| CTRI Number |
CTRI/2025/05/087893 [Registered on: 29/05/2025] Trial Registered Prospectively |
| Last Modified On: |
09/04/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Study to assess bone height changes around dental implants by using Concentrated Growth Factor at the implant placement site
|
|
Scientific Title of Study
|
Clinical and Radiographic Evaluation of Concentrated Growth Factor on Osseointegration around Endosseous Implants . |
| Trial Acronym |
nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Allu Priyanka |
| Designation |
MDS |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
Room no.8,2nd floor, Departnment of Periodontics, Sibar Institute of Dental Sciences, Takkellapadu,522509
Guntur
Andhra Pradesh,522509
India
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
6303901830 |
| Fax |
|
| Email |
parimalaallu08@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Anumala Deepa |
| Designation |
Professor |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
Room no.8,2nd floor, Departnment of Periodontics, Sibar Institute of Dental Sciences, Takkellapadu,522509
Guntur
Andhra Pradesh, 522509
India
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
9618501146 |
| Fax |
|
| Email |
anumala.deepas@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Allu Priyanka |
| Designation |
MDS |
| Affiliation |
Sibar Institute of Dental Sciences |
| Address |
Room no.8,2nd floor, Departnment of Periodontics, Sibar Institute of Dental Sciences, Takkellapadu,522509
Guntur
Andhra Pradesh, 522509
India
Guntur
ANDHRA PRADESH
522509
India |
| Phone |
6303901830 |
| Fax |
|
| Email |
parimalaallu08@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no-8,2nd floor, Departnment of Periodontics, Sibar Institute of Dental Sciences, Takkellapadu,522509,India. |
|
|
Primary Sponsor
|
| Name |
Allu Priyanka |
| Address |
Room no.8,2nd floor, Departnment of Periodontics, Sibar Institute of Dental Sciences,Takkellapadu,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 Allu Priyanka |
Sibar Institute of Dental Sciences |
Room no-8,2nd floor, Departnment of Periodontics, Takkellapadu,522509 Guntur
Andhra Pradesh
Guntur
ANDHRA PRADESH |
6303901830
parimalaallu08@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| sibar institute of dental sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Implants with Concentrated growth factor |
Implant will be placed with Concentrated growth factor at osteotomy site, and patients will be followed up at 3 months and 6 months for evaluating parameters. |
| Comparator Agent |
Implants without Concentrated Growth Factor |
Implant will be placed without Concentrated growth factor at osteotomy site, and patients will be followed up at 3 months and 6 months for evaluating parameters |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with an age group of 20-60 years of either gender.
Patients in need of implant supported tooth replacement.
Presence of adequate keratinized mucosa (minimum 1 mm) in the edentulous site.
Apparently healthy patients.
Patients with bone density classified as D2 and D3 type of bone using CBCT.
|
|
| ExclusionCriteria |
| Details |
1. Any forms of tobacco users.
2. Pregnant and lactating women.
3. Patients taking any medication which effect healing and bone metabolism.
4. Patients with a history of immune disease, uncontrolled diabetes, blood disorders, ongoing chemotherapy, radiation treatment to head and neck, alcohol or drug abuse, psychological instability.
5. Patients with parafunctional habits.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Centralized |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the implant stability around implants with Concentrated growth factor. |
Baseline and 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the crestal bone level around implants with Concentrated growth factor. |
Baseline and 3 months and 6 months |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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)
|
10/06/2025 |
| 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="1"
Months="6"
Days="1" |
|
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 is a randomized control trail .Patient selection will be done after the assessment of eligibility criteria. In Phase I therapy oral prophylaxis and surgical stunt fabrication will be done. And patient will be recalled after 1 week for surgical procedure.The procedure will be performed under local anesthesia using 2% lignocaine containing adrenaline 1:80,000.A midcrestal incision will be given in both cases. A mucoperiosteal flap will be elevated and osteotomy site will be prepared.In Group 1 patients, implants will be placed without CGF and in Group 2 implants will be placed with CGF. After placement, stability will be checked with RFA at baseline.Cover screw will be given following the implant placement and flaps will be approximated and sutured. Patient will be recalled after 3 months and 6 months for evaluation of parameters like RFA and IOPA. |