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临床试验/CTRI/2025/10/096614
CTRI/2025/10/096614招募中不适用

Efficacy and Safety of Modification of Ward’s Incision Without Distal Release Versus Conventional Ward’s Incision in Surgical Extraction of Impacted Mandibular Third Molars: A Randomized Controlled Trial

ALL INDIA INSTITUTE OF MEDICAL SCIENCES BIBINAGAR HYDERABAD1 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2025年11月20日最近更新:

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
88
试验地点
1

研究概览

简要总结

This research project investigates the postoperative outcomes of two surgical flap designs, the conventional Ward’s incision and a modified version without a distal releasing incision for the extraction of impacted mandibular third molars. Surgical removal of these teeth is a routine procedure but often leads to complications such as pain, swelling, and restricted jaw movement (trismus). While the conventional Ward’s flap provides excellent surgical access, it may contribute to greater postoperative discomfort due to its extensive tissue reflection. A modified approach that eliminates the distal releasing incision has been proposed to reduce these complications while maintaining sufficient surgical access. However, there is a lack of high-quality comparative studies on this topic.

The primary objective of this study is to determine whether the modified Ward’s incision results in reduced postoperative morbidity compared to the conventional method. Secondary objectives include comparing pain lefvels, facial swelling, operative efficiency, and complication rates between the two techniques. The study will be conducted as a randomized controlled trial at the Department of Dentistry, AIIMS Bibinagar, involving 54 participants (27 in each group) aged 18–35 years. Patients will be randomly assigned to either the conventional or modified flap group, with outcomes assessed at multiple time points post-surgery.

The findings are expected to provide evidence-based recommendations for oral surgeons, potentially improving patient comfort and recovery after third molar surgery. By addressing a gap in current research, this study could influence clinical practice by supporting the adoption of a less invasive flap design with comparable efficacy. Key measurements will include interincisal mouth opening (to assess trismus), pain scores using a visual analogue scale (VAS), and facial swelling through standardized linear measurements. Operative time, need for bone removal, and complications such as infection or dry socket will also be recorded. Statistical analysis will compare outcomes between groups, with adjustments for baseline differences. The study anticipates that the modified flap will lead to better postoperative recovery, including less trismus, reduced pain, and decreased swelling, without compromising surgical success

研究设计

研究类型
Interventional
分配方式
Randomized
盲法
Participant and Outcome Assessor Blinded

入排标准

年龄范围
18.00 Year(s) 至 65.00 Year(s)(—)
性别
All

入选标准

  • Adults aged 18–65 years, ASA I–II, indicated for surgical extraction of mesioangular impacted mandibular third molars (Pell & Gregory Class I/II, Position A/B), Pedersen difficulty 4–6, consent obtained.

排除标准

  • Deep bony impactions, acute infection, systemic diseases affecting healing, pregnancy/lactation, allergy to study medications, prior surgery at site.

研究者

发起方
ALL INDIA INSTITUTE OF MEDICAL SCIENCES BIBINAGAR HYDERABAD
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

Frijo Xavier

All India Institute of Medical Sciences (AIIMS) BIBINAGAR, HYDERABAD

研究点 (1)

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