| CTRI Number |
CTRI/2026/02/104186 [Registered on: 18/02/2026] Trial Registered Prospectively |
| Last Modified On: |
17/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Dentistry |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Clinical Trial to study effects of two medicated oral paste Triamcinolone acetonide and Amlexanox along with oral painkiller tablet for reducing pain and improving healing in patients after surgical release of upper lip-tie |
|
Scientific Title of Study
|
Comparative evaluation of Triamcinolone acetonide versus Amlexanox Oral Mucosal Paste as Adjuncts to Oral Dispersible Ketorolac Tromethamine for Control of Post-Operative Pain and Healing following Maxillary Labial Frenectomy using RF Electrocautery- A Randomized 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 Premjith P |
| Designation |
Postgraduate Student |
| Affiliation |
K.V.G Dental College and Hospital |
| Address |
Room No 11 Department Of Periodontology K V G Dental College and Hospital Sullia Dakshina Kannada
Dakshina Kannada KARNATAKA 574327 India |
| Phone |
9080835423 |
| Fax |
|
| Email |
drpremjith03@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Prakash Pai G |
| Designation |
Professor |
| Affiliation |
K.V.G Dental College and Hospital |
| Address |
Room No 11 Department Of Periodontolgy K V G Dental College and Hospital Sullia Dakshina Kannada
Dakshina Kannada KARNATAKA 574327 India |
| Phone |
9845156405 |
| Fax |
|
| Email |
prakashpaipai2014@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Prakash Pai G |
| Designation |
Professor |
| Affiliation |
K.V.G Dental College and Hospital |
| Address |
Room No 11 Department Of Periodontolgy K V G Dental College and Hospital Sullia Dakshina Kannada
Dakshina Kannada KARNATAKA 574327 India |
| Phone |
9845156405 |
| Fax |
|
| Email |
prakashpaipai2014@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Dr Premjith P |
| Address |
Room No 11 Department of Periodontology K V G Dental College and Hospital Sullia Dakshina Kannada Karnataka PIN:574327 |
| 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 Premjith P |
K V G Dental College and Hospital |
Room No 11 Department Of Periodontology K V G Dental College and Hospital Sullia Dakshina Kannada Karnataka PIN 574327 Dakshina Kannada KARNATAKA |
9080835423
drpremjith03@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE K V G DENTAL COLLEGE AND HOSPITAL |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: Q380||Congenital malformations of lips,not elsewhere classified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Amlexanox |
Amlexanox is a potent anti inflammatory, anti allergic and immunomodulatory agent approved by U.S Food and Drug Administration. It is available as 5% w/w concentration in 5 grams packaging. It is an oral medicated paste indicated for Recurrent Aphthous Stomatitis. It has cell membrane stabilization and inhibit release of histamine, TNF Alpha and Leukotriene. It contains mineral oil, pectin, gelatin, Sodium carboxymethylcellulose, benzyl alcohol and petrolatum that help the formulation adhere to the oral mucosa forming a protective film that resist washout by saliva. Dosage: Small amount of paste applied over the tissue surface 4 times daily (Q.I.D) for 7 days using a cotton swab |
| Intervention |
Triamcinolone acetonide |
Triamcinolone acetonide is a synthetic glucocorticoid approved by U.S Food and Drug Administration. It is available as 0.1% w/w concentration in 7.5 grams packaging. It is an oral mucosal paste indicated for Oral Inflammatory Lesions like Canker Sores and Recurrent apthous stomatitis. It suppress inflammatory mediator activity, including prostaglandin and leukotriene biosyntheis. It promote new epithelial formtion and suppress excessive granulation tissue formation and prevent progression to chronic wounds. It contains carboxymethylcellulose, gelatin and pectin to help the paste stick to mucosal surface. Dosage: Small amount of paste is applied over the tissue surface 3 times (T.I.D) daily for 7 days duration using a cotton swab
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Systemically healthy patients
2.Diagnosed as Papillary and Papillary Penetrating Maxillary Labial Frenal Attachment
3.Good Oral Hygiene
4.With written informed consent |
|
| ExclusionCriteria |
| Details |
1.Patients with Cardiac Pacemakers
2.Paients with Metallic implants
3.History of Peptic ulcer and Gastro Intestinal Bleed
4.Patients with Diabetes Mellitus and Hypertension
5.Pregnancy and Lactation
6.Patients on Systemic Steroids nad NSAIDs
7.Patients with pre-existing systemic infection
8.Smokers |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate and compare reduction in post operative pain between Group A receiving Triamcinolone Acetonide and Group B receiving Amlexanox Oral Mucosal paste |
6 hours, 3 days, 5 days and 7 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To compare and assess the reduction of post operative oedema and erythema between Group A receiving Triamcinolone acetonide and Group B receiving Amlexanox Oral Mucosal paste |
6 hours, 3 days, 5 days and 7 days |
| To assess intergroup comparison of wound healing at surgical site between Group A receiving Triamcinolone Acetonide and Group B receiving Amlexanox Oral Mucosal Paste |
6 hours, 3 days, 5 days and 7 days |
|
|
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)
|
01/05/2026 |
| 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="1" Months="8" 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
|
This study is a Randomized Controlled clinical trial designed to compare the effectiveness of Triamcinolone acetonide and Amlexanox oral mucosal paste as adjuncts to oral dispersible Ketorolac Tromethamine for control of postoperative pain and enhancement of wound healing following Maxillary labial frenectomy performed using radiofrequency electrocautery. Postoperative pain and delayed healing are common concerns after Frenectomy procedure using Radiofrequency electrocautery and may affect patient compliance and satisfaction. Although Ketorolac Tromethamine provide systemic analgesic action topical adjuncts offer localized protective barrier and targeted anti inflammatory action at the surgical site thereby reducing the need for increased systemic dosing. A total of twenty patients indicated for maxillary labial frenectomy will be randomly allocated into two groups in a 1 to 1 ratio. All participants will receive oral dispersible ketorolac tromethamine for postoperative analgesia. In addition Group A will receive topical triamcinolone acetonide oral mucosal paste and Group B will receive topical amlexanox oral mucosal paste applied over the sutured tissue surface as per protocol. The primary outcome measure will be postoperative pain assessed using a visual analogue scale at predetermined time intervals. Secondary outcome measures will include clinical evaluation of oedema erythema and wound healing using a standardized healing index. The study aims to determine which topical agent provides superior pain control and improved healing when used as an adjunct to standard analgesic therapy following frenectomy. The findings may help guide clinicians in selecting an effective postoperative management protocol with reduced systemic dosing of analgesic for patients undergoing maxillary labial frenectomy using radiofrequency electrocautery. |