Treatment of Class III Malocclusion Using Modified Fixed Mandibular Retractor Appliance

NCT03354442 | Completed DMC

• 1 other identifier: UDDS-Ortho-08-2017
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

This experimental study aims to evaluate the efficiency of the Modified Fixed Mandibular Retractor 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 untreated control group. The soft and hard tissue changes will be assessed using lateral cephalometric radiographs before the treatment and after obtaining 3mm positive overjet.

Conditions

Malocclusion, Angle Class III

Keywords

Class III treatment; Modified Fixed Mandibular Retractor Appliance; RCT

Outcome Measures

Primary Outcomes (1)

• ANB angle changes

  ANB angle changes before and after treatment will be assessed and compared with those of the control group using lateral cephalometric radiographs.

  Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months

Secondary Outcomes (5)

• SNA angle changes

  Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months

• SNB angle changes

  Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months

• Profile changes

  Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months

• Upper incisor angle changes

  Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months

• Lower incisor angle changes

  Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months

Study Arms (2)

Modified Fixed Mandibular Retractor

EXPERIMENTAL

All patients in this group will be treated using Modified Fixed Mandibular Retractor Appliance. This appliance will be used full-time.

Device: Modified Fixed Mandibular Retractor Appliance

Untreated control group

NO INTERVENTION

All patients in this group will be observed during the period of treating the patients in the other group to assess the growth changes.

Interventions

Modified Fixed Mandibular Retractor Appliance DEVICE

All patients with Class III malocclusion will be treated using the Modified Fixed Mandibular Retractor Appliance

Modified Fixed Mandibular Retractor

Eligibility Criteria

• Age: 7 Years - 9 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Patients in early mixed dentation (7-9 years old).
• Skeletal class III caused by mandibular prognathism with or without maxillary deficiency judged clinically and confirmed radiographically (ANB≤1).
• Anterior crossbite on two teeth or more.
• Normal inclination of the lower incisors with the mandibular plane.
• Good oral hygiene.

You may not qualify if:

• Poor oral hygiene.
• Previous orthodontic treatment.
• Patients with syndromes, clefts, or craniofacial abnormalities.
• Severe skeletal class III resulting primarily from mandibular prognathism (ANB less than - 4 with no functional shift on closure)
• 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 (6)

• Alhaija ES. Skeletal, dental and soft tissue changes in postural class III malocclusion treated with a maxillary removable appliance. J Clin Pediatr Dent. 2006 Winter;31(2):149-52. doi: 10.17796/jcpd.31.2.u286433up81kt472.

  PMID: 17315814 BACKGROUND

• Akin M, Ucar FI, Chousein C, Sari Z. Effects of chincup or facemask therapies on the orofacial airway and hyoid position in Class III subjects. J Orofac Orthop. 2015 Nov;76(6):520-30. doi: 10.1007/s00056-015-0315-3.

  PMID: 26446505 BACKGROUND

• Majanni AM, Hajeer MY. The Removable Mandibular Retractor vs the Bone-anchored Intermaxillary Traction in the Correction of skeletal class III Malocclusion in children: A Randomized Controlled Trial. J Contemp Dent Pract. 2016 May 1;17(5):361-71. doi: 10.5005/jp-journals-10024-1856.

  PMID: 27443361 BACKGROUND

• Seehra J, Fleming PS, Mandall N, Dibiase AT. A comparison of two different techniques for early correction of Class III malocclusion. Angle Orthod. 2012 Jan;82(1):96-101. doi: 10.2319/032011-197.1. Epub 2011 Aug 1.

  PMID: 21806467 BACKGROUND

• Atalay Z, Tortop T. Dentofacial effects of a modified tandem traction bow appliance. Eur J Orthod. 2010 Dec;32(6):655-61. doi: 10.1093/ejo/cjp153. Epub 2010 Mar 26.

  PMID: 20348164 BACKGROUND

• Kapur A, Chawla HS, Utreja A, Goyal A. Early class III occlusal tendency in children and its selective management. J Indian Soc Pedod Prev Dent. 2008 Sep;26(3):107-13. doi: 10.4103/0970-4388.43191.

  PMID: 18923222 BACKGROUND

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: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: A person who is not related to the research will paste a piece of paper over the Patient's name and the date of the photo then will give each x-ray a code and blind these codes on the researcher during the assessing process.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2017
• First Posted: November 28, 2017
• Study Start: May 15, 2017
• Primary Completion: December 20, 2017
• Study Completion: January 10, 2019
• Last Updated: July 18, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)