Anchorage Reinforcement in Bimaxillary Proclination Cases - a 3-arm Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- molar movement
研究概览
简要总结
Bimaxillary protrusion are common in Malaysia due to the prevalence in the two biggest races (Malay and Chinese). However, evidence for treatment methods and outcomes for bimaxillary protrusion patients are scarce. The need for high anchorage in bimaxillary protrusion cases also makes them perfect candidates for a study on the effectiveness of different anchorage methods commonly used in treatment of bimaxillary protrusion cases. The soft tissue outcomes from the use of these different methods are also our area of interest. Hence, the investigators aim is to prove that molar block anchorage similarly effective and has the same outcome as using other conventional auxiliary anchorage such as TPA and Nance button in treating patients with bimaxillary protrusion.
详细描述
Bimaxillary proclination is common in Malaysia especially among Malay, Chinese and possibly the Malaysian Aborigines. Treatment commonly constitutes extraction of upper and lower first permanent premolars with maximum anchorage requirement. Various anchorage device exists, but conventional devices such as Nance button, transpalatal arch and molar blocks are still commonly used to good effect in treatment of bimaxillary proclination. A comparison of these commonly used conventional anchorage devices (molar block, transpalatal arch, Nance button), especially in treating bimaxillary proclination cases, surprisingly has not been done.
Soft tissue changes also occur in bimaxillary proclination. However, changes in the soft tissue profile using these conventional anchorage devices do not exist, as evidence shows that anchorage devices can affect soft tissue outcomes
Hence, the investigators aim to investigate compare the effectiveness and soft tissue changes of using just molar blocks, molar blocks with transpalatal arch and molar blocks with Nance button.
This study will be done as a 3-arm parallel randomised controlled trial. The allocation ration is set at 1:1:1. This study will adhere to the PICO and CONSORT guidelines, and will be registered with the clinical.org website.
Sample size calculation was conducted using G Power 3.9.1.4. The standard deviation of the movement of maxillary permanent first molar was estimated at 2.2 mm. The mean difference of 1.00 mm was considered the smallest important difference to be detected, which was also used as the effect size. In order to detect the difference of 1.00 mm with a power of 0.80 (80%) and an alpha of 0.05, accounting for a 20% dropout, the total sample size required is 15, which will be randomised into 3 groups (5 Nance group, 5 TPA group and 5 molar block group).
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with:
- •a need to correct bimaxillary proclination
- •age of 16 years old and above
- •a need for extraction of the permanent first premolars
- •mild space requirement (less than 4mm), no crowding or spaced dentition
- •good oral hygiene
排除标准
- •Patient with
- •hypodontia
- •history of orthodontic treatment or extractions (except third molars)
- •congenital oral-maxillofacial deformities such as cleft lip and palate
- •syndromic diseases
- •orthognathic treatment need
- •poor dental health precluding orthodontic treatment
研究组 & 干预措施
molar block
No additional anchorage reinforcements besides the banding first and second molar with and tying them together at the buccal tubes (also known as molar block)
TPA group
Bands are selected and an alginate impression taken over the bands. The impression will be sent to the lab for the construction of a transpalatal archwire on a 1.0 mm stainless steel wire connecting the upper permanent first molar, with a U loop pointing posteriorly, soldered to the palatal side of the molar bands. The appliance will be fitted a week later. Molar bands will be fitted to the permanent second molar on the same appointment, with a ligature wire tying the first molar band together at the buccal tubes. The resulting anchorage reinforcement is a molar block with a transpalatal archwire.
干预措施: transpalatal arch group (Device)
Nance button group
Bands are selected and an alginate impression taken over the bands. Bands are replaced on the tooth and an alginate impression taken over the bands. The impression will be sent to the lab for the construction of a transpalatal archwire on a 1.0 mm stainless steel wire connecting the upper permanent first molar, with a Nance button incorporated in the middle of the wire, soldered to the palatal side of the molar bands. The appliance will be fitted a week later. Molar bands will be fitted to the permanent second molar on the same appointment, with a ligature wire tying the first molar band together at the buccal tubes. The resulting anchorage reinforcement is a molar block with a Nance button
干预措施: Nance button (Device)
结局指标
主要结局
molar movement
时间窗: 24 months
Three plane movement of the maxillary permanent first molar in terms of anchorage loss (in mm)
Soft tissue cephalometric changes (degrees)
时间窗: 24 months
E line, labiomental sulcus depth, upper lip length, lip protuberance
Soft tissue cephalometric changes (angle)
时间窗: 24 months
Nasolabial angle, H angle and facial convexity angle
次要结局
- Number of treatment visits (days)(24 months)
- Hard tissue cephalometric changes (degrees)(24 months)
- Duration of treatment visits (minutes)(24 months)
研究者
Dr. Kumeran Mohan
Dr
University of Malaya