Oral Myofunctional Pattern in Children With Anterior Open Bite
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age6-12
SponsorUniversity Ghent
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Presence of anterior open bite (AOB)
Early or intermediate mixed dentition phase
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Orofacial myofunctional therapy - traditional
BehavioralBehavioral 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 will be used to introduce and practice new exercises, to monitor home practice and motivation of the patients. Additionally, the participant will be instructed to perform the same exercises from the treatment session at home daily. This intervention will consist of (1) creating awareness, (2) establishing nasal breathing, (3) labial seal and lip closure exercises, (4) tongue posture exercises, (5) lip and tongue strengthening, (6) practicing a physiological swallowing act.
Orofacial myofunctional therapy - reduced
BehavioralBehavioral 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 will be used to introduce and practice new exercises, to monitor home practice and motivation of the patients. Additionally, the participant will be instructed to perform the same exercises from the treatment session at home daily. This intervention will consist of (1) creating awareness, (2) establishing nasal breathing, (3) labial seal and lip closure exercises, (4) tongue posture exercises.
Vocal warm up
BehavioralThe 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 program. 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.
Treatment groups
33 Participants
are divided into 3 treatment groupsGroup A: Traditional OMTExperimental treatment 1 intervention
Group B: Reduced OMTExperimental treatment 1 intervention
Group C: Sham treatmentSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
Dental occlusion characteristics
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.
Time frame
From enrollment until 12 months after conclusion of treatment2
Orofacial myofunctional status
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.
Time frame
From enrollment until 12 months after conclusion of treatmentSecondary outcomes
1
Oral health-related quality of life
OHRQoL will be assessed using the Childrens Oral Health Impact Profile (COHIP) (a higher score is indicative of a better OHRQoL).
Time frame
From enrollment until 12 months after conclusion of treatment2
Orofacial strength
Maximal strength and endurance of tongue and lips will be assessed using the Iowa Oral Performance Instrument (IOPI).
Time frame
From enrollment until 12 months after conclusion of treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
University Ghent
Lead sponsor
Research Foundation Flanders
Collaborator
Source ClinicalTrials.gov