| CTRI Number |
CTRI/2026/02/104639 [Registered on: 24/02/2026] Trial Registered Prospectively |
| Last Modified On: |
09/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A study on the effect of hyaluronic acid gel on wound healing after gum surgery |
|
Scientific Title of Study
|
Effect of hyaluronic acid on wound healing in Free Gingival Graft (FGG) and estimation of Transforming Growth Factor Beta-1(TGF B1)levels in palatal wound fluid -A Randomised controlled 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.Haritha .M |
| Designation |
Post graduate |
| Affiliation |
Karpaga vinayaga institute of dental sciences |
| Address |
3rd floor , Department of periodontology , Karpaga Vinayaga Institute Of Dental Sciences , GST road , Chinnakolambakkam,Maduranthagam T.K ,Kancheepuram ,Tamil Nadu -603308,India.
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9789902226 |
| Fax |
|
| Email |
harithaperio13@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr . Hemalatha R |
| Designation |
Professor and Guide |
| Affiliation |
Karpaga vinayaga institute of dental sciences |
| Address |
3 rd floor , Department of periodontology , Karpaga Vinayaga Institute Of Dental Sciences , GST road , Chinnakolambakkam,Maduranthagam T.K ,Kancheepuram ,Tamil Nadu -603308,India.
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9884970030 |
| Fax |
|
| Email |
hemaarun21@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr. Haritha . M |
| Designation |
Post graduate |
| Affiliation |
Karpaga vinayaga institute of dental sciences |
| Address |
3rd floor , Department of periodontology , Karpaga Vinayaga Institute Of Dental Sciences , GST road , Chinnakolambakkam,Maduranthagam T.K ,Kancheepuram ,Tamil Nadu -603308,India.
Kancheepuram
TAMIL NADU
603308
India |
| Phone |
9789902226 |
| Fax |
|
| Email |
harithaperio13@gmail.com |
|
|
Source of Monetary or Material Support
|
| 3rd floor , Department of periodontology , karpaga vinayaga Institute of Dental Sciences , GST road , chinnakolambakkam,madhuranthagam T.K, Chengalpattu DT , India
603308 |
|
|
Primary Sponsor
|
| Name |
Dr Haritha M |
| Address |
3rd floor , Department of periodontology , karpaga vinayaga Institute of Dental Sciences , GST road , chinnakolambakkam,madhuranthagam T.K, Chengalpattu DT Madhuranthagam 603308 |
| 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 Haritha M |
Karpaga vinayaga institute of dental science |
Room no :7, Department of periodontology , 3rd floor ,chinnakolambakkam
Kancheepuram
TAMIL NADU |
9789902226
harithaperio13@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: T788||Other adverse effects, not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Hyaluronic acid gel |
cross linked hyaluronic acid gel , 1ml topical application on donor and 1 ml in topical application recepient site ,one time application |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Systemically healthy individuals
Age ranging between 18 and 40 years
Mucogingival problems indicating treatment by free gingival graft with no pathology or morphological alterations of palatal mucosa
Miller’s class two recession in anterior region
Keratinized width less than two millimeter in at least one of four mandibular incisors
|
|
| ExclusionCriteria |
| Details |
Caries or non carious cervical lesion at recipient sites
Severely malpositioned teeth
Teeth with residual probing depth more than four millimeter , mobility more than one millimeter
Vertical bone loss,smokers,or former smokers
Pregnant or lactating women
Systemic disease or any other condition that impair gingival healing
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Wound healing of donor site and recipient site |
At baseline , 1 month ,3 month ,6 month post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Transforming growth factor beta -1 levels in palatal wound fluid & visual analog scale |
At 7 th day , 14 th day post operatively |
|
|
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 3 |
|
Date of First Enrollment (India)
|
02/03/2026 |
| 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="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
This study is a randomized ,parallel group active controlled trial evaluating the effect hyaluronic acid gel in free gingival graft procedure using transforming growth factor beta 1 levels . The primary outcome will be soft tissue evaluation at 1 month , 3 month , 6 months after procedure .The secondary outcome will be quantitative levels of transforming growth factor beta 1 and visual analog scale at 7 th day and 14th day.
|