Treatment of Skeletal Class III Malocclusion Using Orthodontic Removable Traction Appliance

Class III Malocclusion Clinical Trial

Official title:

Dentoskeletal Effects of The Orthodontic Removable Traction Appliance in The Treatment of Skeletal Class III Malocclusion: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03172442
• Other study ID #: UDDS-Ortho-03-2017
• Status: Completed
• Phase: N/A
• Start date: May 1, 2017
• Est. completion date: February 15, 2019

Study information

• Verified date: July 2019
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: February 15, 2019
• Est. primary completion date: December 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 10 Years

Eligibility

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.

Related Conditions & MeSH terms

• Class III Malocclusion
• Malocclusion
• Malocclusion, Angle Class III
• Prognathism

Intervention

Device:
• Vacuum plate
Vacuum plate with two hooks between lateral incisor and canine in each side will be applied on the lower arch.
• Rapid maxillary expander
Rapid maxillary expander will be applied in the maxilla to disarticulate maxillary sutures to allow more efficient forward protraction of the maxilla.
• Class III elastics
Class III elastic traction from upper first molar to the hook in both side will be applied.

Locations

Country	Name	City	State
Syrian Arab Republic	Damascus University	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (5)

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. — View 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. — View 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 foll — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Assessment will be done before treatment (T0) and after obtaining 3-mm positive overjet which will be approximately obtained after 6 months (T1).
Secondary	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.	Assessment will be done before treatment (T0) and after obtaining 3-mm positive overjet which will be approximately obtained after 6 months (T1).
Secondary	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.	Assessment will be done before treatment (T0) and after obtaining 3-mm positive overjet which will be approximately obtained after 6 months (T1).
Secondary	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).	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.
Secondary	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).	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.
Secondary	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).	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.