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Behavioural Intervention

Orthodontic Treatment for Sleep Apnea

N/A
Recruiting
Led By Silvia G Capenakas, MSc
Research Sponsored by University of Alberta
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Children between the ages 8-14 years old (8-12 years old girls and 9-14 years old boys) presenting skeletal class II division 1 malocclusion with maxillary constriction
Be younger than 18 years old
Must not have
Severe oral health issues (cavities, poor oral hygiene)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 years
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to find out if orthodontic treatment can help children with breathing impairments by increasing the upper airway volume.

Who is the study for?
This trial is for children aged 8-14 with a specific dental misalignment (skeletal class II division 1 malocclusion) and narrowed upper jaw. It's not open to those who've had previous orthodontic treatment, aren't likely to follow the study rules, have serious dental problems like cavities or bad hygiene, or have genetic syndromes.
What is being tested?
The study tests whether two orthodontic treatments can improve breathing in kids by changing the shape and size of their airways. One group will first use a Hyrax device then switch to a Twin block brace; another group does this in reverse order.
What are the potential side effects?
Orthodontic devices like Hyrax and Twin block may cause discomfort, pain, speech difficulties, changes in chewing function, and possible irritation inside the mouth.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My child is 8-14 years old with a specific type of jaw misalignment and a narrow upper jaw.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have severe dental problems.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Airflow
Secondary study objectives
Dental changes
Skeletal changes

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Experimental Treatment
Active Control
Group I: Twin Block then HyraxExperimental Treatment1 Intervention
Patients will undergo mandibular advancement prior to maxillary expansion using Twin block prior to Hyrax
Group II: Hyrax then Twin blockExperimental Treatment1 Intervention
Patients will undergo maxillary expansion prior to mandibular advancement using Hyrax prior to Twin block
Group III: ControlActive Control1 Intervention
Patients will wait 1,5 years before the start of treatment

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor
942 Previous Clinical Trials
434,319 Total Patients Enrolled
8 Trials studying Apnea
288 Patients Enrolled for Apnea
Silvia G Capenakas, MScPrincipal InvestigatorUniversity of Alberta

Media Library

Hyrax then Twin block (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT04190953 — N/A
Apnea Research Study Groups: Hyrax then Twin block, Control, Twin Block then Hyrax
Apnea Clinical Trial 2023: Hyrax then Twin block Highlights & Side Effects. Trial Name: NCT04190953 — N/A
Hyrax then Twin block (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04190953 — N/A
~2 spots leftby Feb 2025
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