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临床试验/NCT05820867
NCT05820867已完成不适用

Prospective Comparison of Single vs. Staged Extractions: OHRQoL Outcomes for Wisdom Teeth Removal

Marmara University2 个研究点 分布在 1 个国家目标入组 59 人开始时间: 2018年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
59
试验地点
2
主要终点
Change from baseline oral health-related quality of life at 14 days

研究概览

简要总结

This single-center prospective cohort study includes patients aged 18-30 years aimed to compare the effects of bilateral extraction of wisdom teeth at a single appointment (Group A) versus two separate appointments (Group B) on patients' oral health-related quality of life (OHRQoL). The primary outcome is Oral Health Impact Profile 14 score, while secondary outcomes included postoperative pain and maximum interincisal opening.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Patients referred to the Oral and Maxillofacial Surgery Department for bilateral extraction of impacted mandibular third molars.
  • Asymptomatic, impacted mandibular third molars.
  • Impaction classified as Class I, Position A according to the Pell and Gregory classification.
  • Patients with an ASA (American Society of Anesthesiologists) Physical Status Classification of ASA 1.

排除标准

  • Local pathology associated with third molars (e.g., cysts or tumors).
  • Diagnosis of acute pericoronitis.
  • Usage of anti-inflammatory drugs or antibiotics within the last week.
  • Operations requiring osteotomy.
  • Patients with psychiatric disorders or taking drugs that may impair their mental health.
  • Patients unwilling to undergo data collection procedures.
  • Pregnant or lactating women.
  • Heavy smokers.
  • Operations lasting longer than 45 minutes for one side (from the time the first incision is made to the last suture placed).

结局指标

主要结局

Change from baseline oral health-related quality of life at 14 days

时间窗: Baseline, postoperative day 2, day 3, day 7, day 9, and day 14

The Oral Health Impact Profile-14 (OHIP-14) questionnaire is used to evaluate the participants' oral health-related quality of life. The OHIP-14 is a validated instrument that assesses the perceived impact of oral conditions on an individual's well-being across 14 items, each scored on a 5-point Likert scale. Lower scores indicate better OHRQoL.

次要结局

  • Change from baseline postoperative pain at 14 days(Postoperative 6th hour, 12th hour, day 2, day 3, day 7, day 9, and day 14)
  • Change in maximum interincisal opening(Baseline and postoperative day 7)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ferit Bayram

Assist. Prof.

Marmara University

研究点 (2)

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