Effects of Herbst Appliance Therapy to Improve Airway Dimension
1 other identifier
interventional
28
1 country
1
Brief Summary
Herbst appliance is one of the most popular fixed functional appliances to treat orthodontic patients with small lower jaws. Since small lower jaws are reported to be one of the main reasons to induce sleep disordered breathing(SDB) of children, Herbst appliance can be used to treat SDB children. Previously no study compared the effects of Herbst appliance therapy with removable functional appliance on airway dimension, so it still remains unclear which kinds of functional appliance is more suitable for improving airway dimension. This study will assess the effect of Herbst appliance on airway dimension and compare the effects with those of twin block appliance (a popular 24 hours used removable functional appliance, and also commonly used to treat adult sleep apnea).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2012
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2012
CompletedFirst Submitted
Initial submission to the registry
February 4, 2015
CompletedFirst Posted
Study publicly available on registry
May 19, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2017
CompletedMay 4, 2018
May 1, 2018
5.3 years
February 4, 2015
May 3, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
The cephalometric measurement of dimensional change of upper way following 2-phase orthodontic treatment
The two-phase treatment effects of Herbst and twin-block appliances on the upper airway are to be compared based on the lateral cephalometric analysis at three time points (T0: pre-treatment; T1: following 1 year functional appliance treatment; T3: following 2 years fixed appliance treatment). The parameters of lateral cephalometric analysis include the measurements of the depth of pharynx, the size of soft palate and the position of the hyoid bone.
3 years two-phase treatment with functional appliance and fixed appliance
Secondary Outcomes (1)
The three-dimensional change of upper way following 2-phase orthodontic treatment in magnetic resonance images
3 years two-phase treatment with functional appliance and fixed appliance
Study Arms (2)
The Herbst appliance
ACTIVE COMPARATOROrthodontic functional appliance
Twin block appliance
ACTIVE COMPARATOROrthodontic functional appliance
Interventions
Eligibility Criteria
You may qualify if:
- \. Class II malocclusion
You may not qualify if:
- Cleft lip and palate
- Craniofacial syndrome
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Faculty of Dentistry, the University of Hong Kong
Hong Kong, Hong Kong, 00852, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yanqi Yang
The Paediatric dentistry and orthodontic department, Faculty of Dentistry, the University of Hong Kong
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
Study Record Dates
First Submitted
February 4, 2015
First Posted
May 19, 2015
Study Start
July 1, 2012
Primary Completion
October 1, 2017
Study Completion
December 1, 2017
Last Updated
May 4, 2018
Record last verified: 2018-05