| CTRI Number |
CTRI/2024/04/065688 [Registered on: 15/04/2024] Trial Registered Prospectively |
| Last Modified On: |
03/07/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Surgical/Anesthesia
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
The effect of use of human blood derived platelet concentrate material for better adaptation of gums (gingiva) over exposed root surface of the tooth among people having receeding gums. |
|
Scientific Title of Study
|
Efficacy of injectable platelet rich fibrin (iPRF) as a root biomodification agent in the management of RTI gingival recession- a double blinded randomised control trial. |
| 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 Nivedha Nedumaran |
| Designation |
Post graduate |
| Affiliation |
Saveetha dental college and hospital, SIMATS University, Chennai |
| Address |
Clinic 25, 4th floor,
Department of Periodontics,
Saveetha dental college and hospital,
No 162, Poonamallee High Road,
Velappanchavadi , Chennai.
Kancheepuram
TAMIL NADU
600077
India |
| Phone |
9600177122 |
| Fax |
|
| Email |
152205003.sdc@saveetha.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nivedha Nedumaran |
| Designation |
Post graduate |
| Affiliation |
Saveetha dental college and hospital, SIMATS University, Chennai |
| Address |
Clinic 25, 4th floor,
Department of Periodontics,
Saveetha dental college and hospital,
No 162, Poonamallee High Road,
Velappanchavadi , Chennai.
Kancheepuram
TAMIL NADU
600077
India |
| Phone |
9600177122 |
| Fax |
|
| Email |
152205003.sdc@saveetha.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sankari Malaiappan |
| Designation |
Professor |
| Affiliation |
Saveetha dental college and hospital, SIMATS university |
| Address |
Clinic 25, 4th floor,
Department of Periodontics,
Saveetha dental college and hospital,
No 162, Poonamallee High Road,
Velappanchavadi , Chennai.
Kancheepuram
TAMIL NADU
600077
India |
| Phone |
9840285905 |
| Fax |
|
| Email |
sankari@saveetha.com |
|
|
Source of Monetary or Material Support
|
| Saveetha dental college and hospitals, Saveetha institute of medical and technical science, SIMATS university , Chennai, Tamil Nadu. |
|
|
Primary Sponsor
|
| Name |
Saveetha dental college and hospital SIMATS University |
| Address |
Clinic 25, 4th floor,
Department of Periodontics,
Saveetha dental college and hospital,
No 162, Poonamallee High Road,
Velappanchavadi , Chennai. |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Nivedha Nedumaran |
Saveetha dental college and hospital |
Clinic 25, 4th floor, department of periodontology, Saveetha dental college and hospital,
No 162, Poonamallee High Road, velappanchavadi, Chennai 600077
Kancheepuram
TAMIL NADU |
9600177122
152205003.sdc@saveetha.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Human Ethical Committee (SDC-IHEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K055||Other periodontal diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Coronally advanced flap + iPRF |
Coronally advanced flap with iPRF as a root biomodification agent done at the time of surgical procedure and evaluation done at baseline and 6months.
Total duration of the study - 6months |
| Comparator Agent |
Coronally advanced flap alone |
Coronally advanced flap to treat RTI gingival recession at the time of surgical procedure and evaluated at baseline and 6months.
Total duration of the study - 6months |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients with RT l gingival recession.
2 teeth with visible cementoenamel junction
3 subjects were at least 20 years old
4 participants who are periodontally healthy
5 General health status - ASA I and ASA II
|
|
| ExclusionCriteria |
| Details |
1 Smokers
2 subjects with cervical caries
3 probing depth more than 4mm
|
|
|
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 |
Probing depth, Clinical attachment level, Keratinised tissue gain, Gingival thickness, Recession width, Recession height, Mean root coverage
|
Baseline
6months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Pink esthetic score |
Baseline and 6months |
|
|
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
30/04/2024 |
| 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="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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 - NO
|
|
Brief Summary
|
Gingival recession is defined as apical migration of the gingival margin in the enamel-cement border towards the apex and subsequent exposure of the root surface . Among the several methods that have been developed to treat gingival recession, it is based on the case selection and material of choice that makes it success. Researchers have investigated the root coverage effects of various biomodification agents, including Emdogain, various root development regulators, laser treatments, growth factors, and thrombocyte-rich plasma. Injectable PRF (I-PRF) is the liquid form of PRF. I-PRF is a bioactive agent obtained by low-speed centrifugation, and it has the capacity to stimulate tissue regeneration. i-PRF is generally used in regenerative treatments, with good outcomes. One of the components that make up I-PRF is fibronectin which is an extracellular glycoprotein with a high molecular weight (approximately 440 kDa). Application of fibronectin to root surfaces improves cellular proliferation from the periodontal ligament towards the supracrestal parts. Hence the study was undertaken to evaluate the efficacy of i-PRF as a root biomodification agent in treatment of RT I gingival recession along with coronally advanced flap.
|