Myofunctional Therapy in Open Bite - RCT
Myofunctional
Effectiveness of Myofunctional Therapy in Children With Open Bite - a Randomized Clinical Trial
1 other identifier
interventional
80
0 countries
N/A
Brief Summary
The goal of this clinical trial is to learn if myofunctional therapy in 6-10-year-old children with infant type of swallowing and open bite is effective. Primary hypothesis: myofunctional therapy results in correction of open bite Researchers will compare a group in which myofunctional therapy is performed for 6 months to a group in which myoufunctional therapy will be delayed by 1 year. Participants will exercise according to a pre-established regimen and schedule
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2024
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 13, 2024
CompletedFirst Posted
Study publicly available on registry
August 28, 2024
CompletedStudy Start
First participant enrolled
October 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2028
August 28, 2024
August 1, 2024
3 years
August 13, 2024
August 25, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overbite
presence positive vertical (i.e. the upper teeth overlap the lower teeth) and horizontal (i.e. the upper teeth are positioned in front of the lower teeth) occlusion
12months
Secondary Outcomes (2)
Swallowing pattern
12 months
Articulation
12 months
Study Arms (2)
Myofunctional +
EXPERIMENTALA series of myofunctional exercises
Myofunctional -
ACTIVE COMPARATORNo exercises
Interventions
NO exercises; A series of myofunctional exercises performed in 10-20 sessions over 6 months is delayed by 1 year
Eligibility Criteria
You may qualify if:
- generally healthy children aged 6-10 years,
- infant swallowing type,
- open anterior occlusion (i.e. no contact between the maxillary and mandibular medial incisors),
- mixed dentition
You may not qualify if:
- finger sucking habit (or similar) occurring within the last 6 months,
- previous myofunctional therapy,
- upper airway obstruction,
- congenital craniofacial developmental disorder,
- connective tissue or muscle disease,
- macroglossia,
- ankyloglossia,
- mental retardation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Piotr Fudalejlead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 13, 2024
First Posted
August 28, 2024
Study Start
October 1, 2024
Primary Completion (Estimated)
October 1, 2027
Study Completion (Estimated)
October 1, 2028
Last Updated
August 28, 2024
Record last verified: 2024-08