| CTRI Number |
CTRI/2020/12/029879 [Registered on: 17/12/2020] Trial Registered Prospectively |
| Last Modified On: |
16/12/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
EFFECTIVENESS OF TITANIUM-PREPARED PLATELET RICH FIBRIN (T-PRF) IN TREATMENT OF PERIODONTAL DISEASE. |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF EFFECTIVENESS OF TITANIUM-PREPARED PLATELET RICH FIBRIN (T-PRF) IN COMBINATION WITH OPEN FLAP DEBRIDEMENT AND OPEN FLAP DEBRIDEMENT ALONE ASSESSED BY CONE BEAM COMPUTED TOMOGRAPHY IN TREATMENT OF PATIENTS WITH INTRABONY DEFECTS: A RANDOMIZED CLINICAL TRIAL. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrApeksha Sanjay |
| Designation |
Post graduate student |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Nagpur. |
| Address |
Room No. 5, Dept.of Periodontology,Swargiya Dadasaheb Kalmegh
Smruti Dental College And Hospital, Wanadongari,Waddhamna
Road, Hingna,District Nagpur.
Nagpur
MAHARASHTRA
441110
India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
09730099379 |
| Fax |
|
| Email |
agajghate.ag@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrApeksha Sanjay |
| Designation |
Post graduate student |
| Affiliation |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Nagpur. |
| Address |
Room No. 5, Dept.of Periodontology,Swargiya Dadasaheb Kalmegh
Smruti Dental College And Hospital, Wanadongari,Waddhamna
Road, Hingna,District Nagpur.
Nagpur
MAHARASHTRA
441110
India
Nagpur
MAHARASHTRA
441110
India |
| Phone |
09730099379 |
| Fax |
|
| Email |
agajghate.ag@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrSalman Ansari |
| Designation |
Reader, Dept.of Periodontology,Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital |
| Affiliation |
Dept.of Periodontology,Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital. |
| Address |
Room No. 5, Dept.of Periodontology,Swargiya Dadasaheb Kalmegh
Smruti Dental College And Hospital, Wanadongari,Waddhamna
Road, Hingna,District Nagpur.
Nagpur
MAHARASHTRA
441110
India
Room No. 5, Dept.of Periodontology,Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Nagpur.
Nagpur
MAHARASHTRA
441110
India |
| Phone |
9665063023 |
| Fax |
|
| Email |
dr.salmanansari@gmail.com |
|
|
Source of Monetary or Material Support
|
| Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital, Nagpur.
|
|
|
Primary Sponsor
|
| Name |
DrApeksha Gajghate |
| Address |
699,Dr Ambedkar nagar, Dharampeth, Nagpur-440010 |
| Type of Sponsor |
Other [] |
|
|
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 |
| DrApeksha Gajghate |
Swargiya Dadasaheb Kalmegh Smruti Dental College and Hospital |
Room no.5, Dept of Periodontology,Wanadongari-Wadhamna Road, Hingna,District Nagpur-441110 Nagpur MAHARASHTRA
Nagpur
MAHARASHTRA |
9730099379
agajghate.ag@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Committee Swargiya Dadasaheb Kalmegh Smruti Dental College And Hospital Nagpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A00-B99||Certain infectious and parasitic diseases, (2) ICD-10 Condition: K053||Chronic periodontitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Open flap debridement. |
Patients allocated to group having intrabony defects will be treated with open flap debridement alone. |
| Intervention |
Titanium prepared Platelet rich fibrin(T-PRF) |
Patients allocated to this group will be treated with titanium prepared platelet rich fibrin in combination with open flap debridement. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
1.Systemically healthy patients.
2.Patients with localized and generalized chronic periodontitis with three-walled intrabony defects.
3.Full mouth plaque scores should be less than 15 %.
|
|
| ExclusionCriteria |
| Details |
1.Patients who underwent periodontal therapy within 1 year.
2.Teeth indicated for extraction.
3.Patients having habit of consuming tobacco in any form.
4.Pregnant and lactating women.
5.Patients on any drug therapy which may affect the outcome of present study
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Probing Pocket Depth (PPD)
2.Relative Attachment level (RAL)
3.Gingival Recession (GR)
4.Plaque Index (PI) (Silness and Loe 1964)
5.Gingival Index (GI) (Loe and Silness 1963).
|
Pre-operatively and post-operatively at 6 months.
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of defect volume by Cone beam computed tomography (CBCT) |
pre-operatively and post-operatively at 6 months |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
18/12/2020 |
| 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="0"
Months="11"
Days="20" |
|
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)?
Response - NO
|
|
Brief Summary
|
This study is a randomized, Single blinded, parallel group trial comparing effectiveness of Titanium-prepared platelet rich fibrin in combination with open flap debridement and open flap debridement alone for 18-20 months in 30 patients with intrabony defects. It will be conducted in India. The primary outcomes to be measured are probing pocket depth (PPD), relative attachment level (RAL), gingival recession (GR), Plaque index (PI) and gingival index (GI) by assessing the vital parameters associated with chronic periodontitis and assessment of defect volume by Cone beam computed tomography (CBCT). |