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CompletedNCT03252782Updated Feb 20, 2019

Comparison of Distalization and Functional Appliance Therapy

An interventional study of Herbst Appliance and Distal Jet Appliance in Mandibular Retrognathism, sponsored by Izmir Katip Celebi University. Completed. Open to participants aged 9 Years to 14 Years. Per ClinicalTrials.gov, last updated 2019-02-20.

Sponsored by Izmir Katip Celebi University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year after the study started (first participant enrolled Aug 2016, registered Aug 2017).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
9 Years to 14 Years
Sex
All
01

Study summary

The correction of Class II malocclusion is one of the most common problems facing the orthodontist, with an estimated one-third of all orthodontic patients treated for this condition. Many strategies are available for Class II treatment on growing patients, and most orthodontists tend to choose a treatment protocol based on what part of the craniofacial deformity they believe the appliance will affect the most. A number of authors have described the dentoalveolar and skeletal changes induced by the Herbst appliance. The dentoalveolar effects consist of distalization of the maxillary molars and forward movement of the mandibular dentition. The main skeletal change "mandibular stimulation" is acceleration of a patient's inherent mandibular growth rather than increased growth beyond what would occur without treatment. Maxillary molar distalization, is one of the Class II treatment. Mini-implants have become popular in recent years, and various kinds of mini-implant-borne distalization approaches have been described. Because Class II correction appears to be achievable with either appliance, a follow-up question is whether there is a difference in the esthetic outcomes. However, because of the complexity of the human face and the subjectivity of facial beauty, a simple set of measures of lines or angles cannot quantify facial beauty. With the advances in 3-dimensional imaging, it is now possible to capture and superimpose digital images and measure the changes in the soft tissues from 3-dimensional images. Such advances in facial imaging allow a more thorough investigation of changes in 3 dimensions and prevent the inherent loss of information that results from 2-dimensional imaging. Optical scanners with short shutter speeds are convenient for clinicians and patients for capturing soft-tissue records. Bearing in mind that the aim of orthodontic treatment is to achieve facial harmony along with excellent occlusion, one of the most important objectives of an orthodontist should be the improvement of facial appearance. Therefore, it is important to gain a better understanding of how or whether orthodontic procedures affect the appearance of the soft tissues. Thus, the aim of this clinical trial is three dimensional evaluation of soft tissue facial changes on late mixed dentition patients following maxillary arch distalization with palatal screws one group and acrylic split herbst patients on other group and to compare these changes.

Read the detailed description

The correction of Class II malocclusion is one of the most common problems facing the orthodontist, with an estimated one-third of all orthodontic patients treated for this condition.

Many strategies are available for Class II treatment on growing patients, and most orthodontists tend to choose a treatment protocol based on what part of the craniofacial deformity they believe the appliance will affect the most.

A number of authors have described the dentoalveolar and skeletal changes induced by the Herbst appliance. The dentoalveolar effects consist of distalization of the maxillary molars and forward movement of the mandibular dentition. The main skeletal change "mandibular stimulation" is acceleration of a patient's inherent mandibular growth rather than increased growth beyond what would occur without treatment.

Maxillary molar distalization, is one of the Class II treatment. Mini-implants have become popular in recent years, and various kinds of mini-implant-borne distalization approaches have been described.

Because Class II correction appears to be achievable with either appliance, a follow-up question is whether there is a difference in the esthetic outcomes. However, because of the complexity of the human face and the subjectivity of facial beauty, a simple set of measures of lines or angles cannot quantify facial beauty.

Being the principle quantifiable diagnostic tool, the use of lateral head films lead orthodontists to have thought primarily in two dimensions. With the advances in 3-dimensional imaging, it is now possible to capture and superimpose digital images and measure the changes in the soft tissues from 3-dimensional images. Such advances in facial imaging allow a more thorough investigation of changes in 3 dimensions and prevent the inherent loss of information that results from 2-dimensional imaging. Optical scanners with short shutter speeds are convenient for clinicians and patients for capturing soft-tissue records.

Bearing in mind that the aim of orthodontic treatment is to achieve facial harmony along with excellent occlusion, one of the most important objectives of an orthodontist should be the improvement of facial appearance. Therefore, it is important to gain a better understanding of how or whether orthodontic procedures affect the appearance of the soft tissues. Thus, the aim of this clinical trial is three dimensional evaluation of soft tissue facial changes on late mixed dentition patients following maxillary arch distalization with palatal screws one group and acrylic split herbst patients on other group and to compare these changes.

02

Conditions studied

  • Mandibular Retrognathism

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Keywords

  • Soft Tissue
  • Functional Appliance
  • Maxillary Molar Distalization
03

In context

Retrognathia

62 studies on the registry are indexed under Retrognathia; 15 are open to participants now.

This study's enrollment of 30 is below the median of 34 across 52 interventional studies indexed under Retrognathia.

Browse Retrognathia studies →

Lead sponsor

Izmir Katip Celebi University is the lead sponsor of 198 studies on the registry; 39 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
9 Years to 14 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Angle Class II molar relation, Skeletal Class II depends on mandibular retrognathia , Crowding less than 4 mm, Normal growth pattern, No systematic or oral disease, No previous orthodontic treatment

Exclusion criteria

Exclusion Criteria:

Missing teeth, Severe facial asymmetry, Poor oral hygiene

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Active comparator
    Functional Treatment

    Acrylic Splint Herbst Appliance

    Device: Herbst Appliance

  • Active comparator
    Distalization Treatment

    Mini-implant-borne Distal Jet Appliance

    Device: Distal Jet Appliance

Interventions

  • DeviceHerbst Appliance

    Acrylic Splint Herbst Appliance

  • DeviceDistal Jet Appliance

    Anterior Median Palate Implant Borne Distal Jet Appliance

06

What researchers measure

Primary outcomes

  1. Soft Tissue Difference

    Three-Dimensional Soft Tissue Changes Before and After Treatment

    Time frame: Estimated 1 year

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 20, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03252782
Responsible party
Asli Baysal (Associate Professor, Izmir Katip Celebi University) — Principal investigator
First posted
Aug 17, 2017
Start date
Aug 1, 2016
Primary completion
Mar 30, 2018
Completion
Jun 1, 2018
Last update
Feb 20, 2019

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2019. You cannot join it, but the record below documents what was studied.

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