| CTRI Number |
CTRI/2026/02/104535 [Registered on: 23/02/2026] Trial Registered Prospectively |
| Last Modified On: |
23/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to evaluate bone healing and stability of dental implants using a natural growth factor and special implant placement technique. |
|
Scientific Title of Study
|
Evaluation of crestal bone level changes and stability in implants treated with concentrated growth factor, placed using Osseo densification protocol. |
| Trial Acronym |
NIl |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhargava Kumar CH |
| Designation |
Post graduation,1st MDS |
| Affiliation |
Sibar institute of dental sciences |
| Address |
Room No : 3, Department Of Oral and Maxillofacial Surgery, PG Division, SIBAR Institute of Dental Sciences, Takkellapadu, Guntur.
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
8074294667 |
| Fax |
|
| Email |
bhargavjnv4@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR P Raja Satish |
| Designation |
Professor |
| Affiliation |
SIBAR Institute of Dental Sciences |
| Address |
Room No : 3, Department Of Oral and Maxillofacial Surgery, PG Division, SIBAR Institute of Dental Sciences, Takkellapadu, Guntur.
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9885319046 |
| Fax |
|
| Email |
rajasatish79@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR P Raja Satish |
| Designation |
Professor |
| Affiliation |
SIBAR Institute of Dental Sciences |
| Address |
Room No : 3, Department Of Oral and Maxillofacial Surgery, PG Division, SIBAR Institute of Dental Sciences, Takkellapadu, Guntur.
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9885319046 |
| Fax |
|
| Email |
rajasatish79@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Bhargava kumar ch |
| Address |
Room No: 3,SIBAR INSTITUTE OF DENTAL SCIENCES Takkellapadu, Guntur. Pincode 522509
|
| 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 |
| DR Bhargava Kumar CH |
SIBAR Institute Of Dental Sciences |
Room no:3,SIBAR INSTITUTE OF DENTAL SCIENCES Takkellapadu, Guntur. Pincode 522509
Guntur
ANDHRA PRADESH |
8074294667
bhargavjnv4@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Sibar Institute of Dental Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K084||Partial loss of teeth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
impalnt placement using osseo densification protocol with CGF
|
A crestal incision will be made at the planned implant site, and a full-thickness mucoperiosteal flap will be elevated to expose the alveolar bone. Osteotomy preparation will then be performed using the osseodensification protocol according to the recommended drilling sequence. The dental implant will be placed achieving adequate primary stability, followed by placement of the cover screw. A concentrated growth factor (CGF) membrane will be positioned over the implant site. The flap will be repositioned and secured with sutures to obtain primary closure. Post-operative instructions will be given as per standard protocol.
|
| Comparator Agent |
impalnt placement using osseo densification protocol without CGF |
A crestal incision will be made at the planned implant site, and a full-thickness mucoperiosteal flap will be elevated to expose the alveolar bone. Osteotomy preparation will then be performed using the osseodensification protocol according to the recommended drilling sequence. The dental implant will be placed achieving adequate primary stability, followed by placement of the cover screw. No CGF membrane will be used. The flap will be repositioned and secured with sutures to obtain primary closure. Post-operative instructions will be given as per standard protocol. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Male |
| Details |
Patients classified as ASA I, ASA II.
Patients aged 30-60 years.
Patients requiring implant placement in mandible
Patients willing to participate and provide written informed consent
D3 & D4 type of bone
|
|
| ExclusionCriteria |
| Details |
Patients on long-term medications affecting bone metabolism • Bisphosphonates • Long-term corticosteroids • Antiresorptive or antiangiogenic drugs
Patients suffering with diseases that affect the bone metabolisam include osteoporosis, osteomalacia, pagets disease, osteogenesis imperfecta etc.
Habitual smokers and tobacco chewers.
Patients with active local infection at the implant site
Pregnant women
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Clinical outcome - implant stability.
Radiological outcome – bone density and bone width
Crestal bone level changes
|
preop, immediate post op ,3 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="14"
Sample Size from India="14"
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)
|
20/03/2026 |
| 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 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 - NO
|
|
Brief Summary
|
This prospective randomized clinical study aims to evaluate the effect of concentrated growth factor (CGF) on implant stability and crestal bone level changes in dental implants placed using the osseodensification protocol. A total of 14 patients requiring mandibular implant placement will be randomly allocated into two groups: Group A (osseodensification with CGF) and Group B (osseodensification without CGF). Implant stability will be measured using resonance frequency analysis immediately after placement and at 3 months. Radiographic assessment will be used to evaluate crestal bone level, bone density, and bone width at preoperative, immediate postoperative, and 3-month intervals. CGF, being rich in growth factors, is expected to enhance bone healing and osseointegration
The study seeks to determine whether the adjunctive use of CGF with osseodensification provides superior implant stability and reduces crestal bone loss compared to the osseodensification technique alone, thereby improving overall implant success.
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