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Effects of Herbst Appliance Therapy to Improve Airway Dimension

Primary Purpose

Angle Class II

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
The Herbst appliance
Twin block appliance
Sponsored by
The University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Angle Class II

Eligibility Criteria

11 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

1. Class II malocclusion

Exclusion Criteria:

  1. Cleft lip and palate
  2. Craniofacial syndrome

Sites / Locations

  • Faculty of Dentistry, the University of Hong Kong

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

The Herbst appliance

Twin block appliance

Arm Description

Orthodontic functional appliance

Orthodontic functional appliance

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The three-dimensional change of upper way following 2-phase orthodontic treatment in magnetic resonance images
The two-phase treatment effects of Herbst and twin-block appliances on the upper airway are to be compared based on the analyses of magnetic resonance images at three time points (T0: pre-treatment; T1: following 1 year functional appliance treatment; T3: following 2 years fixed appliance treatment).The analyses include measurements of the depth and width of pharynx, the size of soft palate and the tongue.

Full Information

First Posted
February 4, 2015
Last Updated
May 3, 2018
Sponsor
The University of Hong Kong
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1. Study Identification

Unique Protocol Identification Number
NCT02448017
Brief Title
Effects of Herbst Appliance Therapy to Improve Airway Dimension
Official Title
Effects of Herbst Appliance Therapy to Improve Airway Dimension
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
July 2012 (undefined)
Primary Completion Date
October 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Hong Kong

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).
Detailed Description
Sleep disordered breathing (SDB) is an important paediatric problem. It is estimated that 3.2% to 12.1% of children have habitual snoring and 0.7% to 10.3% have obstructive sleep apnea syndrome (OSAS). Children OSAS is associated with a series of daytime and nighttime signs and symptoms. Nighttime symptoms include heavy snoring, restless sleep, heavy seating and enuresis, etc. Daytime symptoms include excessive daytime sleepiness and abnormal behavior such as aggressiveness and hyperactivity, etc. Untreated OSAS was reported to result in serious morbidity, such as failure to thrive, poor learning, attention deficit and hyperactivity disorder, etc. There is an increasing concern related to sleep disordered breathing(SDB) of children by orthodontists. Since not only the tonsilar and adenoid hypertrophy is the main cause of paediatric OSA, but also craniofacial anomalies such as retrognathic mandible, narrow maxillary palatal arch and increased lower facial height can also contribute to it, orthopedic treatment such as rapid maxillary expansion (RME) and mandibular advancement device (MAD) may potentially permanently cure the children OSA. RME which is used to widen maxilla, thus increasing the nasal cavity and improving the nasal flow, has been thoroughly researched. However, only a few previous studies focused on the treatment effect of MAD for treating OSA children. These studies showed sorts of MAD such as jaw-positioning appliance, mono-block, and Herbst appliance were effective to OSA children, but it remains unclear how to choose a functional appliance, and if there is any treatment difference between removable functional appliance and fixed functional appliance for improving airway dimension.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Angle Class II

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
The Herbst appliance
Arm Type
Active Comparator
Arm Description
Orthodontic functional appliance
Arm Title
Twin block appliance
Arm Type
Active Comparator
Arm Description
Orthodontic functional appliance
Intervention Type
Device
Intervention Name(s)
The Herbst appliance
Intervention Description
Orthodontic functional appliance
Intervention Type
Device
Intervention Name(s)
Twin block appliance
Intervention Description
Orthodontic functional appliance
Primary Outcome Measure Information:
Title
The cephalometric measurement of dimensional change of upper way following 2-phase orthodontic treatment
Description
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.
Time Frame
3 years two-phase treatment with functional appliance and fixed appliance
Secondary Outcome Measure Information:
Title
The three-dimensional change of upper way following 2-phase orthodontic treatment in magnetic resonance images
Description
The two-phase treatment effects of Herbst and twin-block appliances on the upper airway are to be compared based on the analyses of magnetic resonance images at three time points (T0: pre-treatment; T1: following 1 year functional appliance treatment; T3: following 2 years fixed appliance treatment).The analyses include measurements of the depth and width of pharynx, the size of soft palate and the tongue.
Time Frame
3 years two-phase treatment with functional appliance and fixed appliance

10. Eligibility

Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 1. Class II malocclusion Exclusion Criteria: Cleft lip and palate Craniofacial syndrome
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yanqi Yang
Organizational Affiliation
The Paediatric dentistry and orthodontic department, Faculty of Dentistry, the University of Hong Kong
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Dentistry, the University of Hong Kong
City
Hong Kong
State/Province
Hong Kong
ZIP/Postal Code
00852
Country
China

12. IPD Sharing Statement

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Effects of Herbst Appliance Therapy to Improve Airway Dimension

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