| CTRI Number |
CTRI/2023/08/057143 [Registered on: 31/08/2023] Trial Registered Prospectively |
| Last Modified On: |
09/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Treatment of intrabony defects |
|
Scientific Title of Study
|
Comparative evaluation of Platelet Rich Fibrin (PRF) and Titanium-Platelet Rich Fibrin (T-PRF) in the Treatment of Intrabony defects using 1% Metformin gel - A Clinical Study. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Raaja Sreepathy CS |
| Designation |
Post Graduate Student |
| Affiliation |
Sri Venkateswara Dental College and Hospital |
| Address |
Sri Venkateswara Dental College and Hospital, Off OMR Road, Near Navalur, thalambur, Chennai -600130
Kancheepuram
TAMIL NADU
600130
India |
| Phone |
9042503068 |
| Fax |
|
| Email |
csraaja@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Shanmugapriya R |
| Designation |
Professor |
| Affiliation |
Sri Venkateswara Dental College and Hospital |
| Address |
Sri Venkateswara Dental College and Hospital, Off OMR Road, Near Navalur, thalambur, Chennai -600130
Chennai
TAMIL NADU
600130
India |
| Phone |
9003286399 |
| Fax |
|
| Email |
drshanpriya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Raaja Sreepathy CS |
| Designation |
Post Graduate Student |
| Affiliation |
Sri Venkateswara Dental College and Hospital |
| Address |
Sri Venkateswara Dental College and Hospital, Off OMR Road, Near Navalur, thalambur, Chennai -600130
Chennai
TAMIL NADU
600130
India |
| Phone |
9042503068 |
| Fax |
|
| Email |
csraaja@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Raaja Sreepathy CS |
| Address |
Sri Venkateswara Dental College and Hospital, Off OMR road, Near Navalur, Thalambur, Chennai- 603103 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| Dr Shanmugapriya Ramamurthy |
Sri Venkateswara Dental College and Hospital, Off OMR road, Near Navalur, Thalambur, Chennai- 603103 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Raaja Sreepathy CS |
Sri Venkateswara Dental College and Hospital |
Room no 7, Department of Periodontics and Implantology, Sri Venkateswara Dental College and Hospital, Off OMR road, Near Navalur, Thalambur, Chennai- 600130
Kancheepuram
TAMIL NADU |
9042503068
csraaja@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Comittee - SVDCH |
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 |
PRF (Platelet Rich Fibrin) |
PLATELET RICH FIBRIN WITH 1% METFORMIN GEL
One and half Years |
| Intervention |
TPRF(Titanium Platelet Rich Fibrin) |
Titanium Platelet Rich Fibrin with 1% Metformin Gel
One and half Years |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Apparently healthy individuals.
2. Presence of Intrabony defect (IBD) depth ≥3 mm and interproximal probing depth (PD) ≥5 mm after phase I therapy. |
|
| ExclusionCriteria |
| Details |
1. HISTORY OF :
Aggressive Periodontitis. Smoking and tobacco use. Systemic conditions known to affect the periodontal status. Medications known to affect the gingival condition
2. Pregnant or lactating women.
3. Hematological disorders and insufficient platelet count after re-evaluation of Phase I therapy.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
clinical outcome assessment.
1. PD- Probing Depth
2. RAL- Relative Attachment Level
3. GML – Gingival Marginal Level
|
Baseline, 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
radiographic parameters
1. Level of alveolar crest
2. Base of Intra Bony Defect
3. Defect fill |
All parameters are assessed at 0,3 & 6 months interval. |
|
|
Target Sample Size
|
Total Sample Size="26"
Sample Size from India="26"
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)
|
10/09/2023 |
| 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)
Modification(s)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [csraaja@gmail.com].
- For how long will this data be available start date provided 19-08-2023 and end date provided 19-08-2028?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
The aim of the present study is to compare the clinical and radiographic success rate of PRF and TPRF using 1% Metformin gel in Intrabony Defects among chronic Periodontitis patients of 30 to 60 years of age. A total sample of 26 sites will be selected according to the following inclusion and exclusion criteria or selection parameters: INCLUSION CRITERIA: 1.•Apparently healthy individuals.•Presence of Intrabony defect (IBD) depth ≥3 mm and interproximal probing depth (PD) ≥5 mm after phase I therapy. EXCLUSION CRITERIA: •HISTORY OF: Aggressive Periodontitis. Smoking and tobacco use. Systemic conditions are known to affect the periodontal status. Medications are known to affect the gingival condition. Pregnant or lactating women. Hematological disorders and insufficient platelet count after re-evaluation of Phase I therapy. The selected samples will be randomized into two groups with 13 samples each. Under local anesthesia access Flap will be reflected. Root planing, Debridement, and root biomodification will be done. Blood will be drawn from systemically healthy patients and will be centrifuged in desired RPM. Based on the test and control group; PRF AND T-PRF MIXED WITH 1% METFORMIN GEL will be placed in the defect site respectively. The flap will be approximated and sutured, periodontal dressing will be given. Post-operatively patients will be prescribed appropriate analgesics and antibiotics for 5 days and OHI will be reinforced. Both the groups will be followed up for the assessment of clinical and radiographic parameters at 0,3,6 months intervals. The above-obtained data will be statistically analyzed.
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