The OMBIT Study: Oral Myofunctional Pattern in Children With Anterior Open Bite
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 33
- 试验地点
- 3
- 主要终点
- Dental occlusion characteristics
研究概览
简要总结
Oral myofunctional disorders (OMD) are a key, internationally acknowledged environmental factor causing dental and skeletal malocclusion. For the past 15 years, research regarding the efficacy of orofacial myofunctional therapy (OMT) to reduce OMD and to contribute to the treatment of malocclusions has been significantly increased. Despite the growing interest, high-quality evidence is still lacking because studies show a lack of standardized assessment techniques, outcome measures, and inclusion criteria, important methodological limitations such as small sample sizes, a variety of content and service delivery models and a lack of long-term follow-up.
The goal of this clinical trial is to evaluate the effects of structured OMT on anterior open bite (AOB) in children in early or intermediate mixed dentition. The main questions it aims to answer are:
- Does a structured OMT program affect orofacial myofunctional patterns, dental occlusion, and oral health-related quality of life (OHRQoL) in children with AOB?
- Are there differences in treatment outcomes between children receiving a traditional OMT program, a reduced OMT program, and a sham treatment?
Participants will undergo baseline and follow-up assessments of dental occlusion, orofacial myofunctional patterns, and OHRQoL. They will follow a structured OMT protocol tailored to their assigned group and participate in weekly therapy sessions over a defined intervention period.
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 (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Presence of anterior open bite (AOB)
- •Early or intermediate mixed dentition phase
排除标准
- •History of or active engagement in orofacial myofunctional therapy (OMT)
- •History of or active engagement in orthodontic therapy
- •Congenital abnormalities, syndromes, or surgical needs affecting the oral and maxillofacial region
- •Disorders affecting motor or cognitive development
- •Current or recent (< 3 months) non-nutritive sucking habits
研究组 & 干预措施
Traditional OMT
Participants who are randomly assigned to this arm, will receive traditional orofacial myofunctional therapy (OMT), consisting of interventions targeting orofacial strength, orofacial differentiation, breathing pattern, orofacial resting postures, and swallowing pattern.
干预措施: Orofacial myofunctional therapy - traditional (Behavioral)
Reduced OMT
Participants who are randomly assigned to this arm, will receive reduced orofacial myofunctional therapy (OMT), consisting of interventions targeting orofacial differentiation, breathing pattern, and orofacial resting postures.
干预措施: Orofacial myofunctional therapy - reduced (Behavioral)
Sham treatment
Participants who are randomly assigned to this arm, will receive a sham treatment. This active control intervention will not include any of the exercises included in the experimental treatment arms. The sham treatment program will include exercises from an evidence-based vocal warm up program, with exclusion of the exercises that include active involvement of the tongue or lips. Furthermore, exercises regarding body posture (no focus on articulators), relaxation and voice onset will be included. This sham treatment program will be provided by the same speech-language pathologist with comparable motivation techniques as those applied in the real OMT programs. Patients and parents will initially not be informed about the actual purpose of this sham treatment. A debriefing will take place after the follow-up phase.
干预措施: Vocal warm up (Behavioral)
结局指标
主要结局
Dental occlusion characteristics
时间窗: From enrollment until 12 months after conclusion of treatment
Measurement of dental occlusion characteristics (overbite, overjet, palatal surface area, palatal volume) will be based on 3D digital intraoral scans. The chief among which, anterior open bite, will be measured by vertical gap measurement (mm), i.e. the vertical distance between the incisal edge of the maxillary and mandibular central incisors when in occlusion.
Orofacial myofunctional status
时间窗: From enrollment until 12 months after conclusion of treatment
Orofacial myofunctional status will be evaluated using the Orofacial Myofunctional Evaluation with Scores (OMES) protocol, a validated measure quantifying orofacial myofunctional behavior (with a lower score indicative of a more impaired orofacial function). Additionally, submandibular ultrasonography will be used to verify tongue posture at rest and swallowing pattern.
Dental occlusion characteristics
时间窗: From enrollment until 12 months after conclusion of treatment
Measurement of dental occlusion characteristics (overbite, overjet, palatal surface area, palatal volume) will be based on 3D digital intraoral scans. The chief among which, anterior open bite, will be measured by vertical gap measurement (mm), i.e. the vertical distance between the incisal edge of the maxillary and mandibular central incisors when in occlusion.
Orofacial myofunctional status
时间窗: From enrollment until 12 months after conclusion of treatment
Orofacial myofunctional status will be evaluated using the Orofacial Myofunctional Evaluation with Scores (OMES) protocol, a validated measure quantifying orofacial myofunctional behavior (with a lower score indicative of a more impaired orofacial function). Additionally, submandibular ultrasonography will be used to verify tongue posture at rest and swallowing pattern.
次要结局
- Oral health-related quality of life(From enrollment until 12 months after conclusion of treatment)
- Orofacial strength(From enrollment until 12 months after conclusion of treatment)
- Oral health-related quality of life(From enrollment until 12 months after conclusion of treatment)
- Orofacial strength(From enrollment until 12 months after conclusion of treatment)