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Changes Following the Treatment of Lower Jaw Protrusion Using Two Appliances

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ClinicalTrials.gov Identifier: NCT02144324
Recruitment Status : Completed
First Posted : May 22, 2014
Last Update Posted : April 21, 2015
Sponsor:
Information provided by (Responsible Party):
Damascus University

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.

Condition or disease Intervention/treatment Phase
Class III Malocclusion in Growing Patients Device: Tandem Appliance Not Applicable

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : May 2014
Actual Primary Completion Date : March 2015
Actual Study Completion Date : April 2015

Arm Intervention/treatment
Experimental: Tandem Appliance
This group of patients will receive the new appliance which is called the Tandem Appliance
Device: Tandem Appliance
We are going to use a modified version of the Tandem Appliance

No Intervention: Traditional Treatment
Patients in this group will be treated by the traditional Face Mask appliance.



Primary Outcome Measures :
  1. Change in the SNA angle [ 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. ]
    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.

  2. Change in the spatial position of Point A [ 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. ]
    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 :
  1. Change in the SNB angle [ 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. ]
    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).

  2. Change in the overjet value [ 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. ]
    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.



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Ages Eligible for Study:   8 Years to 10 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02144324


Locations
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Syrian Arab Republic
Department of Orthodontics, University of Damascus Dental School
Damascus, Syrian Arab Republic, DM20AM18
Sponsors and Collaborators
Damascus University
Investigators
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Principal Investigator: Amro Husson, DDS MSc student, Department of Orthodontics, University of Damascus Dental School
Study Chair: Ahamd Burhan, DDS MSc PhD Senior Lecturer in Orthodontics, University of Al-Baath Dental School, Hamah, Syria
Publications:
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Responsible Party: Damascus University
ClinicalTrials.gov Identifier: NCT02144324    
Other Study ID Numbers: UDDS-Ortho-01-2014
First Posted: May 22, 2014    Key Record Dates
Last Update Posted: April 21, 2015
Last Verified: April 2015
Keywords provided by Damascus University:
Maxillary protraction
Modified Tandem Appliance
Face mask therapy
Class III malocclusion
Maxillary deficiency
Additional relevant MeSH terms:
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Prognathism
Malocclusion
Malocclusion, Angle Class III
Tooth Diseases
Stomatognathic Diseases
Jaw Abnormalities
Jaw Diseases
Musculoskeletal Diseases
Mandibular Diseases
Maxillofacial Abnormalities
Craniofacial Abnormalities
Musculoskeletal Abnormalities
Stomatognathic System Abnormalities
Congenital Abnormalities