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Changes Following the Treatment of Lower Jaw Protrusion Using Two Appliances

Primary Purpose

Class III Malocclusion in Growing Patients

Status
Completed
Phase
Not Applicable
Locations
Syrian Arab Republic
Study Type
Interventional
Intervention
Tandem Appliance
Sponsored by
Damascus University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Class III Malocclusion in Growing Patients focused on measuring Maxillary protraction, Modified Tandem Appliance, Face mask therapy, Class III malocclusion, Maxillary deficiency

Eligibility Criteria

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

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Department of Orthodontics, University of Damascus Dental School

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Tandem Appliance

Traditional Treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Change in the SNB angle
B is a point located on the mandible on the lateral cephalogram This point is used to determine the antero-posterior positioning of the mandible (lower jaw).
Change in the overjet value
Overjet is defined as the horizontal overlap between the upper an lower anterior teeth. This variable is going to be measured twice in order to see the changes that occurred in each group antero-posteriorly as a result of the provided orthodontic appliance.

Full Information

First Posted
May 16, 2014
Last Updated
April 20, 2015
Sponsor
Damascus University
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1. Study Identification

Unique Protocol Identification Number
NCT02144324
Brief Title
Changes Following the Treatment of Lower Jaw Protrusion Using Two Appliances
Official Title
A Comparison of the Skeletal and Dento-alveolar Changes After Treatment of Class III Malocclusion With a Modified Tandem Appliance Versus the Face Mask
Study Type
Interventional

2. Study Status

Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
April 2015 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
Maxillary deficiency or retrusion is generally accepted as one of the most difficult and complex orthodontic anomalies to diagnose and treat. Facemask therapy is usually preferred for the treatment of subjects with skeletal and dental Class III malocclusions with a retruded maxilla, and it is known that if the patient is sufficiently motivated to wear a facemask, this type of therapy is quite successful. patient compliance required during facemask therapy due to its poor aesthetics and intraoral appliances for Class III malocclusion treatment such as the Fränkel III , bionator III don't give treatment goals .Hybrid appliance tandem traction bow appliance (TTBA)is introduced by Chun et al. 1999 , as a more aesthetic, effective and comfortable device. Klempner, 2003 modified tandem appliance and published two case reports suggested that TTBA and modified applications have a similar treatment effect to that of an expander-facemask combination(2). A review of the literature showed that there were no statistical studies documenting the effects of modified tandem appliance comparing to traditional expander-facemask therapy and these are the investigators study purposes. Study design: patients aged between 8-10 with anterior cross bite will be selected from orthodontic department in faculty of dentistry in Damascus university. Pretreatment cephalometric radiography will be taken. Subjects follow inclusion criteria (Skeletal Class III (ANB < 0 degree), 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,,no congenitally missing teeth or congenital syndromes such as a cleft lip/palate will be . Patient will divided to two group tandem group and face mask group depended on growth pattern. Where from patients in face mask group have normal or horizontal growth pattern,tandem group have vertical one. Appliance Design The Tandem Appliance comprises three separate components,two fixed and one removable. The upper section is a fixed McNamara expander with buccal arms soldered for attachment of protraction elastics. The lower section is consist of two bands with buccal headgear tubes and buccolingual welded arch for support . Third one is head-gear facebow inserted into the lower tubes and the outer bows bent out for elastics attachment. At the beginning of treatment, patients or Panther are instructed to wear the appliance with light, 8oz /14-16/ hours a day training elastics from the outer face-bow to the buccal arms of the upper expander. Subsequently, heavy orthopedic traction with 14oz /14-16/ hours a day,elastics effectively delivers the protraction force to the maxilla. Lateral cephalometric radiographs without the expander will be taken after a Class I molar relationship and a minimum overjet of 2 mm is obtained. Pre-treatment and post-treatment lateral cephalmetric dentofacial , sagittal and vertical skeletal parameters will be retraced by the author . Statistical analysis will be undertaken using the Statistical Package for Social Sciences, Windows version 19.0 (SPSS Inc., Chicago, Illinois, USA) Paired t-test will be used to evaluate the treatment effects and changes in same group. In depended t-test will be used to evaluate the treatment effects I between groups. confidence level 95% (P< 0.05).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Class III Malocclusion in Growing Patients
Keywords
Maxillary protraction, Modified Tandem Appliance, Face mask therapy, Class III malocclusion, Maxillary deficiency

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tandem Appliance
Arm Type
Experimental
Arm Description
This group of patients will receive the new appliance which is called the Tandem Appliance
Arm Title
Traditional Treatment
Arm Type
No Intervention
Arm Description
Patients in this group will be treated by the traditional Face Mask appliance.
Intervention Type
Device
Intervention Name(s)
Tandem Appliance
Intervention Description
We are going to use a modified version of the Tandem Appliance
Primary Outcome Measure Information:
Title
Change in the SNA angle
Description
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.
Time Frame
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.
Title
Change in the spatial position of Point A
Description
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
Time Frame
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 Outcome Measure Information:
Title
Change in the SNB angle
Description
B is a point located on the mandible on the lateral cephalogram This point is used to determine the antero-posterior positioning of the mandible (lower jaw).
Time Frame
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.
Title
Change in the overjet value
Description
Overjet is defined as the horizontal overlap between the upper an lower anterior teeth. This variable is going to be measured twice in order to see the changes that occurred in each group antero-posteriorly as a result of the provided orthodontic appliance.
Time Frame
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.

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: 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. Exclusion Criteria: Congenitally missing teeth or congenital syndromes such as a cleft lip/palate History of previous orthodontic treatment
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amro Husson, DDS
Organizational Affiliation
MSc student, Department of Orthodontics, University of Damascus Dental School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ahamd Burhan, DDS MSc PhD
Organizational Affiliation
Senior Lecturer in Orthodontics, University of Al-Baath Dental School, Hamah, Syria
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Orthodontics, University of Damascus Dental School
City
Damascus
ZIP/Postal Code
DM20AM18
Country
Syrian Arab Republic

12. IPD Sharing Statement

Citations:
PubMed Identifier
20348164
Citation
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.
Results Reference
background
PubMed Identifier
10895664
Citation
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.
Results Reference
background
PubMed Identifier
12747076
Citation
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.
Results Reference
background
PubMed Identifier
21778583
Citation
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.
Results Reference
background

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Changes Following the Treatment of Lower Jaw Protrusion Using Two Appliances

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