Changes Following the Treatment of Lower Jaw Protrusion Using Two Appliances

NCT02144324 | Completed DMC

• 1 other identifier: UDDS-Ortho-01-2014
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

An in vivo study evaluating the efficacy of the Tandem appliance in the treatment of maxillary deficiency in growing patients compared to the conventional facemask appliance treatment. Pre-treatment and post-treatment lateral cephalograms will be taken. Dentofacial, sagittal and vertical skeletal measurements will be taken at three assessment times. Changes within each group will be assessed. In addition, the changes between the two groups will be compared.

Conditions

Class III Malocclusion in Growing Patients

Keywords

Maxillary protraction; Modified Tandem Appliance; Face mask therapy; Class III malocclusion; Maxillary deficiency

Outcome Measures

Primary Outcomes (2)

• Change in the SNA angle

  This variable is measured on the lateral cephalogram taken at two time points. This variable is used to give an information about the relative position of the upper jaw in relation to the anterior cranial base.

  This variable will be measured twice: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment.

• Change in the spatial position of Point A

  Point A is defined as the point at the maximum concavity of the anterior upper alveolus (containing the upper incisors). The horizontal distance between Point A and the N-perpendicular will be also used to determine the antero-posterior positioning of Point A before and after treatment

  This variable will be measured twice: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment.

Secondary Outcomes (2)

• Change in the SNB angle

  This variable will be measured twice: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment.

• Change in the overjet value

  This variable will be measured twice: (T1) baseline measurement at seven days before the beginning of treatment and (T2) at seven days following the end of treatment.

Study Arms (2)

Tandem Appliance

EXPERIMENTAL

This group of patients will receive the new appliance which is called the Tandem Appliance

Device: Tandem Appliance

Traditional Treatment

NO INTERVENTION

Patients in this group will be treated by the traditional Face Mask appliance.

Interventions

Tandem Appliance DEVICE

We are going to use a modified version of the Tandem Appliance

Tandem Appliance

Eligibility Criteria

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

You may qualify if:

• Skeletal Class III (ANB angle \< 0 degree) with due to maxillary retrusion, or a combination of maxillary retrusion and mandibular protrusion.
• Angle Class III malocclusion with an anterior crossbite.
• An optimum SN/GoGn angle (between 26 and 38 degrees).
• Fully erupted maxillary incisors.

You may not qualify if:

• Congenitally missing teeth or congenital syndromes such as a cleft lip/palate
• History of previous orthodontic treatment

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Orthodontics, University of Damascus Dental School

Damascus, Rif-dimashq Governorate, DM20AM18, Syria

Location

Related Publications (5)

• 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

• Chun YS, Jeong SG, Row J, Yang SJ. A new appliance for orthopedic correction of Class III malocclusion. J Clin Orthod. 1999 Dec;33(12):705-11. No abstract available.

  PMID: 10895664 BACKGROUND

• Klempner LS. Early orthopedic Class III treatment with a modified tandem appliance. J Clin Orthod. 2003 Apr;37(4):218-23; quiz 204. No abstract available.

  PMID: 12747076 BACKGROUND

• Klempner L. Early treatment of skeletal Class III open bite with the Tandem Appliance. J Clin Orthod. 2011 Jun;45(6):308-16; quiz 339. No abstract available.

  PMID: 21778583 BACKGROUND

• Owens D, Watkinson S, Harrison JE, Turner S, Worthington HV. Orthodontic treatment for prominent lower front teeth (Class III malocclusion) in children. Cochrane Database Syst Rev. 2024 Apr 10;4(4):CD003451. doi: 10.1002/14651858.CD003451.pub3.

  PMID: 38597341 DERIVED

MeSH Terms

Conditions

Malocclusion, Angle Class III; Retrognathia

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases; Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Mandibular Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Amro Husson, DDS

  MSc student, Department of Orthodontics, University of Damascus Dental School

  PRINCIPAL INVESTIGATOR

• Ahamd Burhan, DDS MSc PhD

  Senior Lecturer in Orthodontics, University of Al-Baath Dental School, Hamah, Syria

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2014
• First Posted: May 22, 2014
• Study Start: May 1, 2014
• Primary Completion: March 1, 2015
• Study Completion: April 1, 2015
• Last Updated: April 21, 2015

Record last verified: 2015-04

Locations

SY (1)