| CTRI Number |
CTRI/2024/06/069332 [Registered on: 20/06/2024] Trial Registered Prospectively |
| Last Modified On: |
08/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Assessing the effects of a sticky gel with quercetin after laser surgery in the muscle attaching the upper lips and gums- A clinical trial |
|
Scientific Title of Study
|
Development of a Mucoadhesive gel with and without
quercetin and evaluation of its efficacy on the surgical wound
after laser frenectomy : A randomized clinical control 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 |
Roma Pandit |
| Designation |
Post Graduate |
| Affiliation |
SDM College of dental sciences and hospital |
| Address |
Department of Periodontology Room no. 7 SDM College of Dental Sciences and hospital Dharwad
F1 Kalburgi Seasons Apartments Shirur Park Road Vidyanagar
Dharwad
KARNATAKA
580021
India |
| Phone |
7022457882 |
| Fax |
|
| Email |
romapndit23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Swati Setty |
| Designation |
Proffesor and HOD |
| Affiliation |
SDM College of dental sciences and hospital |
| Address |
Department of Periodontology Room number 7 SDM College of Dental Sciences and hospital Dharwad
Dharwad
KARNATAKA
580021
India |
| Phone |
9845680773 |
| Fax |
|
| Email |
drssetty@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Swati Setty |
| Designation |
Proffesor and HOD |
| Affiliation |
SDM College of dental sciences and hospital |
| Address |
Department of Periodontology Room number 7 SDM College of Dental Sciences and hospital Dharwad
Dharwad
KARNATAKA
580021
India |
| Phone |
9845680773 |
| Fax |
|
| Email |
drssetty@gmail.com |
|
|
Source of Monetary or Material Support
|
| SDM College Of Dental Sciences and Hospital |
|
|
Primary Sponsor
|
| Name |
Roma Pandit |
| Address |
F1 Kalburgi Seasons Apartments Shirur Park Road Vidyanagar |
| Type of Sponsor |
Other [self funding] |
|
|
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 Swati Setty |
SDM College Of Dental Sciences and hospital |
Department of Periodontology Room no. 7 SDM College of Dental Sciences and hospital Dharwad
Dharwad
KARNATAKA |
09845680773
drssetty@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDMCDSH Institutional ethical committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K088||Other specified disorders of teethand supporting structures, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Mucoadhesive Gel |
Plain mucoadhesive gel without quercetin will be applied on the surgical wound for 5 days |
| Intervention |
Mucoadhesive gel with quercetin |
Quercetin incorporated mucoadhesive gel will be applied on the surgical wound for 5 days |
|
|
Inclusion Criteria
|
| Age From |
16.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
Patients with high abberant maxillary frenal attachment |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating women
Smokers
Individuals who have a history of antibiotic usage in the past 3 months
individuals who have been on anti-inflammatory drugs in the past 6 months |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Pre-numbered or coded identical Containers |
|
Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the effect of the mucoadhesive gel with quercetin on the surgical wound of laser frenectomy |
0 5th 7th 14th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To measure the wound dimensions post frenectomy
To evaluate the patients comfort and pain post surgery |
0 5th 7th 14th day |
|
|
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 2 |
|
Date of First Enrollment (India)
|
25/07/2024 |
| 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
|
Patients visiting the Department of Periodontics at SDMCDS&H will be recruited for a study on high maxillary frenal attachment, with 30 participants selected through convenience sampling and randomized into two groups. Group A will receive mucoadhesive gel with quercetin, and Group B will receive gel without quercetin. Laser frenectomy will be performed using a diode laser, and postoperative wound measurements will be assessed via ImageJ software. Patients will apply the gel twice daily for 5 days, with pain and discomfort evaluated at baseline, and on the 7th and 14th days using the visual analogue scale (VAS), and healing assessed using the Pippi modification of the Landry index. |