| CTRI Number |
CTRI/2024/08/073096 [Registered on: 29/08/2024] Trial Registered Prospectively |
| Last Modified On: |
26/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Dentistry |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study on evaluating the healing after removing the tissue that connects upperlip to the gums with and without topical application of hyaluronic acid gel. |
|
Scientific Title of Study
|
COMPARATIVE EVALUATION OF WOUND HEALING WITH AND WITHOUT TOPICAL APPLICATION OF HYALURONIC ACID GEL POST FRENECTOMY USING ELECTROCAUTERY - A RANDOMIZED CONTROLLED 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 |
Roshan Arbaaz |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
Pondicherry University |
| Address |
Sixth floor,OPD no 602,Postgraduate clinic,Department of
Periodontology.
13A, Sri Venkateshwaraa Dental College,
PONDICHERRY
Pondicherry
PONDICHERRY
605012
India |
| Phone |
9940874915 |
| Fax |
|
| Email |
roshanarbaaz8@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr S Senthilnathan |
| Designation |
Professor and HOD |
| Affiliation |
SRI VENKATESHWARAA DENTAL COLLEGE |
| Address |
sixth floor,OPD no 602,Postgraduate clinic,Department of
Periodontology.13A Sri Venkateshwaraa Dental College
Pondicherry- villupuram main road Ariyur Puducherry
Pondicherry
PONDICHERRY
605012
India |
| Phone |
9443133088 |
| Fax |
|
| Email |
principal@svdcpondy.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Roshan Arbaaz |
| Designation |
POST GRADUATE STUDENT |
| Affiliation |
SRI VENKATESHWARAA DENTAL COLLEGE |
| Address |
Sixth floor,OPD no 602,Postgraduate clinic,Department of
Periodontology.13A, Sri Venkateshwaraa Dental College,
Pondicherry
Pondicherry
PONDICHERRY
605012
India |
| Phone |
9940874915 |
| Fax |
|
| Email |
roshanarbaaz8@gmail.com |
|
|
Source of Monetary or Material Support
|
| sixth Floor,OPD
no.602,postgraduate
clinic,Department of
Periodontology .13A,
Pondicherry -
Villupuram Road ,Ariyur
,Pondicherry |
|
|
Primary Sponsor
|
| Name |
DrBRoshan Arbaaz |
| Address |
13A Sri Venkateshwaraa Dental College Villupuram
main road Ariyur Pondicherry |
| 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 B Roshan arbaaz |
Sri Venkateshwaraa dental college |
Sixth floor, Department of Perioodntology,
13 A villupuram main road , ariyur,pondicherry 605102
Pondicherry
PONDICHERRY |
9940874915
roshanarbaaz8@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Venkateshwaraa Medical College Hospital and Research Centre, Institutional Ethical Committee ( Human Studies) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Z408||Encounter for other prophylactic surgery, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
frenectomy |
frenectomy with hyaluronic acid gel and frenectomy alone |
| Comparator Agent |
Hyaluronic acid gel |
frenectomy with hyaluronic acid gel - test group evaluation for 7 days
frenectomy alone - control group |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects within age group of 18 to 60 years.
Good oral hygiene at the time of the surgery.
Only maxillary anterior frenum were included in this study.
All subjects were systemically healthy.
|
|
| ExclusionCriteria |
| Details |
poor oral hygiene
pregnant and lactating mothers
chronic smokers
those were taking medications that affect the outcome of disease
patients with systemic conditions |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| to assess wound healing with healing index(Landry et al ) |
7th day,14th day,21st day,28th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| to assess postoperative pain using VAS scale |
7th day,14th day,21st day,28th day |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
12/09/2024 |
| 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="0"
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
|
In periodontology, frenectomy is mainly done to relive frenum pull of the upper lip to treat gum recession periodontal pocket closure of gap in upper front teeth Recently, prominence has been given to the use of hyaluronic-acid (HA) gel for cosmetic and medical reasons. HA is a high molecular weight, non-sulphated polysaccharide component of the family of the glycosaminoglycans, present in various body fluids such as synovial fluid, serum, saliva and gingival crevicular fluid . In dentistry, HA gel has been used for the acceleration of the healing process in tooth sockets, the treatment of temporomandibular joint osteoarthritis maintaining space in non-grafted sinus lifting, gingivitis, post laser assisted frenectomy and the management of soreness of recurrent aphthous ulceration. In periodontology, HA gel has been advocated as monotherapy or as an adjunct to non-surgical and/or surgical periodontal treatment to reduce inflammation and promote wound healing after frenectomy procedure.In comparing the efficacy of topical application of hyaluronic acid gel for wound healing following electrocautery frenectomy techniques.If proofed found effective,the HA gel may be routinely used for enhancing wound healing after frenectomy. |