Myofunctional Therapy in Open Bite - RCT | NCT06574490

Studies
Myofunctional Therapy in Open Bite - RCT

NCT06574490

Sponsor

Piotr Fudalej

Status

Not yet recruiting

Last Update Posted

Aug 28, 2024Actual

Enrollment

80Estimated

Phase

Not Applicable

Conditions

Open Bite

Interventions

Myofunctional therapy (+)
Myofunctional therapy (-)

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2024

Overall Recruitment Status or Expanded Access Status

Not yet recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Oct 2024Estimated

Primary Completion Date

Oct 2027Estimated

Completion Date

Oct 2028Estimated

First Submitted Date

Aug 13, 2024

First Submission Date that Met QC Criteria

Aug 25, 2024

First Posted Date

Aug 28, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 25, 2024

Last Update Posted Date

Aug 28, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

80Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Myofunctional +	Experimental	A series of myofunctional exercises	Procedure: Myofunctional therapy (+)
Myofunctional -	Active Comparator	No exercises	Procedure: Myofunctional therapy (-)

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Myofunctional therapy (+)	Procedure	A series of myofunctional exercises performed in 10-20 sessions over 6 months	Myofunctional +

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Swallowing pattern	swallowing pattern (infant, adult or mixed)	12 months
Articulation	articulation of l,n,d,t,s sounds.	12 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

10 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D024343	Open Bite
D009043	Motor Activity

Ancestor Terms

ID	Term
D008310	Malocclusion
D014076	Tooth Diseases
D009057	Stomatognathic Diseases
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D020247	Myofunctional Therapy

Ancestor Terms

ID	Term
D012049	Rehabilitation of Speech and Language Disorders
D012046	Rehabilitation
D000359	Aftercare
D003266	Continuity of Patient Care

Browse Leaves

Not provided

Browse Branches

Not provided