Comparison of Two Flaps in Surgical Removal of Impacted Lower Third Molar;a Randomized Comparative Double Blind Study
试验速览
- 阶段
- 不适用
- 入组人数
- 70
- 主要终点
- operative time taken for the surgical removal of impacted lower third molar
研究概览
简要总结
Project summary
The surgical removal of mandibular third molar is one of the most common procedures done in oral and maxillofacial surgery. Patients often experience pain, swelling, trismus, dehiscence, alveolar osteitis, infection, nerve injury and periodontal tissue damage after third molar surgery. Flap design is an important step in third molar surgery.The aim of this study is to compare the triangular and envelope flap designs in lower third molar surgery in terms of postoperative sequelae including pain ,trismus,swelling,incidence of dry socket and also operative time taken.The study also aims to find out does the level of impacted mandibular third molar and number of roots has effect on postoperative outcomes in surgical removal of mandibular third molar.The study design used will be a double-blind randomized clinical study. Patients who fit the inclusion criteria will be included as research subjects.Sample will be divided into two groups randomly. In one group the envelope flap will be raised during surgical removal of the lower third molar while in the other triangular flap will be used.
Investigators will also divide the third molars into level 1,level 2,level 3 based on the relationship between the tip of mesial cusp of impacted third molar and the distal surface of crown of adjacent second molar based on orthopantomograph findings.Level 1 will be when the tip of mesial cusp of third molar is within the occlusal third of crown of second molar,level 2 will be when the tip of mesial cusp of third molar is within the middle third of crown of second molar, level 3 will be when the tip of mesial cusp of third molar is within and below the cervical third of crown of second molar.
Another subgroup will be based on the number of roots of the impacted third molar where investigators will divide the third molar into single rooted and multirooted based on orthopantomograph findings.
Investigators will also divide the sample based on gender and age group as below 30 years and above 30 years.
The primary outcomes to be measured are pain and operative time while secondary outcomes are swelling ,trismus and incidence of dry socket.Outcome assessment will be done by another clinician than surgeon using scientific tools and techniques as mentioned.
Surgical procedures and outcomes measurement will be done by separate clinicians to ensure masking.
详细描述
Andreasen et al (1997) defines impaction as a cessation of the eruption of a tooth caused by a clinically or radiographically detectable physical barrier in the eruption path or by an ectopic position of the tooth. The prevalence of third molar impaction ranges from 16.7% to 68.6%. Common pathologies associated with third molars are pericoronitis, caries of impacted teeth or adjacent tooth, second molar tooth resorption, periodontal bone loss of adjacent tooth and odontogenic cysts. The surgical removal of mandibular third molar is one of the most common procedures done in oral and maxillofacial surgery. Flap design is an important step in third molar surgery.Commonly used flap in surgical removal of third molar are envelope flap and triangular flap with modifications.
A number of classifications have been developed for impacted third molars.The most widely used are;
- Angulation (Winter, 1926) of the impacted tooth ; Vertical, Mesioangular, Horizontal, Distoangular
- Relationship of the impacted tooth to the anterior border of the ramus (Pell and Gregory, 1942); Class I: Sufficient space available anterior to the anterior border of ramus for the third molar to erupt.
Class II: Space available is less than the mesio distal width of the crown of the third molar Class III: All or most of the third molar is located within the ramus. 3. Depth of impaction (Pell and Gregory Classification based on relationship to occlusal plane); Position A: The highest portion of the tooth (occlusal plane) is on a level with or above the occlusal line.
Position B: The highest portion of the tooth is below the occlusal line but above the cervical line of the second molar.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18-50 years
- •No systemic illness and not taking any regular medications
- •No signs of local inflammation
- •Mesioangular and vertically impacted lower third molar
- •Not under antibiotics for at least 3 days before surgery
排除标准
- •With known systemic illness
- •Those taking regular medications
- •Presenting with pain and swelling at the time of surgery
- •Impactions other than mesioangular and vertical impactions of lower third molar
- •Under antibiotics within 3 days of surgical procedure
- •Those having habit of cigarette smoking and females taking oral contraceptives
结局指标
主要结局
operative time taken for the surgical removal of impacted lower third molar
时间窗: immediately after surgery
The operative time taken will be recorded from the point of incision to the point of last suturing in terms of minutes.
postoperative pain Post operative pain which will be measured based on the questionnaires on defined post operative days
时间窗: 7th postoperative day
The postoperative pain will be measured by the visual analogue pain scale grading from 0 to 10 where score of 0 means no pain and 10 means maximum pain that can be felt by patient.
次要结局
- postoperative swelling(7th postoperative day)
- post operative trismus(7th postoperative day)
- dry socket(7th postoperative day)
研究者
Ashutosh Kumar Singh
Lecturer of department Oral And Maxillofacial Surgery
College of Medical Sciences Teaching Hospital. Nepal