| CTRI Number |
CTRI/2021/04/032650 [Registered on: 08/04/2021] Trial Registered Prospectively |
| Last Modified On: |
26/03/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To Assess The Effectiveness Of Injectable Platelet Rich Fibrin In Increasing Gingival Thickness |
|
Scientific Title of Study
|
Efficacy Of Injectable Platelet Rich Fibrin (i-PRF) In Increasing The Gingival Thickness:A Split Mouth Randomised Controlled 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 |
Manasa Budhan |
| Designation |
Post graduate student |
| Affiliation |
No.1958/1/Ac A/kuhs/2016 |
| Address |
Pms college of dental science and research ,
Department of Periodontics
Golden hills,Vencode.p.o,Vattappara,Trivandrum-695028.
Thiruvananthapuram
KERALA
695028
India |
| Phone |
7306028359 |
| Fax |
|
| Email |
manasabudhan59@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ambili R |
| Designation |
Professor |
| Affiliation |
No.1958/1/Ac A/kuhs/2016 |
| Address |
Pms college of dental science and research ,
Department of Periodontics
Golden hills,Vencode.p.o,Vattappara,Trivandrum-695028.
Thiruvananthapuram
KERALA
695028
India |
| Phone |
|
| Fax |
|
| Email |
ambiliranjith@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Manasa Budhan |
| Designation |
Post graduate student |
| Affiliation |
No.1958/1/Ac A/kuhs/2016 |
| Address |
Pms college of dental science and research ,
Department of Periodontics
Golden hills,Vencode.p.o,Vattappara,Trivandrum-695028.
Thiruvananthapuram
KERALA
695028
India |
| Phone |
7306028359 |
| Fax |
|
| Email |
manasabudhan59@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr.Manasa Budhan
Pms college of dental science and research ,
Department of Periodontics
Golden hills,Vencode.p.o,Vattappara,Trivandrum-695028.
|
|
|
Primary Sponsor
|
| Name |
Manasa Budhan |
| Address |
Pms college of dental science and research ,
Department of Periodontics
Golden hills,Vencode.p.o,Vattappara,Trivandrum-695028.
|
| Type of Sponsor |
Other [self funding] |
|
|
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 |
| Manasa Budhan |
Pms college of dental science and research |
Department of Periodontics
Clinic-3
Thiruvananthapuram
KERALA |
7306028359
manasabudhan59@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K051||Chronic gingivitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Injectable platelet rich fibrin(i-PRF) |
Injectable platelet rich fibrin(i-PRF) 0.2ml each will be injected to the attached gingiva using 30gauge X1/2 disposable insulin needle in relation to mandibular and/ or maxillary incisor on either left or right side depending on randomization. The injection will be done at 6 points that is A and B points at mesiobuccal, mid-buccal and distobuccal region of central and lateral incisors on the test side.Where
Point A is : Just apical to the free gingival groove
And Point B is : At the point just coronal to the muco-gingival junction.
The injection course is done only once and the patient is evaluated at the end of 3 and 6 months. |
| Comparator Agent |
No treatment |
Control site is kept free of treatmeant |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Healthy volunteers
Volunteers with thin gingival biotype according to aimetti et al classification 2008 ( 1mm thin;  1mm thick) in all maxillary incisors and/or mandibular incisors.
Non - smokers.
Periodontally and systemically healthy.
Good oral hygiene.
|
|
| ExclusionCriteria |
| Details |
Individual with insufficient platelet count(<200,000/cubic mm)
Pregnant and lactating women
Individuals undergoing orthodontic therapy
Presence of restorations in selected teeth
|
|
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Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gingival thickness |
At the day of procedure before injection(baseline) after 3 months and after 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Width of keratinized gingiva |
At the day of procedure before injection(baseline) after 3 months and after 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
|
Phase 1/ Phase 2 |
|
Date of First Enrollment (India)
|
20/04/2021 |
| 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="1"
Months="6"
Days="15" |
|
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
|
Gingival biotype is the quality of soft tissue profile surrounding the tooth.Base on gingival thickness(Aimetti et al classification,2008), gingival biotype can be thin gingival biotype(<1mm) and thick gingival biotype(>1mm).Gingival biotype is important for periodontal health,aesthetics and function,and is a predictor of periodontal and peri-implant treatments.Thin gingval biotype can lead to gingival recession as a result of traumatic brushing,orthodontic,restorative and periodontal treatment.Thin gingival biotype also lead to unpredictable post-operative soft tissue healing,graft failure and extensive bone resorption after tooth extraction.Gingival thickness can be enhanced by different methods.Connective tissue graft is the gold standard procedure, but it requires second surgical site and there is limited availability of tissue.Alternative options are acellular dermal matrix and use of platelet concentrates like Platelet rich Plasma (PRP) and Platelet rich Fibrin (PRF). Injectable Platelet rich Fibrin(i-PRF) is a modification of PRF developed in 2014 by lowering spin centrifugation forces in non-glass centrifugation tubes.Studies have reported enhanced gingival thickness with PRP and conventional PRF.The present study is to evaluate the gingival thickness after injection with i-PRF in healthy volunteers with thin gingival biotype.PROCEDURE: 0.2ml i-PRF will be injected at 6 points of central and lateral incisors on the test side.Contralateral side will be kept as control without i-PRF injection.Gingival thickness will be measured on the day of procedure before injection(baseline),at 3 months and 6 months follow up using a digital vernier calliper. |