search
Back to results

Treatment of Skeletal Class III Malocclusion Using Orthodontic Removable Traction Appliance

Primary Purpose

Class III Malocclusion

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Vacuum plate
Rapid maxillary expander
Class III elastics
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Class III Malocclusion focused on measuring Class III treatment, orthodontic removable traction appliance, RCT

Eligibility Criteria

8 Years - 10 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients in early mixed dentation (8-10 years old).
  • Skeletal class III caused by maxillary deficiency with or without mandibular prognathism judged clinically and confirmed radiographically(ANB≤1).
  • Anterior crossbite on two teeth or more or an edge-to-edge bite.
  • Normal inclination of the lower incisors with the mandibular plane.

Exclusion Criteria:

  • Poor oral hygiene.
  • Previous orthodontic treatment.
  • Patients with syndromes, clefts, or craniofacial abnormalities.
  • Severe skeletal class III primarily resulting from mandibular prognathism (ANB less than - 4)
  • Patients with facial asymmetry.
  • Patients with vertical growth pattern.

Sites / Locations

  • Damascus University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

orthodontic removable traction appliance

Control group

Arm Description

Patients in this group will be treated using the orthodontic removable traction appliance (vacuum plate with two hooks between lateral incisor and canine in each side). An rapid maxillary expander will be applied to disarticulate maxillary sutures to allow more efficient forward protraction of the maxilla. Class III elastic traction from upper first molar to the hook in both side. This appliance will be used full-time with Class III elastics (6- to 8-ounce) traction.

without intervention

Outcomes

Primary Outcome Measures

The change of the ANB angle
The change of the ANB angle before and after using the Orthodontic Removable Traction Appliance compared with this of the control group will be evaluated using lateral cephalometric radiographs.

Secondary Outcome Measures

The change of the SNA angle
The change of the SNA angle before and after using the Orthodontic Removable Traction Appliance compared with this of the control group will be evaluated using lateral cephalometric radiographs.
The change of the SNB angle
The change of the SNB angle before and after using the Orthodontic Removable Traction Appliance compared with this of the control group will be evaluated using lateral cephalometric radiographs.
Levels of pain
The level of Pain caused by using the Orthodontic Removable Traction Appliance will be assessed using a questionnaire with a Visual Analog Scale (VAS).
Levels of discomfort
The level of discomfort caused by using the Orthodontic Removable Traction Appliance will be assessed using a questionnaire with a Visual Analog Scale (VAS).
Levels of acceptance
The level of acceptance of using the Orthodontic Removable Traction Appliance will be assessed using a questionnaire with a Visual Analog Scale (VAS).

Full Information

First Posted
May 23, 2017
Last Updated
July 16, 2019
Sponsor
Damascus University
search

