| CTRI Number |
CTRI/2024/04/065696 [Registered on: 15/04/2024] Trial Registered Prospectively |
| Last Modified On: |
14/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Reduction of scar and improvement of lip function by using injectable drugs. |
|
Scientific Title of Study
|
The role of triamcinolone acetonide and hyaluronidase injection in minimizing labial scarring and improving peri-oral function following intraoral vestibular incisions. |
| 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 Shipra Bharti |
| Designation |
Post Graduate Student |
| Affiliation |
SRM Dental College, Ramapuram |
| Address |
Department Of Oral and Maxillofacial Surgery
SRM Dental College
Ramapuram
Chennai
Chennai
TAMIL NADU
600089
India |
| Phone |
7264940428 |
| Fax |
|
| Email |
shiprabharti028@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Elavenil Pannerselvam |
| Designation |
Professor - Department Of Oral And Maxillofacial Surgery |
| Affiliation |
SRM Dental College, Ramapuram |
| Address |
SRM Dental College
Bharathi Salai
Ramapuram
Chennai
Chennai
TAMIL NADU
600089
India |
| Phone |
9841254653 |
| Fax |
|
| Email |
elavenilomfs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR ELAVENIL PANNEERSELVAM |
| Designation |
Professor - Department Of Oral And Maxillofacial Surgery |
| Affiliation |
SRM Dental College, Ramapuram |
| Address |
SRM Dental College
Bharathi Salai
Ramapuram
Chennai
Chennai
TAMIL NADU
600089
India |
| Phone |
9841254653 |
| Fax |
|
| Email |
elavenilomfs@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department 0f 0ral And Maxillofacial Surgery
SRM Dental College
Bharathi Salai
Ramapuram
Chennai |
|
|
Primary Sponsor
|
| Name |
Dr Shipra Bharti |
| Address |
SRM Dental College
Bharathi Salai
Ramapuram
Chennai |
| 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 Shipra Bharti |
SRM Dental College |
Department Of Oral and Maxillofacial Surgery
SRM Dental College, Bharathi Salai, Ramapuram
Chennai
TAMIL NADU |
7264940428
shiprabharti028@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRMDC INSTITUTIONAL REVIEW BOARD |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M268||Other dentofacial anomalies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Triamcinolone acetonide and hyaluronidase injection in minimizing labial scarring and improving peri-oral function following intraoral vestibular incisions. |
Study group -Injection of triamcinolone acetonide + hyaluronidase
Dosage - Triamcinolone acetonide 1ml (10mg/ml) + hyaluronidase 1ml(1,500 IU)
Route of administration -Submucosal
Frequency - Once a week
Total Duration - 8 weeks
Total number of administration -8 injections in 8 weeks
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1)Patients aged 20 to 50 years
2)Patients indicated for surgical procedures (orthognathic, trauma and pathology) requiring exposure of anterior maxilla or mandible by vestibular incision.
3)Patients categorized under ASA status I & II
|
|
| ExclusionCriteria |
| Details |
1)Patients with lacerations or pathological changes in the lip
2)Patients with infection in the surgical site
3)Patients categorized under ASA status III, IV
4)Patients lesser then 20years and greater than 50years
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)Pain by clinical evaluation, using Numerical pain rating scale
2)Tissue fibrosis, by biochemical evaluation of serum lactate Dehydrogenase
3)Tissue fibrosis by Ultrasonographic evaluation
|
1)1st 3rd & 7th preoperative day & 2nd to 8th postoperative week
2)Tissue fibrosis, by biochemical evaluation of serum lactate Dehydrogenase -preoperative and 8th postoperative week
3)Tissue fibrosis by Ultrasonographic evaluation- preoperative and 8th postoperative week
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Mouth opening in mm
2.Inter commissural distance (at rest, pursing & wide grin)
3.Lip elasticity index
4.Oral access
5.Healing of incision
6.Vestibular depth
|
1.Mouth opening – pre-op day,
1st to 8th post-op week
2.Lip movements - pre op
day,1st to 8th post-op week
3.Healing of incision -1st to
8th post-op week
4.Vestibular depth - pre op
day,1st to 8th post-op week
|
|
|
Target Sample Size
|
Total Sample Size="20"
Sample Size from India="20"
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 4 |
|
Date of First Enrollment (India)
|
28/04/2024 |
| 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="5"
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
|
Surgical procedures involving the maxillofacial skeleton require various incisions for exposure of surgical site. The most preferred approach is intra-oral, using a vestibular incision, for cosmetic reasons. However, this incision is associated with multiple complications such as infection, wound dehiscence, swelling, trismus and scarring. The fibrosis associated with vestibular incision specifically presents the following clinical problems; (1) impairment of normal lip movements (2) obliteration of vestibular depth which compromises prosthetic rehabilitation and (3) fibrotic bands especially in the anterior region, compromising the lower facial esthetics. Numerous methods have been employed to facilitate intraoral wound healing namely, cyano-acrylate based tissue adhesive, hyaluronic acid film, Pentoxifylline and injection of corticosteroids, hyaluronidase, & placentrix. However, there is a lacuna in literature regarding measures which prevent or minimize scarring associated with vestibular incision. The investigators of the study hypothesize that injection of triamcinolone acetonide & hyaluronic acid in the surgical site would reduce scarring associated with vestibular incision and improve lip function. |