Oral Myofunctional Pattern in Children With Anterior Open Bite

Not Applicable

Recruiting

• Conditions: Orofacial Myofunctional Disorders; Anterior Open Bite Malocclusion

• Registration Number: NCT07045779
• Lead Sponsor: University Ghent

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-22
• Status Verified: 2025-06
• Study First Submitted: 2025-06-23
• Study First Submitted QC: 2025-06-23
• Last Update Submitted: 2025-06-23
• Study First Posted: 2025-07-01
• Last Update Posted: 2025-07-01
• Primary Completion: 2026-05
• Study Completion: 2026-05-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

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

Exclusion Criteria

• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Dental occlusion characteristics	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	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.

Secondary Outcome Measures

Name	Time	Method
Oral health-related quality of life	From enrollment until 12 months after conclusion of treatment	OHRQoL will be assessed using the Childrens Oral Health Impact Profile (COHIP) (a higher score is indicative of a better OHRQoL).
Orofacial strength	From enrollment until 12 months after conclusion of treatment	Maximal strength and endurance of tongue and lips will be assessed using the Iowa Oral Performance Instrument (IOPI).

Trial Locations

Locations (1)

Ghent University; 🇧🇪 Ghent, Belgium