| CTRI Number |
CTRI/2024/11/077464 [Registered on: 28/11/2024] Trial Registered Prospectively |
| Last Modified On: |
05/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Bone graft with or without growth factor in bone defects |
|
Scientific Title of Study
|
Comparative Evaluation of Efficacy of Demineralized Freeze Dried Bone Allograft (DFDBA)With or Without Recombinant Human Bone Morphogenetic Protein (Rh-BMP2) in the Treatment of Human Intrabony Periodontal Defects. 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 |
Ginni Verma |
| Designation |
Junior Resident |
| Affiliation |
Subharti Dental College and Hospital |
| Address |
Department of Periodontology
Subharti Dental College and Hospital
Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
8448214954 |
| Fax |
|
| Email |
ginniverma662@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivi Khattri |
| Designation |
Associate Professor |
| Affiliation |
Subharti Dental College and Hospital |
| Address |
Department of Periodontology
Subharti Dental College and Hospital
Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9627600088 |
| Fax |
|
| Email |
shivikhattri123@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ginni Verma |
| Designation |
Junior Resident |
| Affiliation |
Subharti Dental College and Hospital |
| Address |
Department of Periodontology
Subharti Dental College and Hospital
Meerut
UTTAR PRADESH
250005
India |
| Phone |
8448214954 |
| Fax |
|
| Email |
ginniverma662@gmail.com |
|
|
Source of Monetary or Material Support
|
| Subharti Dental College & Hospital
Swami Vivekanand Subharti University
Meerut 250005
Uttar Pradesh
India |
|
|
Primary Sponsor
|
| Name |
Ginni Verma |
| Address |
Department of Periodontology
Subharti Dental College and Hospital
NH 58 Delhi Haridwar Bypass Road Meerut 250005
Meerut
Uttar Pradesh
India |
| 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 Ginni Verma |
Subharti Dental College and Hospital |
Room No 2
Department of Periodontology and Implantology
Ground floor
Subharti dental college and hospital
Swami Vivekanand Subharti University, NH-58, Delhi Haridwar Bypass Road, Meerut
Meerut
UTTAR PRADESH |
8448214954
ginniverma662@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee,Swami Vivekanand Subharti University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, (2) ICD-10 Condition: K03||Other diseases of hard tissues ofteeth, (3) ICD-10 Condition: Z789||Other specified health status, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Bone graft only |
Open flap debridement with DFDBA.
Frequency-Patient recall after 1 week,3 months and 6 months
Total duration-6 months for follow up |
| Intervention |
rhBMP2 group |
Open flap debridement with rhBMP-2 with or without DFDBA.
Frequency-Patient recall after 1 week, 3 months and 6 months
Total duration- 6 months for follow up |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1) Age group ranging from 20-55 years.
2) Patients having minimum 20 teeth.
3) Clinical attachment loss ≥ 3mm
4) Subjects of either sex having Generalised Chronic Periodontitis
5) Subjects who are systemically healthy with no contraindication to Periodontal surgery.
6) Presence of PD ≥ 5mm with radiographic evidence of angular bone loss.
7) Compliant subjects.
|
|
| ExclusionCriteria |
| Details |
1) Subjects having any deleterious habits, such as smoking or tobacco chewing.
2) Subjects with history of any systemic disease.
3) Subjects who are sensitive to or shows any allergic reaction to any medication or any ingredient of the test- material.
4) Periodontal defect sites with one walled intra-bony defect.
5) Subjects showing unacceptable oral hygiene compliance during / after Phase-I therapy.
6) Pregnant or lactating females.
7) Subjects having undergone any periodontal therapy in the past three months.
8) Subjects prescribed with steroids/chemotherapy/radiotherapy.
9) Patient with any bleeding disorders.
10) Patient taking any medication which may affect wound healing.
11) Non-compliant subjects.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Clinical attachment level/ Relative attachment level, Radiographic bone fill |
3 Months and 6 Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Probing pocket depth |
3 Months and 6 Months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
Final Enrollment numbers achieved (Total)= "20"
Final Enrollment numbers achieved (India)="20" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
10/12/2024 |
| Date of Study Completion (India) |
13/05/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Completed |
Publication Details
Modification(s)
|
IN PROCESS OF PUBLICATION |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
Patients with intrabony defects confirmed with a radiograph, will be subjected to open flap debridement + DFDBA with or without rhBMP-2. Patient will be inducted for study and after obtaining written consent. Phase 1 therapy will be carried out. This will be followed by the surgical procedure in the patients as mentioned above. Patient will be recalled after 1 week for re-evaluation and assessment followed by 3 months and 6 months. |