| CTRI Number |
CTRI/2022/09/045601 [Registered on: 16/09/2022] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Preventive
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Gingival tissue augmentation using hyaluronic acid with or without micro-needling |
|
Scientific Title of Study
|
Comparative evaluation of gingival tissue augmentation using hyaluronic acid alone and with micro-needling : A randomized control trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR APOORVA G |
| Designation |
POSDT GRADUATE STUDENT |
| Affiliation |
KVG DENTAL COLLEGE AND HOSPITAL |
| Address |
POST GRADUATE STUDENT
DEPARTMENT OF PERIODONTOLOGY
ROOM NO 11
KVG DENTAL COLLEGE AND HOSPITAL
KURUNJIBAGH, SULLIA, DAKSHINA KANNADA
KVG DENTAL COLLEGE AND HOSPITAL, KURUNJIBAGH, SULLIA, DAKSHINA KANNADA 574327
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
8792246513 |
| Fax |
|
| Email |
dr.apoorva135@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR M M DAYAKAR |
| Designation |
PROFESSOR AND HEAD |
| Affiliation |
KVG DENTAL COLLEGE AND HOSPITAL |
| Address |
DEPARTMENT OF PERIODONTOLOGY
ROOM NO 11
KVG DENTAL COLLEGE AND HOSPITAL, KURUNJIBAGH, SULLIA, DAKSHINA KANNADA 574327
KVG DENTAL COLLEGE AND HOSPITAL, KURUNJIBAGH, SULLIA, DAKSHINA KANNADA 574327
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
8792246513 |
| Fax |
|
| Email |
mmdayakar@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
DR APOORVA G |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
KVG DENTAL COLLEGE AND HOSPITAL |
| Address |
POST GRADUATE STUDENT
DEPARTMENT OF PERIODONTOLOGY
ROON NO 11
KVG DENTAL COLLEGE AND HOSPITAL, KURUNJIBAGH, SULLIA, DAKSHINA KANNADA 574327
KVG DENTAL COLLEGE AND HOSPITAL, KURUNJIBAGH, SULLIA, DAKSHINA KANNADA 574327
Dakshina Kannada
KARNATAKA
574327
India |
| Phone |
8792246513 |
| Fax |
|
| Email |
dr.apoorva135@gmail.com |
|
|
Source of Monetary or Material Support
|
| KVG DENTAL COLLEGE AND HOSPITAL
ROOM NO 11
DEPARTMENT OF PERIODONTOLOGY
KURUNJIBAGH, SULLIA, DAKSHINA KANNADA 574327 |
|
|
Primary Sponsor
|
| Name |
KVG DENTAL COLLEGE AND HOSPITAL |
| Address |
KVG DENTAL COLLEGE AND HOSPITAL
DEPARTMENT OF PERIODONTOLOGY
ROON NO 11
KURUNJIBAGH, SULLIA, DAKSHINA KANNADA 574327 |
| Type of Sponsor |
Other [Private dental college] |
|
|
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 Apoorva G |
KVG dental college and hospital |
Department of Periodontology
Room no 11
Post graduate section
Kurunjibagh, sullia, dakshina
kannada, Pincode 574327
Dakshina Kannada
KARNATAKA |
8792246513
dr.apoorva135@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
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 |
Injectable hyaluronic acid filler along with microneedling |
0.1 ml of Injectable hyaluronic acid filler, local infiltration, once at baseline
30 gauge lancet needle for micro needling once only |
| Intervention |
injectable Hyaluronic acid fillers |
injectable Hyaluronic acid fillers 0.1 ml,local infiltration, once at base line |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy patients.
Mandibular anterior teeth <0.8 mm gingival thickness.
Full mouth plaque index and BOP score of <15 %
Gingival index < 1 % score.
|
|
| ExclusionCriteria |
| Details |
patient with known systemic disease.
Patient underwent treatment with antibiotics within last three months.
Patient who underwent treatment with anti-inflammatory drug within the last three months.
Patient undergoing orthodontic treatment.
Patient who underwent periodontal therapy within the last six months.
Pregnancy or use of oral contraceptive.
Smoking.
Patient using blood thinners.
Patient on medications which will lead to gingival enlargement.
Malocclusion.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To increase the gingival thickness |
Baseline
15 days
1 month
2 month
3 month
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| none |
none |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
Final Enrollment numbers achieved (Total)= "15"
Final Enrollment numbers achieved (India)="15" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
19/09/2022 |
| Date of Study Completion (India) |
31/03/2023 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
31/03/2023 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is a randomized, outcome assessor blinded, parallel group, single center trial comparing the efficacy of 0.1 ml of injectable hyaluronic acid filler on one side, injected just below the mucogingival junction and 0.1 ml of injectable hyaluronic acid filler with micro-needling using 30 gauge lancet needle which is inserted until hard tissue is felt on the keratinized gingiva from mesial side of the central incisor to the distal part of canine on other side after initial scaling 1 week prior to the commencement of the interventional study in patient with thin gingival biotype with <0.8mm of gingival thickness. The primary outcome is to assess the thickness of the keratinized gingiva after 15 days, 1 month, 2 month and 3 months after the treatment. |