Application of Surgical Templates in the Surgical Exposure of Impacted Canines
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Success of the open eruption technique
研究概览
简要总结
The first choice therapy in case of palatally impacted canines is their exposure and orthodontic eruption to improve facial esthetics and prevent pathologies associated with impacted teeth and Temporomandibular Joint Disorders. Current solutions in digital dentistry allow the registration of three dimensional imaging datasets such as cone beam computed tomography (CBCT) and digital impression of the dentition and soft tissues obtained via intraoral scanning using orthodontic planning software. This allows the surgeon to visualize the position of the impacted canine prior to surgery and to design and manufacture a surgical guide to aid in the localization of the impacted tooth during surgery.
The aim of this randomized clinical trial is to assess the feasibility of surgical exposure of palatally impacted upper canines with open-eruption technique using a surgical template. The secondary purpose of this study is to compare this method with the conventional free-hand surgical exposure.
Patients included in this study are randomly assigned to two study groups. In Group 1 surgical exposure for open eruption of palatally impacted canines is performed following virtual planning using a surgical template. In Group 2 surgical exposure for open-eruption of palatally impacted canines is carried out using the conventional free-hand method.
We hypothesize that guided exposure of the impacted canines will be as successful as the conventional method with shorter surgical intervention and higher associated costs.
详细描述
Objectives The aim of this randomized clinical trial is to assess the feasibility of surgical exposure of palatally impacted upper canines with open-eruption technique using a surgical template. The secondary purpose of this study is to compare this method with the conventional free-hand surgical exposure. Our null-hypothesis is that there will be no significant differences in the outcome measures between the two methods.
Materials and methods
Groups
- Group 1 (test group): Surgical exposure for open eruption of palatally impacted canines following virtual planning using a surgical template.
- Group 2 (control group): Surgical exposure for open-eruption of palatally impacted canines using the conventional free-hand method.
Simple randomization is performed to determine whether patients are included in the test or control group. 20 patients are recruited per group. During continuous recruiting, sample size calculation is to be carried out to determine the actual number of patients included in this study.
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 11 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between the age of 11-18 of the Department of Community Dentistry, Semmelweis University, who need surgical exposure and orthodontic eruption of their palatally impacted canines on one or both sides during their orthodontic treatment are included in this study.
排除标准
- •Uncontrolled systemic diseases that contraindicate orthodontic treatment or minor dental surgery,
- •Trauma in the patient's history in the vicinity of the surgical site.
- •Dental abnormalities (hyperdontia, hypodontia, etc.),
- •Congenital craniofacial disorders,
- •Permanent teeth extraction-based treatment,
- •Periodontal disease,
- •Cases in which the canine is to be brought into the position of the lateral incisor,
- •Agenesis of lateral incisors on the impaction side,
- •Documented learning disability,
- •Insufficient oral hygiene, and
- •Non-compliance during the combined orthodontic-surgical treatment.
研究组 & 干预措施
Palatally impacted canine exposure using a surgical template
干预措施: Palatally impacted canine exposure using a surgical guide (Other)
Palatally impacted canine exposure using the conventional free-hand method
干预措施: Palatally impacted canine exposure using the conventional free.hand method (Other)
结局指标
主要结局
Success of the open eruption technique
时间窗: 1 year
Measures whether the canine erupts in its correct place in the dentition following tha application of orthodontic forces.
Success of the intervention
时间窗: on the day of the surgery
Measures if an attachment could be bonded to the impacted tooth during the surgery.
次要结局
- Surplus costs of surgical planning and manufacturing the surgical guide(through study completion, an average of 1 years)
- Duration of the surgical intervention(during surgery)
- Postoperative pain(1 week)
- Intra- and postoperative complications associated with surgery(through study completion, an average of 1 years)
研究者
Marton Kivovics
senior lecturer
Semmelweis University