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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  
NIL 
 
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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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