| CTRI Number |
CTRI/2025/12/098272 [Registered on: 01/12/2025] Trial Registered Prospectively |
| Last Modified On: |
01/12/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Can using microneedling to stimulate blood flow in the gums, along with injectable and concentrated platelet-rich fibrin, help increase gum thickness
|
|
Scientific Title of Study
|
Comparative Evaluation Of
The Efficacy Of Microneedling With The Injectable Platelet- Rich Fibrin Versus Microneedling With The Concentrated Platelet-Rich Fibrin In The Management Of The Thin Gingival Phenotype - A Split
Mouth Randomized Clinical 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 Surabhi S Gowda |
| Designation |
PG student |
| Affiliation |
KVG Dental college and hospital |
| Address |
Room no 11 Department of Periodontology
KVG Dental college and hospital
Kurunjibagh Sullia
Dakshina Kannada Karnataka India
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
9916168982 |
| Fax |
|
| Email |
imsurabhigowda@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M M Dayakar |
| Designation |
Professor And The Head Of The Department |
| Affiliation |
KVG Dental college and hospital |
| Address |
Room no 11 Department of Periodontology
KVG Dental College and Hospital
Kurunjibagh Sullia
Dakshina Kannada Karnataka India
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
9448167427 |
| Fax |
|
| Email |
mmdayakar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M M Dayakar |
| Designation |
Professor And The Head Of The Department |
| Affiliation |
KVG Dental college and hospital |
| Address |
Room no 11 Department of Periodontology
KVG Dental college and hospital
Kurunjibagh Sullia
Dakshina Kannada Karnataka India
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
9448167427 |
| Fax |
|
| Email |
mmdayakar@yahoo.com |
|
|
Source of Monetary or Material Support
|
| KVG Dental college and hospital Kurunjibhag Sullia Dakshina Kannada Karnataka India-574327 |
|
|
Primary Sponsor
|
| Name |
Dr Surabhi S Gowda |
| Address |
Room no 11 Department of Periodontology
KVG Dental college and hospital
Kurunjibagh Sullia
Dakshina Kannada Karnataka India |
| 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 |
| Dr M M DAYAKAR |
KVG Dental College and Hospital |
Room no 11 Department of Periodontology KVG Dental College and Hospital
Kurunjibagh Sullia
Dakshina Kannada Karnataka India
Dakshina Kannada
KARNATAKA |
9448167427
mmdayakar@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee of KVG Dental College and Hospital |
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 |
| Comparator Agent |
Microneedling with the concentrated platelet rich fibrin.The procedure will be carried out after every 7 days for 3 sessions. |
1)11 patients with thin gingival phenotype will be treated with microneedling procedure with i-PRF and microneedling procedure with C-PRF will be divided based on chit method.
2)Group 1-11 patients with thin gingival phenotype will be treated with microneedling procedure with i-PRF in maxillary/mandibular anterior region.
3)Group 2-11 patients with thin gingival phenotype will be treated with microneedling procedure with C-PRF in maxillary/mandibular anterior region
Evaluation of the data will be based on the results.
|
| Intervention |
Microneedling with the injectable platelet rich fibrin.The procedure will be carried out after every 7 days for 3 sessions. |
1)11 patients with thin gingival phenotype will be treated with microneedling procedure with i-PRF and microneedling procedure with C-PRF will be divided based on chit method.
2)Group 1-11 patients with thin gingival phenotype will be treated with microneedling procedure with i-PRF in maxillary/mandibular anterior region.
3)Group 2-11 patients with thin gingival phenotype will be treated with microneedling procedure with C-PRF in maxillary/mandibular anterior region
Evaluation of the data will be based on the results.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients in the age group 18 to 45 years from both genders without any blood disorder willing to undergo treatment with informed consent were included
Sites with thin gingival phenotype gingival thickness less than 1 point 5mm in maxillary and mandibular canine and premolar region
Plaque index PI less than 1
Gingival index GI less than 1
Bleeding on probing score of less than 10 percent will be included in the study
|
|
| ExclusionCriteria |
| Details |
Patients undergoing active orthodontic treatment
Taking any medication that may cause gingival enlargement
Bruxism
Any previous history of periodontitis or periodontal therapy
Pregnant or lactating women
Use of tobacco in any form
Taking any blood thinners
Patients under Aspirin medication
Pre-existing mucogingival deformities
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Double Blind Double Dummy |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The aim of the study is to compare and evaluate the efficacy of microneedling with the injectable platelet-rich fibrin versus microneedling with the concentrated platelet-rich fibrin in the management of the thin gingival phenotype |
The outcome is assessed at baseline 3 months and 6 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)To assess the Gingival thickness following microneedling with i-PRF & microneedling with C-PRF in thin gingival phenotype.
2)To assess the Keratinized tissue width following microneedling with i-PRF & microneedling with C-PRF in thin gingival phenotype
3)To compare the Gingival thickness following microneedling with i-PRF & microneedling with C-PRF in thin gingival phenotype.
4)To compare the Keratinized tissue width following microneedling with i-PRF & microneedling with C-PRF in thin gingival phenotype. |
The outcome is assessed at baseline 3 months & 6 months |
|
|
Target Sample Size
|
Total Sample Size="11"
Sample Size from India="11"
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)
|
20/12/2025 |
| 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="1"
Months="6"
Days="1" |
|
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
|
The success of
restorative dental procedures and periodontal health are significantly
influenced by the gingival phenotype which is defined by gingival thickness GT and keratinized tissue width KTW Particularly vulnerable to gingival
recession cosmetic issues and a poor reaction to inflammatory or mechanical
stress are thin gingival phenotypes
Phenotype modification therapies PhMT have consequently become
increasingly important in contemporary dentistry Though they are thought to be
the best option traditional gingival augmentation techniques such connective
tissue grafts CTGs are invasive necessitate surgical skill and frequently have poor patient compliance
Micro needling MN and other minimally invasive procedures have become substitutes in recent
years Through regulated micro injuries microneedling increases the production
of collagen and promotes tissue regeneration whereas platelet rich fibrin PRF enhances tissue repair and regeneration by releasing growth factors
Advanced
variants of PRF such as injectable PRF i PRF and concentrated PRF C PRF are more successful at tissue regeneration because they contain larger
concentrations of platelets and leukocytes C PRF with its greater regenerative capacity has not been thoroughly compared to i PRF in the context
of thin gingival phenotypic alteration despite the fact that i PRF has been examined in
conjunction with microneedling
This study aims to compare the efficacy of
microneedling combined with i PRF versus microneedling combined with C PRF in modifying
thin gingival phenotypes By evaluating changes in gingival thickness and keratinized tissue width this research seeks to provide evidence for the most
effective minimally invasive approach to gingival augmentation |