1. Study Identification

Unique Protocol Identification Number
NCT03172442
Brief Title
Treatment of Skeletal Class III Malocclusion Using Orthodontic Removable Traction Appliance
Official Title
Dentoskeletal Effects of The Orthodontic Removable Traction Appliance in The Treatment of Skeletal Class III Malocclusion: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
May 1, 2017 (Actual)
Primary Completion Date
December 15, 2017 (Actual)
Study Completion Date
February 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Damascus University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This experimental study aims to evaluate the efficiency of the orthodontic removable traction appliance in the treatment of skeletal class III malocclusion. The study sample will consist of 44 patients with skeletal class III malocclusion. The sample will be allocated randomly into two groups: experimental group and control group. The dentoskeletal changes will be assessed by using lateral cephalometric radiographs before treatment and after obtaining 3mm positive overjet.
Detailed Description
Treatment of class III malocclusion is a major challenge in orthodontic contemporary practice, Several appliance have suggested for the treatment of class III malocclusion, such as the facial mask and chin cup. Despite of the efficiency of this extraoral appliance, its external appearance and its big size reduce patients' cooperation which decrease its clinical effects. Another Class III treatment modality is the Orthodontic Removable Traction Appliance (ORTA). It is a removable appliance that can be used in conjunction with rapid palatal expansion or fixed appliances, It was developed in the 1980's by Dr. David Musich who developed this appliance in order to overcome issues of compliance that Dr. Musich experienced with use of the protraction facemask. There is only one study that evaluated this appliance which is a retrospective study compared the treatment effects of the ORTA and protraction facemask in treatment of Class III malocclusions. However, this study has a lot of limitations which made it difficult to accurately evaluate the efficiency of this device. The aim of this study is studying the dentoskeletal changes that result from treatment by this device, by comparing them to the changes in matched untreated group,by studying the cephalometric x-rays.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class III Malocclusion
Keywords
Class III treatment, orthodontic removable traction appliance, RCT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The patients will be randomly assigned to one of the two groups, case or control.
Masking
None (Open Label)
Masking Description
No masking could be applied
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
orthodontic removable traction appliance
Arm Type
Experimental
Arm Description
Patients in this group will be treated using the orthodontic removable traction appliance (vacuum plate with two hooks between lateral incisor and canine in each side). An rapid maxillary expander will be applied to disarticulate maxillary sutures to allow more efficient forward protraction of the maxilla. Class III elastic traction from upper first molar to the hook in both side. This appliance will be used full-time with Class III elastics (6- to 8-ounce) traction.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
without intervention
Intervention Type
Device
Intervention Name(s)
Vacuum plate
Intervention Description
Vacuum plate with two hooks between lateral incisor and canine in each side will be applied on the lower arch.
Intervention Type
Device
Intervention Name(s)
Rapid maxillary expander
Intervention Description
Rapid maxillary expander will be applied in the maxilla to disarticulate maxillary sutures to allow more efficient forward protraction of the maxilla.
Intervention Type
Device
Intervention Name(s)
Class III elastics
Intervention Description
Class III elastic traction from upper first molar to the hook in both side will be applied.
Primary Outcome Measure Information:
Title
The change of the ANB angle
Description
The change of the ANB angle before and after using the Orthodontic Removable Traction Appliance compared with this of the control group will be evaluated using lateral cephalometric radiographs.
Time Frame
Assessment will be done before treatment (T0) and after obtaining 3-mm positive overjet which will be approximately obtained after 6 months (T1).
Secondary Outcome Measure Information:
Title
The change of the SNA angle
Description
The change of the SNA angle before and after using the Orthodontic Removable Traction Appliance compared with this of the control group will be evaluated using lateral cephalometric radiographs.
Time Frame
Assessment will be done before treatment (T0) and after obtaining 3-mm positive overjet which will be approximately obtained after 6 months (T1).
Title
The change of the SNB angle
Description
The change of the SNB angle before and after using the Orthodontic Removable Traction Appliance compared with this of the control group will be evaluated using lateral cephalometric radiographs.
Time Frame
Assessment will be done before treatment (T0) and after obtaining 3-mm positive overjet which will be approximately obtained after 6 months (T1).
Title
Levels of pain
Description
The level of Pain caused by using the Orthodontic Removable Traction Appliance will be assessed using a questionnaire with a Visual Analog Scale (VAS).
Time Frame
A questionnaire will be given to the patients four times during treatment; after 1day, after 1 week, after 1 month and after 3 months of the application of the appliance.
Title
Levels of discomfort
Description
The level of discomfort caused by using the Orthodontic Removable Traction Appliance will be assessed using a questionnaire with a Visual Analog Scale (VAS).
Time Frame
A questionnaire will be given to the patients four times during treatment; after 1day, after 1 week, after 1 month and after 3 months of the application of the appliance.
Title
Levels of acceptance
Description
The level of acceptance of using the Orthodontic Removable Traction Appliance will be assessed using a questionnaire with a Visual Analog Scale (VAS).
Time Frame
A questionnaire will be given to the patients four times during treatment; after 1day, after 1 week, after 1 month and after 3 months of the application of the appliance.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients in early mixed dentation (8-10 years old). Skeletal class III caused by maxillary deficiency with or without mandibular prognathism judged clinically and confirmed radiographically(ANB≤1). Anterior crossbite on two teeth or more or an edge-to-edge bite. Normal inclination of the lower incisors with the mandibular plane. Exclusion Criteria: Poor oral hygiene. Previous orthodontic treatment. Patients with syndromes, clefts, or craniofacial abnormalities. Severe skeletal class III primarily resulting from mandibular prognathism (ANB less than - 4) Patients with facial asymmetry. Patients with vertical growth pattern.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahmad S Burhan, PhD.
Organizational Affiliation
Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria
Official's Role
Study Chair
Facility Information:
Facility Name
Damascus University
City
Damascus
ZIP/Postal Code
00963
Country
Syrian Arab Republic

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual participant data will be available to the researchers in the department of Orthodontics, Damascus University
Citations:
PubMed Identifier
12607852
Citation
Cha KS. Skeletal changes of maxillary protraction in patients exhibiting skeletal class III malocclusion: a comparison of three skeletal maturation groups. Angle Orthod. 2003 Feb;73(1):26-35. doi: 10.1043/0003-3219(2003)0732.0.CO;2.
Results Reference
result
PubMed Identifier
20805344
Citation
Mandall N, DiBiase A, Littlewood S, Nute S, Stivaros N, McDowall R, Shargill I, Worthington H, Cousley R, Dyer F, Mattick R, Doherty B. Is early Class III protraction facemask treatment effective? A multicentre, randomized, controlled trial: 15-month follow-up. J Orthod. 2010 Sep;37(3):149-61. doi: 10.1179/14653121043056.
Results Reference
result
PubMed Identifier
19524831
Citation
Gautam P, Valiathan A, Adhikari R. Skeletal response to maxillary protraction with and without maxillary expansion: a finite element study. Am J Orthod Dentofacial Orthop. 2009 Jun;135(6):723-8. doi: 10.1016/j.ajodo.2007.06.016.
Results Reference
result
PubMed Identifier
3075214
Citation
Turley PK. Orthopedic correction of Class III malocclusion with palatal expansion and custom protraction headgear. J Clin Orthod. 1988 May;22(5):314-25. No abstract available.
Results Reference
result
PubMed Identifier
10893473
Citation
Suda N, Ishii-Suzuki M, Hirose K, Hiyama S, Suzuki S, Kuroda T. Effective treatment plan for maxillary protraction: is the bone age useful to determine the treatment plan? Am J Orthod Dentofacial Orthop. 2000 Jul;118(1):55-62. doi: 10.1067/mod.2000.104491.
Results Reference
result

Learn more about this trial

Treatment of Skeletal Class III Malocclusion Using Orthodontic Removable Traction Appliance

We'll reach out to this number within 24 hrs