| CTRI Number |
CTRI/2025/06/089717 [Registered on: 27/06/2025] Trial Registered Prospectively |
| Last Modified On: |
26/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparing Bone Healing With and Without a Growth Protein in Gum Disease Treatment |
|
Scientific Title of Study
|
Evaluating the effect of TGF beta 1 with bone graft and bone graft alone in the treatment of intrabony defect 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 Shagun Desai |
| Designation |
post graduate student |
| Affiliation |
Manubhai Patel Dental College and Hospital & ORI |
| Address |
Manubhai Patel Dental College and Hospital and ORI Vishwajyoti ashram near Vishwamitri bridge munjmahuda Vadodara Gujarat
ground floor department of periodontics and implantology Manubhai Patel Dental College and Hospital and ORI Vishwajyoti ashram near Vishwamitri bridge munjmahuda Vadodara Gujarat
Vadodara
GUJARAT
390011
India |
| Phone |
07265902204 |
| Fax |
|
| Email |
desaishagun147@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Priyadarshini Nadig |
| Designation |
Professor |
| Affiliation |
Manubhai Patel Dental College and Hospital and ORI |
| Address |
ground floor department of periodontics and implantology Manubhai Patel Dental College and Hospital and ORI Vishwajyoti ashram near Vishwamitri bridge munjmahuda Vadodara Gujarat
ground floor department of periodontics and implantology manubhai patel dental college and hospital and ORI
Vadodara
GUJARAT
390011
India |
| Phone |
7567796090 |
| Fax |
|
| Email |
priya_darshinikud@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Priyadarshini Nadig |
| Designation |
Professor |
| Affiliation |
Manubhai Patel Dental College and Hospital and ORI |
| Address |
ground floor department of periodontics and implantology Manubhai Patel Dental College and Hospital and ORI Vishwajyoti ashram near Vishwamitri bridge munjmahuda Vadodara Gujarat
ground floor department of periodontics and implantology manubhai patel dental college and hospital and ORI
Vadodara
GUJARAT
390011
India |
| Phone |
7567796090 |
| Fax |
|
| Email |
priya_darshinikud@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Shagun Desai
department of periodontics and implantology Manubhai Pqatel Dental College and Hospital and ORI mujmahuda Vadodara gujarat 390011 |
|
|
Primary Sponsor
|
| Name |
Dr Shagun Desai |
| Address |
Manubhai Patel Dental College and Hospital and ORI |
| 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 Shagun Desai |
Manubhai Patel Dental College and Hospital and ORI |
department of periodontics and implantology Manubhai Patel Dental College and Hospital and ORI Vadodara, 390011
Vadodara
GUJARAT |
07265902204
desaishagun147@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICAL COMMITTEE (IEC) FOR RESEARCH, Manubhai Patel Dental College and Hospital and ORI |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: 8||Other Procedures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bone graft |
To assess the clinical and radiographic outcomes of bone graft alone in the treatment of intrabony defect at baseline and 6 months |
| Intervention |
bone graft with tgf beta 1 |
To assess the clinical and radiographic outcomes of bone graft plus TGF beta 1 in the treatment of intrabony defect at baseline and 6 months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1. The sites should exhibit radiographic evidence of intrabony defects more than 3mm deep.
2. The site should exhibit 2 or 3 walled defects.
3. Interproximal probing depth more than 5mm following phase I therapy
4. Age between 20 to 55years.
5. Systemically healthy patient. |
|
| ExclusionCriteria |
| Details |
1. Subjects who have received periodontal flap / regenerative therapy within the past 1 year.
2. Pregnant and lactating patients
3. Current smokers and tobacco users.
4. Patients who demonstrate poor oral hygiene maintenance and non-compliance.
5. Teeth with Grade III mobility.
6. Patients with uncontrolled systemic condition who are contraindicated for surgery.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
•To assess the clinical and radiographic outcomes of bone graft plus TGF-beta1 in the treatment of intrabony defect.
• To assess the clinical and radiographic outcomes of bone graft alone in the treatment of intrabony defect.
•To compare the clinical and radiographic outcomes in both the groups.
|
6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•To compare the clinical and radiographic outcomes in both the groups.
|
6 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2/ Phase 3 |
|
Date of First Enrollment (India)
|
22/07/2025 |
| 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="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
|
|
The aim of the study is to compare the clinical and radiographic
outcomes of bone graft with and without TGF beta1 growth factor in the treatment
of intrabony defect.
To assess the clinical and
radiographic outcomes of bone graft plus TGF beta1 in the treatment of intrabony
defect.
To assess the clinical and
radiographic outcomes of bone graft alone in the treatment of intrabony
defect.
To compare the clinical and
radiographic outcomes in both the groups.
|
|