Evaluation of the Myobrace Appliance in Correcting Crossbite During the Mixed Dentition Stage: A Randomized, Controlled Clinical Trial
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
- 1
- 主要终点
- Change in Crossbite Correction Status
研究概览
简要总结
This randomized controlled clinical trial will evaluate the effectiveness of the Myobrace appliance in correcting anterior and posterior crossbite in children aged 6 to 10 years during the mixed dentition stage. The study will compare the clinical effects of Myobrace with those of the Frankel III appliance. The study will assess changes in occlusion, skeletal and dentoalveolar relationships, and soft tissue characteristics before and after treatment. The study will also evaluate the effectiveness of the two treatment approaches in improving crossbite correction and related orthodontic outcomes.
详细描述
Crossbite is a common malocclusion in children and may involve anterior or posterior teeth. Early management during the mixed dentition stage may help improve the occlusal relationship and reduce the potential for progression of the malocclusion.
This randomized controlled clinical trial is designed to evaluate the effectiveness of the Myobrace appliance for the correction of crossbite in children aged 6 to 10 years during the mixed dentition stage. The study will compare treatment with the Myobrace appliance with treatment using the Frankel III appliance.
Eligible children with anterior and/or posterior crossbite will be allocated to one of the treatment groups according to the study randomization protocol. Participants will receive the assigned appliance and will be followed throughout the treatment period according to the study protocol.
Treatment effectiveness will be evaluated by comparing clinical and orthodontic measurements obtained before and after treatment. The assessment will include correction of the crossbite and changes in skeletal, dentoalveolar, and soft tissue relationships. Cephalometric analysis will be used to assess relevant skeletal, dentoalveolar, and soft tissue changes.
The study will provide clinical information regarding the effectiveness of Myobrace treatment for crossbite correction during the mixed dentition stage and will allow comparison of its treatment effects with those of the Frankel III appliance.
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
- 6 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of anterior crossbite, posterior crossbite, or both.
- •Yemeni children aged 6 to 10 years.
- •Children in the mixed dentition stage.
- •No history of prior orthodontic treatment.
排除标准
- •Children with craniofacial anomalies, such as cleft lip and palate.
- •Children with severe jaw misalignment requiring complex therapy.
- •Children with complete permanent dentition.
- •Children currently undergoing orthodontic treatment
- •Children or parents/guardians unwilling to provide informed consent or participate in the study.
- •Children with predicted or observed poor compliance, including behavioral issues that may interfere with treatment or study procedures.
研究组 & 干预措施
Myobrace Group
Participants assigned to this arm will receive the Myobrace® Interceptive Class III appliance during the mixed dentition stage. Participants will be instructed to wear the appliance for approximately 1-2 hours during the day and overnight, together with daily myofunctional exercises and instructions regarding nasal breathing, tongue posture, swallowing, and lip competence. Treatment will continue until crossbite correction is achieved or for a maximum of 18 months, whichever occurs first.
干预措施: Myobrace Interceptive Class III Appliance (Device)
Frankel III Group
Participants assigned to this arm will receive the Frankel III (FR-III) functional regulator during the mixed dentition stage. The appliance will be used according to the clinical treatment protocol. Treatment will continue until crossbite correction is achieved or for a maximum of 18 months, whichever occurs first. Clinical and cephalometric assessments will be performed before and after treatment to evaluate changes in skeletal, dentoalveolar, and occlusal relationships.
干预措施: Frankel III Functional Regulator (Device)
结局指标
主要结局
Change in Crossbite Correction Status
时间窗: Baseline, and up to 18 months
Change in occlusal crossbite status from baseline to treatment completion, assessed clinically by the presence or absence of anterior and/or posterior crossbite. Complete correction is defined as establishment of a normal anterior and/or posterior buccolingual occlusal relationship according to the type of crossbite present at baseline. The change will be assessed for each participant by comparing the post-treatment crossbite status with the participant's baseline status. The changes will then be compared between the Myobrace and Frankel III groups. Baseline and at treatment completion, defined as when anterior crossbite correction is achieved or at 18 months, whichever occurs first.
次要结局
- Change in Overjet(Baseline, and up to 18 months.)
- Change in Overbite(Baseline, and up to 18 months.)
- Anterior Crossbite Correction(Baseline, and up to 18 months.)
- Posterior Crossbite Correction(Baseline, and up to 18 months.)
- Change in ANB(Baseline, and up to 18 months.)
- Change in SNA(Baseline, and up to 18 months.)
- Change in SNB(Baseline, and up to 18 months.)
- Change in Wits Appraisal(Baseline, and up to 18 months.)
- Change in SN-MP(Baseline, and up to 18 months.)
- Change in SN-OP(Baseline, and up to 18 months.)
- Change in Ar-Go-Me (Gonial Angle)(Baseline, and up to 18 months.)
- Change in Y-axis (Por-Gns)(Baseline, and up to 18 months.)
- Change in FMA(Baseline, and up to 18 months.)
- Change in IMPA(Baseline, and up to 18 months.)
- Change in FMIA(Baseline, and up to 18 months.)
- Change in S-Go Ratio(Baseline, and up to 18 months.)
- Change in UI-SN(Baseline, and up to 18 months.)
- Change in Interincisal Angle (U1/L1)(Baseline, and up to 18 months.)
- Change in U1/NA Angle(Baseline, and up to 18 months.)
- Change in U1/NA Linear Measurement(Baseline, and up to 18 months.)
- Change in L1/NB Angle(Baseline, and up to 18 months)
- Change in L1/NB Linear Measurement(Baseline, and up to 18 months.)
- Change in Nasolabial Angle (Cotg-Sn-Ls)(Baseline, and up to 18 months.)
- Change in Z Angle(Baseline, and up to 18 months.)
- Change in N-Pog-H Line (H Angle)(Baseline, and up to 18 months.)
- Change in Ls-NsPog (U lip /E line)(Baseline, and up to 18 months)
- Change in Li-NsPog (Lower Lip / E-Line)(Baseline, and up to 18 months.)
- Change in Sn-Stm : Stm-Me Ratio(Baseline, and up to 18 months.)
- Change in Gl-Sn-Pog (Facial Contour Angle)(Baseline, and up to 18 months.)
- Change in UFH (Upper Facial Height)(Baseline, and up to 18 months.)
- Change in LFH (Lower Facial Height)(Baseline, and up to 18 months.)
- Change in UFH: LFH ratio(Baseline, and up to 18 months.)
研究者
tharwa Ali Mokred AL-awadi
PhD Researcher in Clinical Dentistry (Pediatric Dentistry)
Sana'a University