Surgical Difficulty and Operation Time as Determinants of Outcomes in Mandibular Third Molar Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Total score on a 20-item postoperative patient satisfaction questionnaire following surgical extraction of impacted mandibular third molars
研究概览
简要总结
This prospective observational cohort study is designed to evaluate early postoperative complications and patient-reported satisfaction following surgical extraction of impacted mandibular third molars under local anesthesia in adult patients. Standardized surgical and postoperative protocols are applied to all participants. The primary objective is to assess overall patient satisfaction on postoperative day 7 using a structured questionnaire. Secondary objectives are to describe the frequency and characteristics of early postoperative pain, swelling, trismus and other complications in the first postoperative week after surgery.
详细描述
Adult patients requiring surgical removal of an impacted mandibular third molar under local anesthesia will be prospectively enrolled at a single oral and maxillofacial surgery center. All procedures will be performed using a standardized surgical technique and a uniform postoperative medication and care protocol. Clinical examinations and patient-reported outcome measures will be obtained at baseline and at the postoperative day-7 follow-up visit. The study focuses on describing the early postoperative course after third molar surgery and on exploring how early complications relate to overall patient satisfaction with treatment.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 15 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of one impacted mandibular third molar indicated for surgical extraction
- •Surgical removal of the impacted mandibular third molar planned under local anesthesia
- •Good general health (ASA I-II)
- •Ability to understand the study information and provide written informed consent
- •Willingness and ability to attend the postoperative day-7 follow-up visit and to complete all study questionnaires
排除标准
- •Systemic diseases corresponding to ASA III or higher
- •Acute infection at the surgical site (e.g. acute pericoronitis, abscess) requiring emergency treatment
- •Previous surgical intervention at the same mandibular third molar region
- •Pregnancy or lactation
- •History of radiotherapy or chemotherapy involving the head and neck region
- •Known bleeding disorders or current use of anticoagulant medication that cannot be safely modified for surgery
- •Chronic use of systemic corticosteroids, immunosuppressive drugs, or long-term analgesic therapy that may interfere with pain assessment or healing
- •Known allergy or contraindication to the local anesthetic or routinely used postoperative medications in this study
- •Significant cognitive or psychiatric disorders, or language barriers that prevent reliable completion of the questionnaires
结局指标
主要结局
Total score on a 20-item postoperative patient satisfaction questionnaire following surgical extraction of impacted mandibular third molars
时间窗: day 7
Patient satisfaction will be assessed on postoperative day 7 using a 20-item postoperative mandibular third molar surgery patient satisfaction questionnaire. The questionnaire evaluates domains such as pain control, swelling, mouth opening, intraoperative and postoperative comfort, information provided by the surgeon, ability to chew and perform daily activities, willingness to undergo the procedure again, and overall satisfaction with care. Each item is rated on a 5-point Likert-type scale (1 = lowest satisfaction, 5 = highest satisfaction). A total satisfaction score will be calculated by summing all item scores, resulting in a minimum total score of 20 and a maximum total score of 100.
次要结局
- Incidence and severity of early postoperative complications after surgical extraction of impacted mandibular third molars(day 7)
研究者
Dilara KAZAN
assistant prof
Bahçeşehir University