Treatment of Palatally Displaced Maxillary Canines - a Controlled Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 88
- 试验地点
- 4
- 主要终点
- Success of treatment
研究概览
简要总结
Permanent maxillary canines are the second teeth that most commonly assume ectopic positions after the third molars. They are diagnosed as impacted and have an incidence of 1 % to 3%
In their ectopic path of eruption, they can cause damage (resorption) of the adjacent roots, a severe complication that may lead to the loss of anterior teeth. When cone-beam computed tomography (CT) scanning is used for diagnose, root resorption is detected in two-thirds of the lateral incisors adjacent to impacted maxillary canines before treatment.
The treatment of this condition comprises two stages: a surgical intervention to uncover the canine crown followed by orthodontic treatment to move the canine into correct position. The surgical intervention commonly involves two different techniques: the open and the closed technique.
The open technique procedure involves removing the bone and mucosa covering the crown of the canine. The exposed crown is left uncovered and a pack is placed over the area to avoid overgrowth of tissue. When enough spontaneous eruption of the canine has occurred, an orthodontic attachment is bonded to the crown and the tooth is moved above the mucosa with orthodontic appliances into the correct position.
The closed technique procedure involves bonding an orthodontic attachment to the crown with a chain after exposing the canine during the surgery. The palatal flap is sutured back covering the exposed crown and the chain is left through the palatal mucosa free in the oral cavity. Shortly after, the canine is forced to erupt through the palatal mucosa and moved into the correct position with orthodontic appliances.
The purpose of this prospective randomized clinical trial is to compare outcome variables between the Open and Closed surgical exposure techniques regarding the success of treatment, patient's perceptions of pain and discomfort experienced and analgesic consumption, treatment time, and complications. The null hypothesis is that similar outcomes occur when the surgical exposure of palatally impacted canines is performed by using the open or the closed surgical technique.
详细描述
Consecutive patients planned for surgical exposure of uni- or bilateral palatally impacted canines of two centers, are invited to participate in the Trial. The centers are the University Orthodontic Departments of Oslo, Norway, and Jonkoping, Sweden.
Potential participant patients and their parents are given verbal and written information about the Trial and Informed Consent is obtained.
Participants are randomly allocated to one of two interventions by use of Permuted Block Randomization in order to maintain equal allocations across treatment groups. Allocation concealment is held by one individual in each center that is not involved in the study. No stratification is made for age or gender in the two groups.
If the maxillary deciduous canine is present at the time of the surgery, the tooth is removed together with the exposure of the impacted canine.
Before entering the surgery room, participants answer a first questionnaire on whether they are experiencing pain or discomfort (measured in VAS-scales) in the area of the impacted canine and whether they have taken analgesics. The questionnaire is filled in and delivered back before entering the surgery room. After the surgical exposure, verbal and written information and recommendations on chlorhexidine mouth rinse and analgesic consumption are given. A second questionnaire is then handed out for participants to self-report the pain-discomfort they experienced during surgery, and are experiencing in the evening the same day and the following seven days together with the analgesic consumption. The second questionnaire is delivered back to the clinic at the post-surgical control.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Consecutive patients diagnosed with palatally impacted canine with a sagittal position in Zone 2-4 as documented on panoramic radiographs according to the criteria proposed by Ericson and Kurol,1988, planned to start treatment with surgical exposure of the impacted canine.
- •Patients with uni- or bilateral impacted canines are included. In bilateral impaction cases, the more severely positioned impacted canine according to the Zone (Zone 2 - 4) is included in the trial.
- •No restriction of presenting malocclusion
- •Dental developmental stage: Maxillary DS2M1 and DS3M2 according to Bjork.
- •Age not older than 16 years at surgery
排除标准
- •Agenesis of lateral incisors on the impaction side
- •Peg-shaped lateral incisors on the impaction side
- •Previous orthodontic treatment
- •Subjects with craniofacial deformity/ syndromes
- •Documented learning disability
- •Communication problems related to the language when an interpreter is needed
- •Sagittal position of the impacted canine in Zone 5, according to Ericson and Kurol, documented on panoramic radiographs.
结局指标
主要结局
Success of treatment
时间窗: Within 3 years from surgery
The canine is aligned in the dental arch. "Aligned in the dental arch" meaning the canine being ligated to a 0.016 X .0.22 nickel- titanium/ standard steel in a 0.018-appliance system or to a 0.019 X 0.025 nickel-titanium/ standard steel arch-wire in a 0.022- appliance system
Patient's perceptions of pain-discomfort experience and analgesic consumption
时间窗: Within 3 years from surgery
Perceptions of pain-discomfort experienced and analgesic consumption are self reported on a 100 mm visual analogue scale (VAS) and questionnaires in the first evening and the following 7 evenings, after surgery, after suture and pack removal and after every second/ third orthodontic activation.
次要结局
- Canine eruption time(Within 1,5 years from surgery)
研究者
Lucete Fernandes faerovig
Principal investigator
University of Oslo