| CTRI Number |
CTRI/2025/05/087474 [Registered on: 23/05/2025] Trial Registered Prospectively |
| Last Modified On: |
22/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Crestal Bone Loss Around Dental Implants with and without recombinant human bone morphogenetic protein Coating: A CBCT Study |
|
Scientific Title of Study
|
Comparative evaluation of crestal bone loss around dental implant with and without coating of Recombinant Human Bone Morphogenic Protein-2 (rhBMP-2): A Clinico Radiographic CBCT 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. Anuradha Mehra |
| Designation |
Junior Resident |
| Affiliation |
Subharti Dental College And Hospital |
| Address |
Subharti Dental College
Swami Vivekanand Subharti University
Subharti Puram
NH-58, Delhi Haridwar By-Pass Road, Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
8383062129 |
| Fax |
|
| Email |
anuradhamehra453@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Soundarya Singh |
| Designation |
Associate Professor |
| Affiliation |
Surbharti Dental College And Hospital |
| Address |
Subharti Dental College
Swami Vivekanand Subharti University
Subharti Puram
NH-58, Delhi Haridwar By Pass Road, Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
8383062129 |
| Fax |
|
| Email |
singhsoundarya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Anuradha Mehra |
| Designation |
Junior Resident |
| Affiliation |
Subharti Dental College And Hospital |
| Address |
Subharti Dental College
Swami Vivekanand Subharti University
Subharti Puram
NH-58, Delhi Haridwar BY Pass Road, Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
8383062129 |
| Fax |
|
| Email |
anuradhamehra453@gmail.com |
|
|
Source of Monetary or Material Support
|
| Subharti Dental College And Hospital
Swami Vivekanand Subharti University
Subharti Puram
NH-58, Delhi Haridwar BY Pass Road, Meerut, Uttar Pradesh- 250005, India |
|
|
Primary Sponsor
|
| Name |
Dr Anuradha Mehra |
| Address |
Subharti Dental College
Swami Vivekanand Subharti University
Subharti Puram
NH-58, Delhi Haridwar By-Pass Road, Meerut, Uttar Pradesh- 250005, India
|
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Soundarya Singh |
Subharti Dental College And Hospital
Swami Vivekanand Subharti University
Subharti Puram
NH-58, Delhi Haridwar By Pass Road, Meerut
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Anuradha Mehra |
Subharti Dental College And Hospital |
Room No 2 Department Of Periodontology and Implantology NH 58 Delhi Haridwar By Pass Road
Meerut
UTTAR PRADESH |
8383062129
anuradhamehra453@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee Medical |
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 |
Implant only |
The Implant will not be coated with rhBMP-2 |
| Intervention |
Implant with rhBMP2 |
The Implant will be coated with rhBMP-2 at the time of placement. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients having single missing tooth with an adequate width and height of edentulous space available for placement of implant.
2. Edentulous sites in mandibular and maxillary arches.
3. Adjacent teeth intact; restored with functionally & esthetically good restorations; restored with prosthesis precluding the addition of the missing tooth.
4. Patients with good periodontal and general health. |
|
| ExclusionCriteria |
| Details |
1. Patients who are unable to perform routine oral hygiene procedures.
2. Patients with history of smoking.
3. Patients with TMJ disorders.
4. Patients with dental history of bruxism and parafunctional habits or deep bite cases.
5. History of substance abuse.
6. Insufficient vertical inter arch space to accommodate the prosthodontic components available, together with a proposed pontic and occasional gingival analogue designs.
7. Patients with uncontrolled diabetes.
8. Absence of opposing occlusion. |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Crestal Bone Loss Around Dental Implants |
At Baseline 4 Months 9 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Soft Tissue Changes Around The Dental Implant |
At Baseline 4 Months 9 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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
02/06/2025 |
| 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="2"
Months="2"
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
|
In this study we will be randomly selecting 20 patients according to the inclusion and exclusion criteria. 10 patients will be in the test group, where implants will be coated with rhBMP-2 prior to their placement into the osteotomy site. The other 10 patients will be the control group, where the implants will be without the coating of rhBMP-2. At baseline RVG and CBCT will be recorded. The patients will then be re-called after 4 months, and again after 9 months, when the RVG and CBCT will be repeated and the data will be collected. The data of both groups will be statistical analysed for obtaining the final results and drawing conclusions. |