Evaluation of a Novel Lip Bumper With Integrated Distal Shoe Appliance in Preventing Second Molar Impaction in Children With Anterior Deep Bite
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 40
- 主要终点
- Radiographic Assessment of Second Molar Eruption Angle and Position
研究概览
简要总结
The goal of this clinical trial is to evaluate the effectiveness of a novel lip bumper with an integrated distal shoe in preventing second molar impaction in children aged 8-10 years with anterior open bite during the mixed dentition stage.
The main questions it aims to answer are:
- Does the integrated distal shoe significantly reduce the risk of second molar impaction compared to conventional lip bumpers?
- Does the appliance improve anterior open bite correction and influence lower incisor inclination?
Researchers will compare Group I (lip bumper with distal shoe) to Group II (conventional lip bumper) to see if the modified appliance prevents mesial drift of first molars and improves eruption outcomes of second molars.
Participants will:
- Undergo initial records including panoramic and cephalometric radiographs, study models, and intraoral photos
- Be fitted with one of the two appliances and followed up every 6 weeks over a 12-month period
- Receive radiographic and clinical evaluation of second molar eruption
- Complete assessments related to overbite changes, incisor inclination, comfort, and compliance This trial seeks to inform early orthodontic protocols and may offer a dual-function solution for both molar guidance and open bite correction.
详细描述
This clinical research study is focused on improving early orthodontic care for children who have an anterior deep bite-a condition where the upper teeth excessively overlap the lower front teeth-and are at risk of second molar impaction, a complication where the posterior teeth do not emerge properly. Left untreated, these issues can lead to long-term dental problems including poor bite alignment, crowding, or the need for surgical intervention.
Orthodontists often use a device called a lip bumper to reduce pressure from the lips on the lower front teeth, making room for crowded teeth and promoting healthy jaw development. However, a well-known downside of using a lip bumper-especially in young children-is that it can cause the first molars to drift forward. This forward movement can block the path for the second molars, increasing the risk that they will not erupt normally.
This study introduces a novel orthodontic appliance that aims to solve both problems at once. The new device combines the benefits of a traditional lip bumper with a "distal shoe"-a small guiding component that helps maintain proper space for the second molars to erupt. By doing so, it seeks not only to correct deep bite problems but also to prevent the common and serious issue of molar impaction.
The study will involve children between the ages of 8 and 10, a key stage of dental development. Participants will receive either the new dual-purpose device or a standard lip bumper and will be monitored over the course of a year. Throughout this period, researchers will examine how the teeth are moving, whether the posterior molars are erupting properly, and how well the deep bite is improving.
In addition to clinical evaluations, the study will gather feedback from children and their parents about comfort, ease of use, and any issues related to the appliance. Understanding patient experience is a vital part of assessing whether this new approach can be widely recommended in pediatric dental care.
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 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 8 and 11 years
- •In mixed dentition stage (presence of permanent first molars and incisors; unerupted second molars)
- •Presence of an anterior deep bite of ≥ 2 mm (measured vertically between upper and lower incisors)
- •Class I or mild Class II malocclusion
- •Good general health with no systemic conditions that may affect dental development or treatment
- •Written informed consent obtained from the parent or legal guardian and assent from the child
排除标准
- •History of previous orthodontic treatment
- •Presence of craniofacial anomalies (e.g., cleft lip/palate) or syndromic conditions
- •Diagnosis of systemic diseases that affect bone metabolism or craniofacial growth (e.g., juvenile rheumatoid arthritis, osteogenesis imperfecta)
- •Evidence of poor oral hygiene or active caries requiring urgent dental care
- •Use of any medication known to affect dental development (e.g., long-term corticosteroids, antiepileptics)
- •Behavioral or developmental disorders that would preclude cooperation with appliance wear or study procedures
结局指标
主要结局
Radiographic Assessment of Second Molar Eruption Angle and Position
时间窗: At baseline and after 12 months of appliance use
Radiographic Eruption Angle Measurement Scale (in degrees) Objectives: To evaluate the effect of the appliance on the eruption trajectory and final position of the second permanent molars, using radiographic measurements to detect impaction or favorable eruption patterns. * Measurement Method: Panoramic radiograph using digital angle analysis tools to measure the angle between the long axis of the second molar and a stable reference line (e.g., occlusal plane or mandibular base). * Scale Range: * Minimum value: 0° (perfect vertical eruption) * Maximum value: \~90° (severely impacted or horizontal position) * Interpretation: * Lower scores (closer to 0°) indicate a more favorable eruption position and vertical alignment. * Higher scores (closer to 90°) indicate a worse outcome, suggesting impaction or abnormal angulation. Angular and positional changes of the mandibular second permanent molars (in degrees or millimeters) as observed on standardized panoramic radiographs
次要结局
- Change in Overbite (in mm)(Baseline and 12 months)
- Lower Incisor Inclination (IMPA - Incisor Mandibular Plane Angle) in degrees(Baseline and 12 months)
- Visual Analog Scale for Orthodontic Comfort and Tolerance (0-10 scale) Patient-Reported Comfort and Appliance Tolerance(1 week, 6 weeks, 3 months, and 12 months)
- Orthodontic Appliance Compliance Assessment Scale (0-5 scale)(at each follow-up visit (every 6 weeks))
- Soft Tissue Reaction Severity Scale (0-3 score per site)(At each 6-week follow-up visit)
研究者
Sally Abd-ElMeniem ElHaddad
Assist. Prof.
Dar Al Uloom University