Non-closure of Alveoli After Avulsion of Wisdom Teeth: a Randomized, Open, Multicenter Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 6
- 主要终点
- Visual analog scale for pain.
研究概览
简要总结
The main objective of this study is to evaluate postoperative pain (measured by visual analogue scale (VAS) on day 2 post surgery) in patients operated for avulsion of four wisdom teeth under general anesthesia and for whom the resulting alveoli were NOT sutured versus a similar group of patients undergoing standard care (suturing for lower alveoli).
详细描述
The secondary objectives of this study are to compare the following between the two study arms:
A. Pain at day 31 B. Operative time C. Edema D. Trismus E. The occurrence of complications F. Alveolar flap healing G. The impact of smoking on the occurrence of complications H. The consumption of analgesics and use of local pain remedies I. Impact on quality of life
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient was correctly informed about the implementation of the study, its objectives, constraints and patient rights
- •The patient gave his/her free and informed signed consent
- •For patients under 18 years of age, the patient's parents (or legal guardian) must have given their free and informed signed consent
- •The patient must be affiliated with or the recipient of a health insurance program
- •The patient is available for 31 days of follow-up
- •The patient is a candidate for avulsion of all 4 wisdom teeth under general anesthesia
排除标准
- •The patient is participating in another study
- •The patient has participated in another study in the last 3 months
- •The patient is in an exclusion period is determined by a previous study
- •The patient is an adult under guardianship
- •The patient is under judicial protection
- •The patient refuses to sign the consent
- •It is impossible to correctly inform the patient
- •For patients under 18 years of age, his/her parents (or legal guardian) refuse to sign the consent
- •The patient is pregnant, breastfeeding or parturient
- •The patient has a contra-indication (or an incompatible combination therapy) for a treatment in this study
- •The patient is taking antiplatelet agents
- •The patient is taking anticoagulants
- •The patient has a coagulation disorder
- •The patient suffers from immunosuppression
- •The patient's wisdom teeth are in a normal, functional, healthy position
- •Other orofacial surgical procedures are planned during the study period
- •Active pericoronitis
研究组 & 干预措施
Routine third molar extraction
Patients randomized to this arm will have all four wisdom teeth removed according to usual, standard care (i.e. with suturing of the lower alveoli).
Intervention: Suturing of lower alveoli
干预措施: Suturing of lower alveoli (Procedure)
Third molar extraction without suturing
Patients randomized to this arm will have all four wisdom teeth removed according to usual, standard care, except that the resulting alveoli will not be sutured.
Intervention: Non suturing of lower alveoli
干预措施: Non suturing of lower alveoli (Procedure)
结局指标
主要结局
Visual analog scale for pain.
时间窗: Day 2
Surgery is on day 0.
次要结局
- Visual analog scale for pain.(Day 31)
- Edema(Day 31)
- Operative time(Day 0)
- Trismus(Day 31)
- The occurrence of complications(Day 0)
- For the experimental arm: good flap healing? (ie no attachment loss at the second molar) (per tooth).(Day 31)
- The consumption of analgesics(Day 31)
- The General Oral Health Assessment Index questionnaire(Day 31)