Closed Versus Open Surgical Exposure of Palatally Displaced Canines (PDC); Treatment and Treatment Outcome Including Aspects of Cost-benefit and Patients´Perceptions. A Multicenter Prospective Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 6
- 主要终点
- Treatment success; the previous impacted canine is positioned in the dental arch
研究概览
简要总结
Permanent canines in the maxilla usually erupt into the mouth at 11-12 years of age. In approximately 2% of the Swedish population they fail to erupt, and are then referred to as impacted. One severe complication of impacted maxillary canines is damage (root resorption) to the roots of adjacent teeth. The root resorption may be so severe that neighboring teeth are lost. If the impaction is detected early (at 9-10 years of age), the recommended treatment is to extract the deciduous canine, to help the permanent canine to resolve its unfavorable position. If there is no improvement of the position of the canine 1 year after the extraction, surgical and orthodontic treatment is indicated. Surgical exposure is followed by orthodontic treatment with fixed appliance for 2 to 3 years to bring the canine into correct position.
Two different main principles of surgical exposure in palatally impacted maxillary permanent canines are the so called closed versus open surgical techniques.
Closed technique involves surgically uncovering of the canine with a mucoperiosteal flap dissected off the bone. The bone covering the canine is being removed and an attachment with a chain is bonded to the tooth. The flap is repositioned and sutured back with the chain above the mucosa. Shortly after the surgery, orthodontic force is applied via the chain. The canine is orthodontically moved beneath the palatal mucosa by forced eruption.
Open technique involves surgically uncovering of the canine, removing a window of tissue around it and placing pack to cover the exposed area. Then the treatment approaches vary depending on whether the attachment with a chain is bonded to the exposed tooth at surgery or if spontaneous eruption of the palatally impacted canine is expected postsurgically. In both alternatives orthodontic force is applied via the chain and the canine is orthodontically moved above the mucosa. These two techniques of surgical exposure of palatally impacted canines seem to be the two routinely used in Sweden.
The purposes of this study are to examine, describe and compare the treatment outcomes in regard to success and duration of treatment, complications, side effects, cost-benefit aspects and patients´ perceptions in closed versus open surgical exposure techniques, in cases with palatally impacted canines.
The objective is to test the null hypothesis that there are no differences in the above outcomes between open or closed surgical exposure of palatally impacted canines.
详细描述
Methods of exposing canines are today left to the personal choice of the surgeon and orthodontist. According to an unpublished survey among orthodontists in Sweden 2012, 80% of them use the closed technique only, 9% use the open technique only and 11% use both techniques. This result may be compared to a similar survey performed in the UK, where 29% selected a closed surgical technique only, 40% selected an open surgical technique only and the remainder chose combinations of techniques.
Mentioned reasons for preference of the closed technique are less pain and need for analgesics and faster recovery of pain, postsurgically. Some orthodontists that prefer the open exposure technique have experienced more patient related pain or discomfort in the closed exposure technique, in association with activation in orthodontically forced eruption, because the palatally impacted canine is moved beyond the mucoperiosteal flap. There are no previous studies in this aspect, though.
Factors as operation time, total treatment time and periodontal health measurements after surgical exposure and orthodontic forced eruption of impacted canines, have shown heterogeneity in different retrospective studies.
The management of the palatally impacted canines is a multidisciplinary, time consuming treatment, contributing to relatively high society costs, why this study is taking place, trying to clarify some issues in the choice of method and treatment.
Subjects Patients with diagnosis of uni- or bilateral palatally impacted canine/-s planned for surgical exposure are included consecutively at three orthodontic centers of the Public Dental Health Service in the towns of Orebro, Eskilstuna and Jönköping, Sweden.
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
- 8 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with diagnosis of uni- or bilateral palatally impacted canine/-s planned for surgical exposure at start of treatment of the impacted canines. In the bilateral impaction cases, the impacted canine in the more severe position according to the criteria (in Zone 2-4) proposed by Ericson and Kurol is included in the trial.
- •Dental development stage: maxillary DS2M1 and DS3M2 according to Björk
- •Pretreatment mesial position of the impacted canine in Zone 2-4, according to the criteria proposed by Ericson and Kurol, documented in panoramic radiographs.
排除标准
- •Diseases affecting the somatic and/or craniofacial growth
- •Diseases not compatible with anaesthesia or surgery
- •Known neuropsychiatric diagnosis or documented learning disability
- •Problem to understand Swedish (patient and parent). Interpreter needed
- •Patients older than 16 years of age at the year of start of treatment
- •Ongoing orthodontic treatment
- •Patients with agenesis of the lateral incisor in the impacted side
- •Pretreatment mesial position of the impacted canine in Zone 5, according to the criteria proposed by Ericson and Kurol, documented in panoramic radiographs
- •Pretreatment vertical position of the impacted canine above the full length root of the central incisor on the same side, according to Fleming, PS. et al.
结局指标
主要结局
Treatment success; the previous impacted canine is positioned in the dental arch
时间窗: Within 3 years after surgery
"Positioned in the dental arch"; here meaning that the previous impacted canine has been treated with fixed orthodontic braces and is inligated in .016x.022 nickel titanium/ standard steel arch-wire in a .018- appliance system and .019x.025 nickel-titanium/ standard steel arch-wire in a .022- appliance system.
次要结局
- Duration from surgery until the previous impacted canine has erupted into the mouth(Within 1,5 year from surgery)
研究者
Margitha Björksved
DDS, MSc
Örebro County Council