The Clinical Effect of Autogenous Dentin Graft in Mandibular Third Molar Surgery
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Rate of self-reported pain
研究概览
简要总结
The study aimed to investigate clinical effect of autogenous dentin graft on patients following mandibular wisdom tooth extraction. The primary outcomes are pain, swelling, trismus and soft tissue healing index within one week after surgery. The investigators also measured periodontal healing of distal aspect of the adjacent second molar up to 2 year after the surgery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Over 18 years old
- •Symmetry mandibular third molars
- •Symmetry maxillary third molars with no caries or periodontal disease
- •Mandibular second molars are available
排除标准
- •Systematic health has contraindication for surgery
- •Pregnant or breastfeeding women
- •Allergy with Lidocaine
- •Abnormal signs surrounding mandibular third molars
结局指标
主要结局
Rate of self-reported pain
时间窗: 3 days, 7 days
Pain is measured by self-reported Likert scale from 0 to 5. Higher score indicated more painful situation. Result is reported by the mean score.
Self-reported swelling
时间窗: 3 days, 7 days
Patients reported their perception about swelling levels. There are 6 levels of this scale, score from 0 to 5. Higher score means more swelling.
Aveolar height
时间窗: 7 days, 2 months, 6 months, 2 years
Aveolar height is measured as the distance from cementoenamel joint on distal surface of second molar to the aveolar ridge. The landmark points are defined on periapical film. The aveolar height is measured at 7 days, 3 months, 6 months and 2 years after the surgery.
Swelling measured by facial dimension
时间窗: 3 days, 7 days
Difference of distances of facial landmark points between post-and pre-operative wisdom tooth surgery. Two distances (AB and CD) from 4 landmark points are used for measurement: A - lateral commissure of the eye, B - gonion, C - tragus, and D - lateral commissure of the lips.
Trismus
时间窗: 3 days, 7 days
Trismus is measured by difference of maximal mouth opening between post-and pre-operative wisdom tooth surgery. Maximal mouth opening is mueasured by distance of mesial incisal edge of maxillary and mandibular central incisor.
Soft tissue healing score
时间窗: 3 days, 7 days, 30 days
The soft tissue healing score is evaluated according to Hamzami (2018). It includes 8 sub-items. Each item is recorded as 0 or 1 (score). Then, total score of the first 30 days (3 evaluation time) is used to classify wound healing level (good, acceptable, and bad).
次要结局
未报告次要终点
研究者
Son Hoang Le
Lecturer
University of Medicine and Pharmacy at Ho Chi Minh City