| CTRI Number |
CTRI/2021/03/031964 [Registered on: 15/03/2021] Trial Registered Prospectively |
| Last Modified On: |
08/02/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of TPRF, LPRF and Open flap debridement in treating upper and lower jaw bony defects in adult patients with gum diseases |
|
Scientific Title of Study
|
Comparative evaluation of open flap debridement , leukocyte rich platelet rich fibrin and titanium platelet rich fibrin in the treatment of three walled intrabony defects in Stage II and Stage III Periodontitis: A clinical study.
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Gowri Pendyala |
| Designation |
Reader |
| Affiliation |
Pravara Institute of Medical sciences |
| Address |
Department of Periodontics
Rural Dental College
Pravara Institute of Medical Sciences, Loni BK, Tal: Rahata , Dist :Ahmednagar, Maharashtra
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
7709254916 |
| Fax |
912422273413 |
| Email |
gowri.pendyala@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrAmeet Mani |
| Designation |
HOD and Professor |
| Affiliation |
Rural Dental College, Pravara Institute of Medical Sciences |
| Address |
Department of Periodontics
Rural Dental College
Pravara Institute of Medical Sciences, Loni BK, Tal: Rahata , Dist :Ahmednagar, Maharashtra
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
9545612345 |
| Fax |
912422273413 |
| Email |
ameetmani2007@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Gowri Pendyala |
| Designation |
Reader |
| Affiliation |
Rural Dental College, Pravara Institute of Medical Sciences |
| Address |
Department of Periodontics
Rural Dental College
Pravara Institute of Medical Sciences, Loni BK, Tal: Rahata , Dist :Ahmednagar, Maharashtra
Ahmadnagar
MAHARASHTRA
413736
India |
| Phone |
7709254916 |
| Fax |
912422273413 |
| Email |
gowri.pendyala@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rural Dental College, Pravara Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
DrGowri Pendyala |
| Address |
Department of Periodontics
Rural Dental College Loni |
| Type of Sponsor |
Other [self funded] |
|
|
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 |
| DrGowri Pendyala |
Rural dental college |
Department of Periodontics ,404, Rural Dental College , Pravara Institute of Medical Sciences , Loni Dist Ahmednagar 413736 Maharashtra
Ahmadnagar
MAHARASHTRA |
7709254916
gowri.pendyala@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee, Pravara Institute of Medical Sciences[Deemed University] |
Approved |
|
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Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
1)TPRF 2)LPRF |
1) T PRF preparation - centrifuge rotations 3000rpm for 10 min using titanium tubes
2) LPRF preparation centrifuge rotations 3000rpm for 10min using silica tubes |
| Intervention |
Group I,II,III each having 25 sites |
Group I-control Group wherein open flap debridement will be done
Group II- wherein TPRF is placed at the site
Group III- wherein LPRF is placed at the site |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients with stage II and stage III Periodontitis with presence of 3 walled intrabony defects of 3mm along with probing depth of 5mm and Clinical Attchment loss greater than or equal to 3mm when evaluated 8 weeks after phase I therapy on atleast 3 teeth |
|
| ExclusionCriteria |
| Details |
Patients with systemic diseases, blood dyscrasiasis, plaque index >1.5 afetr phase I therapy,pregnant and lactating, alcohol and tobacco consumption, nonvital teeth , mobile and furcation defects |
|
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Method of Generating Random Sequence
|
Permuted block randomization, variable |
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Method of Concealment
|
Case Record Numbers |
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Blinding/Masking
|
Participant and Outcome Assessor Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
| bone defect fill |
1,3,6,9 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
decrease in Probing depth,
gain in clinical attachment level, reduction in plaque index, reduction in modified sulcus bleeding index |
1,3,6,9 months |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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 3 |
|
Date of First Enrollment (India)
|
15/03/2021 |
| 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="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
Publication Details
Modification(s)
|
Not applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
Brief Summary
Modification(s)
|
The present clinical trial will be a PhD dissertation that is to be carried out at Department of Periodontics , Rural Dental College, PMT, PIMS, Loni -BK. Background: The platelet derived growth factors have shown promising results in regenerative periodontal procedures. The present study is carried out to see the clinical effect of T-PRF and L-PRF in the formation of bone in 2 walled and 3 walled intrabony defects in Stage II and Stage III Periodontitis Patients after a follow up of 1,3,6,9 months in healthy individuals of 20 to 55 years age group |