| CTRI Number |
CTRI/2024/05/067384 [Registered on: 15/05/2024] Trial Registered Prospectively |
| Last Modified On: |
10/05/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Evaluating formation of lost bone formation by blood product |
|
Scientific Title of Study
|
Evaluation of Adjunctive Use of Titanium Reinforced Platelet Rich Fibrin With Demineralized Freeze Dried Bone Allograft in Grade II Furcation Treatment |
| 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 Bandaru Shanmukha Rao |
| Designation |
Post graduate student |
| Affiliation |
Vishnu Dental College |
| Address |
Block II, Room Number 7, Department of Periodontology, Vishnu Dental College.
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
8897755990 |
| Fax |
|
| Email |
drshan225@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mohan Kumar |
| Designation |
Associate professor |
| Affiliation |
Vishnu Dental College |
| Address |
Block II, Room Number 7, Department of Periodontology, Vishnu Dental College.
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
7799411140 |
| Fax |
|
| Email |
mosups@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Mohan Kumar |
| Designation |
Associate professor |
| Affiliation |
Vishnu Dental College |
| Address |
Block II, Room Number 7, Department of Periodontology, Vishnu Dental College.
West Godavari
ANDHRA PRADESH
534202
India |
| Phone |
7799411140 |
| Fax |
|
| Email |
mosups@gmail.com |
|
|
Source of Monetary or Material Support
|
| Vishnu Dental College, Vishnupur, Bhimavaram, Andhra pradesh, India 534202 |
|
|
Primary Sponsor
|
| Name |
Dr Bandaru Shanmukha rao |
| Address |
Block II, Room Number 7, Department of Periodontics, Vishnu Dental College. |
| 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 Bandaru Shanmukha Rao |
Vishnu Dental College |
Block II, Room Number 7, Department of Periodontology, Vishnu Dental college.
West Godavari
ANDHRA PRADESH |
8897755990
drshan225@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Vishnu dental college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Demineralized freeze dried bone allograft from TATA Memorial hospital, Mumbai |
Conventional periodontal Flap will surgery be Done followed by debridement and immediate placement of DFDBA(Demineralized freeze dried bone allograft from TATA Memorial hospital, Mumbai) in Grade II furcation defects. Clinical Evlauation will be done at 0 day,3 months , 6 months. |
| Intervention |
Titanium reinforced Platelet rich fibrin |
Conventional periodontal Flap will surgery be Done followed by debridement and immediate placement of DFDBA(Demineralized freeze dried bone allograft from TATA Memorial hospital, Mumbai) along with T-PRF in Grade II furcation defects. Clinical Evlauation will be done at 0 day,3 months , 6 months. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
Patients with Grade 2 furcation
Non smokers |
|
| ExclusionCriteria |
| Details |
Patients with uncontrolled systemic diseases
Pregnancy or Lactating women
Patients under anticoagulant therapy
Chronic smokers
Patients with infectious diseases
Patients undergoing radiation therapy |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Bone fill |
Baseline, 3 month, 6 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Gingival recession
2. Probing depth
3. Clinical attachment level |
Baseline, 3 month, 6 month |
|
|
Target Sample Size
|
Total Sample Size="11"
Sample Size from India="11"
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)
|
30/05/2024 |
| 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="2"
Months="0"
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
|
Patients visiting Vishnu Dental college with teeth having 2 or more bone loss in between roots of a teeth will be recruited. A written informed consent will be obtained from all the patient and blood will be collected from the patient. The teeth’s will be divided into two groups, Control and test group. In the control group teeth only DFBDA (bone graft) will be placed by rising a flap. In the Test group tooth, DFBDA along with T-PRF (a product developed by collecting 10 ml of blood) will be placed by rising a flap(Gingival tissue above the tooth).so additive effect of blood product (T-PRF) will be measured |