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临床试验/CTRI/2026/02/104186
CTRI/2026/02/104186尚未招募4 期

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

Dr Premjith P1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2026年5月1日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
20
试验地点
1

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 50.00 Year(s)(—)
性别
All

入选标准

  • 1.Systemically healthy patients 2.Diagnosed as Papillary and Papillary Penetrating Maxillary Labial Frenal Attachment 3.Good Oral Hygiene 4.With written informed consent.

排除标准

  • 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.

研究者

发起方
Dr Premjith P
申办方类型
Other [self]
责任方
Principal Investigator
主要研究者

Dr Premjith P

K.V.G Dental College and Hospital

研究点 (1)

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