| CTRI Number |
CTRI/2025/04/085912 [Registered on: 29/04/2025] Trial Registered Prospectively |
| Last Modified On: |
27/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
effect of injectable platelet rich fibrin on treatment of thin gingival biotype |
|
Scientific Title of Study
|
To assess and compare the efficacy of injectable platelet-rich fibrin and microneedling in treatment of thin gingival biotype – A randomized controlled 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 |
MANSI TAKALKAR |
| Designation |
post graduate student |
| Affiliation |
KAHERS KLE VK Institute of dental sciences |
| Address |
Department of periodontics, second floor KLE VK Institute of dental sciences,Neharu nagar, Belagavi
Belgaum
KARNATAKA
590010
India |
| Phone |
8007947722 |
| Fax |
|
| Email |
mstakalkar1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
MANSI TAKALKAR |
| Designation |
post graduate student |
| Affiliation |
KAHERS KLE VK Institute of dental sciences |
| Address |
Department of periodontics, second floor KLE VK Institute of dental sciences,Neharu nagar, Belagavi
KARNATAKA
590010
India |
| Phone |
8007947722 |
| Fax |
|
| Email |
mstakalkar1997@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MANSI TAKALKAR |
| Designation |
post graduate student |
| Affiliation |
KAHERS KLE VK Institute of dental sciences |
| Address |
Department of periodontics, second floor KLE VK Institute of dental sciences,Neharu nagar, Belagavi
KARNATAKA
590010
India |
| Phone |
8007947722 |
| Fax |
|
| Email |
mstakalkar1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Periodontics, KAHER’s KLE Vishwanath Katti Institute of Dental
Sciences, JNMC campus, Nehru Nagar, Belagavi-590010, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
MANSI TAKALKAR |
| Address |
DEPARTMENT OF PERIODONTICS, KLE VK INSTITUTE OF DENTAL SCIENCES, NEHARU NAGAR,BELAGAVI, INDIA, 590010 |
| 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 |
| Dr MANSI TAKALKAR |
KAHERS KLE VK INSTITUTE of dental sciences |
Department of periodontics, second floor KLE VK Institute of dental sciences,Neharu nagar, Belagavi
Belgaum
KARNATAKA |
08007947722
mstakalkar1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Research and Ethics Committee KLE VKIDS |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
THIN GINGIVAL BIOTYPE |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
INJECTABLE PLATELET RICH FIBRIN |
INJECTABLE PLATELETE RICH FIBRIN IS INJECTED INTO ATTACHED GINGIVA ALONG WITH MICRONEEDLING TO INCREASE GINGIVAL BIOTYPE FOR 3 MONTHS |
| Comparator Agent |
MICRONEEDLING ALONE |
MICRONEEDING IN ATTACHED GINGIVA TO IMPROVE GINGIVAL BIOTYPE |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Patients having thin gingival biotype that is less than 1mm in maxillary anterior region. those should have plaque index score 0 or 1. those without any other dental abnormality in maxillary anterior region. |
|
| ExclusionCriteria |
| Details |
Patients undergoing active orthodontic treatment
Patients with history of periodontal surgery
Patients with history of any systemic diseases
Patients on blood thinners
Patients using any drugs that might lead to gingival enlargement
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gingival thickness |
baseline, 1 month, 3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| keratinized tissue width |
baseline, 1 month, 3 months |
|
|
Target Sample Size
|
Total Sample Size="33"
Sample Size from India="33"
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)
|
26/05/2025 |
| 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)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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 - Statistical Analysis Plan
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 - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [mstakalkar1997@gmail.com].
- For how long will this data be available start date provided 15-11-2025 and end date provided 15-11-2030?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Gingival biotype has a role in various periodontal disease progression and outcome of several periodontal sugeries as well. Microneedling induces response similar to tissue trauma,
where body’s own collagen production is induced as a result of which production
of growth factors is increased which leads to proliferation of new cells and fibroblasts
transforming into collagen and elastin fibres from day 5 up to week 8. Fibroblasts also trigger neoangiogenesis and neocollagenesis which
may show additive effect with injectable PRF on thin gingival biotype.
Therefore, the current study aims to evaluate
the effectiveness of injectable
platelet-rich fibrin alone and along with microneedling technique on thin
gingival biotype. |