Comparison of Distalization and Functional Appliance Therapy
Primary Purpose
Mandibular Retrognathism
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Herbst Appliance
Distal Jet Appliance
Sponsored by
About this trial
This is an interventional treatment trial for Mandibular Retrognathism focused on measuring Soft Tissue, Functional Appliance, Maxillary Molar Distalization
Eligibility Criteria
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:
Missing teeth, Severe facial asymmetry, Poor oral hygiene
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Functional Treatment
Distalization Treatment
Arm Description
Acrylic Splint Herbst Appliance
Mini-implant-borne Distal Jet Appliance
Outcomes
Primary Outcome Measures
Soft Tissue Difference
Three-Dimensional Soft Tissue Changes Before and After Treatment
Secondary Outcome Measures
Full Information
NCT ID
NCT03252782
First Posted
August 15, 2017
Last Updated
February 18, 2019
Sponsor
Izmir Katip Celebi University
1. Study Identification
Unique Protocol Identification Number
NCT03252782
Brief Title
Comparison of Distalization and Functional Appliance Therapy
Official Title
Three Dimensional Stereophotogrammetric Comparison of Intraoral Maxillary Molar Distalization and Functional Mandibular Advancement on Facial Soft Tissues
Study Type
Interventional
2. Study Status
Record Verification Date
February 2019
Overall Recruitment Status
Completed
Study Start Date
August 1, 2016 (Actual)
Primary Completion Date
March 30, 2018 (Actual)
Study Completion Date
June 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Izmir Katip Celebi University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mandibular Retrognathism
Keywords
Soft Tissue, Functional Appliance, Maxillary Molar Distalization
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
2-arm parallel-group
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Functional Treatment
Arm Type
Active Comparator
Arm Description
Acrylic Splint Herbst Appliance
Arm Title
Distalization Treatment
Arm Type
Active Comparator
Arm Description
Mini-implant-borne Distal Jet Appliance
Intervention Type
Device
Intervention Name(s)
Herbst Appliance
Intervention Description
Acrylic Splint Herbst Appliance
Intervention Type
Device
Intervention Name(s)
Distal Jet Appliance
Intervention Description
Anterior Median Palate Implant Borne Distal Jet Appliance
Primary Outcome Measure Information:
Title
Soft Tissue Difference
Description
Three-Dimensional Soft Tissue Changes Before and After Treatment
Time Frame
Estimated 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
14 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
Missing teeth, Severe facial asymmetry, Poor oral hygiene
12. IPD Sharing Statement
Learn more about this trial
Comparison of Distalization and Functional Appliance Therapy
We'll reach out to this number within 24 hrs