| CTRI Number |
CTRI/2024/05/067711 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
11/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A gum condition known as a furcation involvement. we are going to treat this with a special synthetic bone material combined with your own blood components |
|
Scientific Title of Study
|
Clinical and radiogrphical evaluation of Novabone porous granules with Autologus Fibrin Glue and Concentrated Growth Factor in treatment of furcation defect. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Riddhika Kochar |
| Designation |
PG student |
| Affiliation |
KM Shah Dental College, Sumandeep Vidyapeeth University Vadodara |
| Address |
Room no- 7, K M Shah Dental College and Hospital, Piparia-391760
Vadodara
GUJARAT
391760
India |
| Phone |
8975953131 |
| Fax |
|
| Email |
riddhikakochar23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Jasuma Rai |
| Designation |
Professor in Department of Periodontology |
| Affiliation |
K M Shah Dental College and Hospital |
| Address |
K M Shah Dental College and Hospital Piparia-391760
Vadodara
GUJARAT
391760
India |
| Phone |
9974005760 |
| Fax |
|
| Email |
drjasumaj@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jasuma Rai |
| Designation |
Professor in Department of Periodontology |
| Affiliation |
|
| Address |
Room no- 7, K M Shah Dental College and Hospital Piparia-391760
GUJARAT
391760
India |
| Phone |
9974005760 |
| Fax |
|
| Email |
drjasumaj@gmail.com |
|
|
Source of Monetary or Material Support
|
| KM Shah Dental College & Hospital |
|
|
Primary Sponsor
|
| Name |
Riddhika kochar |
| Address |
Room no- 7, K M Shah Dental College and Hospital Piparia-391760 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Riddhika Kochar |
KM Shah Dental College, Sumandeep Vidyapeeth University Vadodara |
Room no- 7, K M SHAH DENTAL COLLEGE AND HOSPITAL PIPARIA-391760
Vadodara
GUJARAT |
8975953131
riddhikakochar23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Concentrated Growth Factor |
Concentrated Growth Factor, a third-generation platelet concentrate, has a complex 3-dimensional architecture, fibrinogen containing platelets with a higher amount of cytokines, leukocytes, and growth factors which helps in regenration. |
| Intervention |
Novabone Porous Particle + Autologus Fibrin Glue |
Novabone Porous is an osteoconductive material. It is a one-component, resorbable bone void filler composed of a synthetic calcium phospho-silicate (Bioglass) particulate, fused into a bulk porous form having a multidirectional interconnected porosity. It act as a scaffold, with new bone infiltrating the porous structure. NovaBone Porous is progressively resorbed and replaced by new bone tissue during the healing process. Autologus Fibrin Glue serves as a hemostatic barrier and a scaffold for fibroblast that are migrating. Mesenchymal cells are stimulated and angiogenesis is induced and encouraged. Its biocompatibility provide stability to the bone graft material inside the defect. This promoted tissue repair and lowers bone resorption while the body heals.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients with a radiolucency in the furcation area on IOPA with probing depth (PD) ≥ 5mm and horizontal PD ≥ 3mm..
ï‚· Patients with Generalized Periodontitis Stage II & III with grade II, III furcation defect.
ï‚· Dentition with minimum 20 natural teeth with periodontitis with furcation involvement in molars
ï‚·Non-mobile teeth
ï‚·If any RC treated tooth is present, treatment must have completed before 3 months of the commencement of the study. |
|
| ExclusionCriteria |
| Details |
ï‚·Patients who were on antibiotic prophylaxis before the periodontal examination.
ï‚·Patients with systemic disease.
ï‚·Pregnant and Lactating women
ï‚·Participant with habit of smoking bidi or cigarettes, chewing tobacco or betel nut.
ï‚·Patient not giving consent.
|
|
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Method of Generating Random Sequence
|
Computer generated randomization |
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Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
ï‚·Probing depth
ï‚·Radiographic Defect Depth (RDD)
ï‚·Bone fill
ï‚·Bone density
|
Baseline and 9 months
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
ï‚·Plaque index
ï‚·Modified Gingival index
ï‚·Vertical Attachment Level (VAL)
ï‚· Horizontal Attachment Level (HAL) |
Baseline and 9 months |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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 4 |
|
Date of First Enrollment (India)
|
01/07/2024 |
| 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) |
Other (Terminated) |
|
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
Modification(s)
|
The reason for this termination of the clinical study is due to feasibility issues and time constraints encountered in the execution of the research.
|