshmukh Dental College and Research Centre Nagpur


MAHARASHTRA
440019
India 
Phone  9975216388  
Fax    
Email  prachi.rathi.9@gmail.com  
 
Source of Monetary or Material Support  
Ranjeet Deshmukh Dental College and Research Centre, Nagpur 
 
Primary Sponsor  
Name  NIL 
Address  NIL 
Type of Sponsor  Other [NIL] 
 
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 Abhay Kolte  Ranjeet Deshmukh Dental College and Research Centre  104 Department of Periodontics and Implantology
Nagpur
MAHARASHTRA 
9011071467

drabhaypkolte@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE RANJEET DESHMUKH DENTAL COLLEGE AND RESEARCH CENTRE NAGPUR  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K068||Other specified disorders of gingiva and edentulous alveolar ridge,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  DFDBA  A full thickness mucoperiosteal flap with two vertical incisions will be reflected and tooth extraction will be carried out. After debridement of socket, DFDBA will be placed in one group. The flap will be coronally advanced and post-extraction socket will be sealed with suturing  
Intervention  DFDBA with Vitamin D3 gel  A full thickness mucoperiosteal flap with two vertical incisions will be reflected and tooth extraction will be carried out. After debridement of socket, DFDBA and Vitamin D3 will be placed in intervention group. The flap will be coronally advanced and post-extraction socket will be sealed with suturing. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  58.00 Year(s)
Gender  Both 
Details  Patients above the age of 18 years,
Patients with no medical history that contraindicates the surgical procedure,
adequate space for a satisfactory implant restoration.
Only maxillary and mandibular premolars or molars indicated for extraction, and replacement with dental implant.
 
 
ExclusionCriteria 
Details  Patients with a history of any systemic diseases that might impair bone metabolism,
Patients that exhibited poor oral hygiene,
Patients demonstrating a buccal dehiscence of more than 25% of the length of the tooth,
Edentulous spaces adjacent to the tooth indicated for extraction,
Patients who are smokers,
Patients on antiresorptive therapy (as bisphosphonates), and
Pregnancy and nursing period, psychiatric conditions, and oncologically relevant diseases.
 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
bone formation in Alveolar socket  Baseline and 6 Months 
 
Secondary Outcome  
Outcome  TimePoints 
Soft tissue healing
Buccolingual width of alveolar ridge
Vertical ridge resorption
Percentage of vital bone formation 
Baseline and 6 months 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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 3 
Date of First Enrollment (India)   02/01/2026 
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="1"
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 - NO
Brief Summary  

Tooth extraction is frequently followed by significant bone loss, resulting in reduced alveolar ridge height and width that can compromise subsequent implant placement and aesthetics. Alveolar ridge preservation techniques aim to minimize this bone resorption using bone grafts and adjunctive agents. Demineralized Freeze-Dried Bone Allograft also known as DFDBA is a well documented allograft material for socket preservation due to its osteoinductive potential.

Vitamin D3 plays a crucial role in calcium metabolism and bone remodeling by promoting osteoblastic activity and mineralization. Its topical incorporation into bone grafts may enhance graft integration and new bone formation.

This randomized controlled clinical trial aims to compare the efficacy of DFDBA alone and DFDBA enriched with Vitamin D3 gel in post-extraction alveolar socket preservation. Sixty patients requiring extraction of a single tooth preferably premolar or molar and subsequent implant placement will be recruited and randomly assigned into two groups:

Group I: Socket preservation using DFDBA alone

Group II: Socket preservation using DFDBA enriched with Vitamin D3 gel

Clinical evaluation for assessing soft tissue healing, radiographic assessment for ridge height and width using RVG and CBCT, and histologic analysis for vital bone formation, residual graft, connective tissue content will be performed at baseline and after 6 months.

The study is expected to determine whether Vitamin D3 supplementation enhances the regenerative potential of DFDBA, resulting in improved bone quality and quantity for future implant placement.

Study Design: Double-blinded, randomized controlled clinical trial
Study Duration: 18 months
Sample Size: 60 participants
Study Site: Ranjeet Deshmukh Dental College and Research Centre, Nagpur

 
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