| CTRI Number |
CTRI/2025/01/078961 [Registered on: 17/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Medical Device Preventive Dentistry Other (Specify) [I-PRF and Hyaluronic acid gel will be injected to thin gingiva] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison of injectable platelet rich fibrin and hyaluronic acid with microneedling in thin gums. |
|
Scientific Title of Study
|
Comparative Evaluation Of Injectable - Platelet Rich Fibrin And Hyaluronic Acid with Microneedling In Thin Gingival Phenotype - A Split Mouth 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 |
Dr Praise Jose |
| Designation |
Post Graduate Student |
| Affiliation |
Coorg Institute of Dental Sciences |
| Address |
Department of Periodontics ,Room No. 4 ,Coorg Institute Of Dental Sciences KK Campus Maggula Village Virajpet Karnataka 571218 Department of Periodontics ,Room No. 4 ,Coorg Institute Of Dental Sciences KK Campus Maggula Village Virajpet Karnataka 571218 Kodagu KARNATAKA 571218 India |
| Phone |
7907195185 |
| Fax |
|
| Email |
praisjose@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Praise Jose |
| Designation |
Post Graduate Student |
| Affiliation |
Coorg Institute of Dental Sciences |
| Address |
Department of Periodontics ,Room No. 4 ,Coorg Institute Of Dental Sciences KK Campus Maggula Village Virajpet Karnataka 571218 Department of Periodontics ,Room No. 4 ,Coorg Institute Of Dental Sciences KK Campus Maggula Village Virajpet Karnataka 571218 Kodagu KARNATAKA 571218 India |
| Phone |
7907195185 |
| Fax |
|
| Email |
praisjose@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
RADHIKA B |
| Designation |
PROFESSOR |
| Affiliation |
Coorg Institute of Dental Sciences |
| Address |
Department of Periodontics ,Room No. 4 ,Coorg Institute Of Dental Sciences KK Campus Maggula Village Virajpet Karnataka 571218 Department of Periodontics ,Room No. 4 ,Coorg Institute Of Dental Sciences KK Campus Maggula Village Virajpet Karnataka 571218 Kodagu KARNATAKA 571218 India |
| Phone |
9742096982 |
| Fax |
|
| Email |
radika_b24@yahoo.co.in |
|
|
Source of Monetary or Material Support
|
| Coorg Institute Of Dental Sciences KK Campus Maggula Village Virajpet Karnataka 571218 |
|
|
Primary Sponsor
|
| Name |
Dr. Praise Jose |
| Address |
Coorg Institute Of Dental Sciences KK Campus Maggula Village Virajpet Karnataka 571218 |
| Type of Sponsor |
Other [SELF] |
|
|
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 |
| Praise Jose |
Coorg Institute of Dental Sciences |
Department of Periodontics ,Room No. 4 ,Coorg Institute Of Dental Sciences KK Campus Maggula Village Virajpet Karnataka 571218 Kodagu KARNATAKA |
7907195185
praisjose@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Review Board |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K069||Disorder of gingiva and edentulousalveolar ridge, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Hyaluronic acid and Microneedling |
Hyaluronic acid combined with microneedling injected at thin gingival phenotype of less than 1mm at 3mm below free gingival margin. |
| Intervention |
I-PRF and Microneedling |
I-PRF and Microneedling combined procedure done at thin gingival phenotype of less than 1mm at 3mm below free gingival margin until blanching is seen |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with thin gingival phenotype of less than 1mm, plaque and gingival index less than 1 and bleeding on probing less than 10% |
|
| ExclusionCriteria |
| Details |
Subjects who are systemically unhealthy, poor oral hygiene , pregnant and lactating mothers , alcoholics and smokers, patients undergoing active orthodontic treatment and patients taking any medication that cause gingival enlargement |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Increase in gingival thickness at anterior part of mandible with use of I-PRF and Microneedling |
Increase in gingival thickness at anterior part of mandible with use of I-PRF and Microneedling
Gingival thickness will be measured at baseline ,1 month and 3 month respectiveley.Both hyaluronic acid,microneedling and i-prf will be administered during baseline,1month and 3rd month. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Increase in gingival thickness at anterior mandible with use of Hyaluronic acid & Microneedling |
Gingival thickness will be measured using a digital caliper at baseline ,1 month & 3 month after procedure.Both hyaluronic acid,microneedling & i-prf will be administered at baseline 1 month & 3rd month. |
|
|
Target Sample Size
|
Total Sample Size="17" Sample Size from India="17"
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)
|
03/02/2025 |
| 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 - NO
|
|
Brief Summary
|
Depending on the size, texture, location, and shape of the gingiva and alveolar process, each person has a distinct “Gingival Phenotype†that affects their periodontal response to inflammation and course of therapy.Individuals with thin-phenotype are more likely to experience gingival recession in the context of trauma and inflammation.Conventionally, surgical techniques like subepithelial connective tissue grafting and other augmentation procedures such as modified roll technique and acellular dermal matrix were found to be useful .Since patients are reluctant in doing surgical procedures, it has come for the need of non-surgical therapies to enhance the gingival phenotype.Thus Microneedling, I-PRF and hyaluronic acid has been found to be an alternative choice for the treatment of thin gingival phenotype. Microneedling (MN) technique is a non-surgical procedure that is known as collagen induction therapy involving repetitive punctures on the skin. Over a petite period of time, it has expanded mass admiration and acceptance as it is a simple, inexpensive, and effective technique.PRF also induces higher fibroblast migration and expression of platelet-derived growth factor (PDGF), transforming growth factor B (TGF-B), and collagen-1 .Hyaluronic acid (HA), a naturally occurring polysaccharide, is considered an important component of the extracellular matrix in connective tissues of the human body.The unique biological and physiochemical properties of HA make it an interesting biomaterial for medical, cosmetic, and pharmaceutical applications. In light of these factors, due to the positive effects of HA, MN and I-PRF on the biological potential, neoangiogenesis, neocollagenesis and wound-healing, the aim of this study is meant to compare the clinical efficacy of micro-needling with I-PRF and HA in thin gingival phenotype. |