| CTRI Number |
CTRI/2020/03/024204 [Registered on: 24/03/2020] Trial Registered Prospectively |
| Last Modified On: |
19/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Advanced platelet fibrin in alveolar bone formation |
|
Scientific Title of Study
|
Evalution of advanced platelet rich fibrin with open flap debridement in the regeneration of human periodontal intra-bony defects-A randomized clinical trail |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Bhagya123 |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
M Bhagya shree |
| Designation |
Postgraduate |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Department of Periodontology, room no.5,Narayana Medical college and hospital, Chinthareddypalem, Nellore-524003.
Nellore
ANDHRA PRADESH
530003
India |
| Phone |
9966509953 |
| Fax |
|
| Email |
bhagyashreemuppana.muppana@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vijay kumar Chava |
| Designation |
Head of the department and Professor |
| Affiliation |
Narayana Dental College and Hospital |
| Address |
Department of Periodontology, Room no. 5,Narayana Medical college and hospital, Chinthareddypalem, Nellore.
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9441978737 |
| Fax |
|
| Email |
chava7@hotmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Vijay kumar Chava |
| Designation |
Head of the department and professor |
| Affiliation |
Narayana dental college and hospital |
| Address |
Department of Periodontology, Room no. 5,Narayana Medical college and hospital, Chinthareddypalem, Nellore.
Nellore
ANDHRA PRADESH
524003
India |
| Phone |
9441978737 |
| Fax |
|
| Email |
chava7@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
M Bhagya shree |
| Address |
Department of Periodontology, Room no. 5,Narayana Dental College
Nellore |
| 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 |
| Vijay Kumar Chava |
Narayana dental college |
Department of Periodontology, room no.5, Narayana dental college,Chinthareddypalem.
Nellore
ANDHRA PRADESH |
9441978737
chava7@hotmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Narayana dental college |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
with intra bony defects |
| Patients |
(1) ICD-10 Condition: Z00-Z99||Factors influencing health status and contact with health services, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Periodontal Flap Surgery |
Surgical periodontal flap reflection, debridement and flap closure with sutures. |
| Intervention |
Periodontal Flap surgery |
Surgical reflection of periodontal flap, debridment of the defect and placement of Advanced Platelet Rich fibrin in bone defects, followed by closure of flap with sutures |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Diagnosed with intra-bony defects
More than 20 teeth present
Systemically healthy and not under antibiotics since past 6 months
Intra bony defect >3mm radiographicaly
Probing pocket depth >5mm |
|
| ExclusionCriteria |
| Details |
Systemic diseases that influence periodontal disease and therapy
Subjects who were on antibiotics in past six months
Pregnant and lactating women |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pocket probing depth, Relative clinical attachment level gain, plaque index, Modified sulcular bleeding index |
6months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Bone fill |
6months |
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 1 |
|
Date of First Enrollment (India)
|
26/03/2020 |
| 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
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
A randomized clinical rail will be conducted by the Department of Periodontology , NarayanaDental College and Hospital, Nellore, Andhra pradesh, India. A total of minimum 20 sites with intra-bony defects will be selected. After full mouth scaling and root planning selected participants will be randomized into following groups. Group A: Open flap debridement (OFD) Group B: Open flap debridement (OFD) with Advanced platelet rich fibrin (A-PRF) Plaque index, Modified sulcular bleeding index, Probing pocket depth, Relative attachment gain and radiographic bone fill will be done at baseline and 6 months. All the parameters willl be subjected for statistical analysis after completion of the study to evaluate the bone fill between the groups in intra-bony defect. |