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Fixed Lingual Mandibular Growth Modificator (FLMGM)

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ClinicalTrials.gov Identifier: NCT01853137
Recruitment Status : Completed
First Posted : May 14, 2013
Last Update Posted : May 14, 2013
Sponsor:
Information provided by (Responsible Party):
Osama AlAli, Damascus University

Brief Summary:
The current trial was designed to investigate the possible initial net skeletal and dental effects of treatment with FLMGM by a comparative evaluation of treated and untreated Cl II/1 malocclusion subjects. The null hypothesis stated that there were no significant differences in dentofacial changes between FLMGM group and control group.

Condition or disease Intervention/treatment Phase
Class II Division 1 Malocclusion Retrognathic Mandible Device: Fixed Lingual Mandibular Growth Modificator (FLMGM) Phase 2

Detailed Description:

The study was prospective controlled clinical trial conducted at the department of Orthodontics, between May/2009 and June/2011. The protocol of study was approved by the council of scientific research and postgraduate studies.

The original study sample included 43 patients (25 treated, 18 untreated). Of the 43 patients initially enrolled, 38 completed this trial and comprised the final sample, and 5 (4 treated, 1 untreated) were excluded . All patients and parents gave prior informed consent to their inclusion in the investigation.

Patients of both groups were followed on a parallel basis during a period of 8 months and included in the trial regardless of achievement of a Class I incisor relationship. All patient of treatment group (n=21) were treated with FLMGM, and treatment was continued beyond this time point if the Class II malocclusion was not fully corrected and clinical objectives were not achieved. On the other hand, no orthodontic treatment was performed during that duration for the subjects of control group (n=17), and most of control subjects were offered suitable treatment at a later date.

For each patient, a direct digital lateral cephalogram was taken pre- and post- treatment/observation using PAX 400 (VATECH CO., Korea) with the same settings. Cephalograms were digitized on screen and analyzed in a blind manner by the same orthodontist using a cephalometric software (Viewbox, 3.1.1.13, Kifissia). . All linear measurements were reduced to life size (enlargement: 7.54%).

Pretreatment equivalence, changes occurring during the examination period in each group and comparison of changes observed in both groups were tested for significance with t-tests using SPSS . P values of less than 0.05 were considered statistically significant. To assess the method error, twenty cephalograms were randomly picked from both groups and redigitized and analyzed by the same orthodontist after 1 month, and the method error was calculated by Dahlberg's formula.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 43 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective Controlled Evaluation of Class II Division 1 Malocclusions Treated With Fixed Lingual Mandibular Growth Modificator (FLMGM)
Study Start Date : May 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : December 2012

Arm Intervention/treatment
Experimental: FLMGM Treatment Group Device: Fixed Lingual Mandibular Growth Modificator (FLMGM)
Novel Class II functional appliance, a fixed version of double-plate appliance
Other Name: Fixed Lingual Mandibular Growth Modification Appliance (FLMGMA)

No Intervention: Untreated Class II Control Group



Primary Outcome Measures :
  1. Total mandibular length (Co-Gn) [ Time Frame: 8 months ]

Secondary Outcome Measures :
  1. Overjet reduction [ Time Frame: 8 months ]

Other Outcome Measures:
  1. Standard skeletal and dental cephalometric variable [ Time Frame: 8 months ]


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Ages Eligible for Study:   11 Years to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Before treatment, each patient fulfilled the following criteria:

  1. Cl II/1 malocclusion with an overjet greater than 4 mm.
  2. Mild to moderate Class II Skeletal pattern (A-N-B > 4°) with retrognathic mandible (S-N-B < 76°).
  3. Growth potential. Fishman skeletal maturation indicator (SMI) method28 was used to assess the hand-wrist radiographs, and only patients in the peak of the pubertal growth spurt, which occurs on average between SMIs 4 to 7,29 at the beginning of the treatment/observation period were invited.

Exclusion Criteria:

-


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): NCT01853137


Locations
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Syrian Arab Republic
Department of Orthodontics, School of Dentistry, University of Damascus
Damascus, Syrian Arab Republic
Sponsors and Collaborators
Damascus University
Investigators
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Principal Investigator: Osama H Alali, PhD Assistant Professor, Department of Orthodontics, School of Dentistry, University of Damascus, Syria
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Responsible Party: Osama AlAli, Dr., Damascus University
ClinicalTrials.gov Identifier: NCT01853137    
Other Study ID Numbers: OSAMA-18-2-2013
First Posted: May 14, 2013    Key Record Dates
Last Update Posted: May 14, 2013
Last Verified: May 2013
Keywords provided by Osama AlAli, Damascus University:
Class II division 1 malocclusion
Dentofacial orthopedics
Fixed Lingual Mandibular Growth Modificator (FLMGM)
Additional relevant MeSH terms:
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Malocclusion
Malocclusion, Angle Class II
Tooth Diseases
Stomatognathic Diseases