| 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
|
|
|
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
|
|
|
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 |