Oral Myofunctional Pattern in Children With Anterior Open Bite

Официальное название

The OMBIT Study: Oral Myofunctional Pattern in Children With Anterior Open Bite

Обзор

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.

Вмешательства

• Поведенческое Orofacial myofunctional therapy - traditional
  Behavioral interventions, like orofacial myofunctional therapy (OMT), target brain reorganization and plasticity by establishing new motor patterns or re-establishing old ones. The aim of OMT is to correct pathological function and resting positions based on the equilibrium theory. A service model that is often used in OMT is the model provided by Garliner, which includes a 10 week OMT program with a frequency of one session of 45 minutes per week together with home practice. Treatment sessions
• Поведенческое Orofacial myofunctional therapy - reduced
  Behavioral interventions, like orofacial myofunctional therapy (OMT), target brain reorganization and plasticity by establishing new motor patterns or re-establishing old ones. The aim of OMT is to correct pathological function and resting positions based on the equilibrium theory. A service model that is often used in OMT is the model provided by Garliner, which includes a 10 week OMT program with a frequency of one session of 45 minutes per week together with home practice. Treatment sessions
• Поведенческое Vocal warm up
  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. Exercises that will be included are: open mouth approach, glottal fry, producing ascending and descending tones and the hand-over-mouth technique. These exercises aim to improve the dynamics of the extrinsic and intrinsic laryngeal muscles and therefore are expected not to interfere with the content of the OMT progr

Первичные конечные точки

• Dental occlusion characteristics [Срок оценки: From enrollment until 12 months after conclusion of treatment]
• Orofacial myofunctional status [Срок оценки: From enrollment until 12 months after conclusion of treatment]

Вторичные конечные точки (2)

• Oral health-related quality of life [Срок оценки: From enrollment until 12 months after conclusion of treatment]
• Orofacial strength [Срок оценки: From enrollment until 12 months after conclusion of treatment]

Критерии участия

Критерии включения

• Presence of anterior open bite (AOB)
• Early or intermediate mixed dentition phase

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Бельгия · 1 центр

• Ghent University — Ghent

Идентификаторы

NCT: NCT07045779 · ONZ-2022-0135

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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