Treatment of Skeletal Class III Malocclusion Using Orthodontic Removable Traction Appliance

NCT03172442 | Completed DMC

• 1 other identifier: UDDS-Ortho-03-2017
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Class III Malocclusion

Keywords

Class III treatment; orthodontic removable traction appliance; RCT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• The change of the SNA angle

  Assessment will be done before treatment (T0) and after obtaining 3-mm positive overjet which will be approximately obtained after 6 months (T1).

• The change of the SNB angle

  Assessment will be done before treatment (T0) and after obtaining 3-mm positive overjet which will be approximately obtained after 6 months (T1).

• Levels of pain

  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.

• Levels of discomfort

  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.

• Levels of acceptance

  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.

Study Arms (2)

orthodontic removable traction appliance

EXPERIMENTAL

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.

Device: Vacuum plate; Device: Rapid maxillary expander; Device: Class III elastics

Control group

NO INTERVENTION

without intervention

Interventions

Vacuum plate DEVICE

Vacuum plate with two hooks between lateral incisor and canine in each side will be applied on the lower arch.

orthodontic removable traction appliance

Rapid maxillary expander DEVICE

Rapid maxillary expander will be applied in the maxilla to disarticulate maxillary sutures to allow more efficient forward protraction of the maxilla.

orthodontic removable traction appliance

Class III elastics DEVICE

Class III elastic traction from upper first molar to the hook in both side will be applied.

orthodontic removable traction appliance

Eligibility Criteria

• Age: 8 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Damascus University

Damascus, 00963, Syria

Location

Related 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. doi: 10.1043/0003-3219(2003)0732.0.CO;2.

  PMID: 12607852 RESULT

• 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.

  PMID: 20805344 RESULT

• 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.

  PMID: 19524831 RESULT

• 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.

  PMID: 3075214 RESULT

• 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.

  PMID: 10893473 RESULT

MeSH Terms

Conditions

Malocclusion, Angle Class III

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Ahmad S Burhan, PhD.

  Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: No masking could be applied
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The patients will be randomly assigned to one of the two groups, case or control.

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: June 1, 2017
• Study Start: May 1, 2017
• Primary Completion: December 15, 2017
• Study Completion: February 15, 2019
• Last Updated: July 18, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will share

Locations

SY (1)