| CTRI Number |
CTRI/2026/01/100875 [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
|
This study compares two commonly used methods to preserve bone around dental implants placed immediately after tooth removal. One method uses a bone graft covered with a membrane prepared from the patient’s own blood, while the other uses a bone graft covered with a collagen membrane. |
|
Scientific Title of Study
|
Comparative evaluation of crestal bone height changes using bone graft with L-PRF membrane versus bone graft with collagen membrane in immediate dental implant placement in single rooted teeth: A clinico-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. Nitin Khuller |
| Designation |
HOD and Professor |
| Affiliation |
Dasmesh Institute of Research and Dental Sciences, Talwandi road |
| Address |
Room no. 5 Department of Periodontology and Oral Implantology, Dasmesh Institute of Research and Dental Sciences, Talwandi road
Faridkot
PUNJAB
151203
India |
| Phone |
8054443227 |
| Fax |
|
| Email |
nkhuller@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
PARUL SHARMA |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
DASMESH INSTITUTE OF RESEARCH AND DENTAL SCIENCES, FARIDKOT |
| Address |
DASMESH INSTITUTE OF RESEARCH AND DENTAL SCIENCES, FARIDKOT
PUNJAB
151203
India |
| Phone |
6283652196 |
| Fax |
|
| Email |
parul4524@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
PARUL SHARMA |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
DASMESH INSTITUTE OF RESEARCH AND DENTAL SCIENCES, FARIDKOT |
| Address |
DASMESH INSTITUTE OF RESEARCH AND DENTAL SCIENCES, FARIDKOT
PUNJAB
151203
India |
| Phone |
6283652196 |
| Fax |
|
| Email |
parul4524@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
PARUL SHARMA |
| 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
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| PARUL SHARMA |
Dasmesh Institute of Research and Dental Sciences, Talwandi road |
Room no. 5 Department of Periodontology and Oral Implantology, Dasmesh Institute of Research and Dental Sciences, Talwandi road
Faridkot
PUNJAB |
6283652196
parul4524@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 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 2||Placement, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
implant placement, filled with bone graft and covered collagen membrane. |
Clinical and radiographic evaluation of crestal bone height changes will be done at baseline, 3 and 6 months follow-up periods. |
| Intervention |
implant placement, filled with bone graft and covered with L-PRF membrane |
Clinical and radiographic evaluation of crestal bone height changes will be done at baseline, 3 and 6 months follow-up periods |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients having single or multiple single rooted teeth indicated for extraction followed by immediate implant placement.
Systemically healthy individuals |
|
| ExclusionCriteria |
| Details |
Patients with systemic conditions affecting bone healing (e.g., uncontrolled diabetes, osteoporosis)
Untreated periodontal disease
Patients on anticoagulant or immunosuppressive therapy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to evaluate crestal bone height changes and soft tissue changes in both the groups |
At baseline, at 3 and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Plaque index , Wasserman mobility index |
At baseline, at 3 & 6 months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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
- 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).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - NIL
- 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.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The present cinico-radiographic study aims to comparatively evaluate crestal bone height changes following immediate implant placement in single rooted teeth using bone graft with L-PRF membrane versus bone graft with collagen membrane. eligible participants will be randomly allocated into two parallel groups. |