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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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12 December 2020 |
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Main ID: |
NCT03354442 |
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Date of registration:
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15/11/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Treatment of Class III Malocclusion Using Modified Fixed Mandibular Retractor Appliance
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Scientific title:
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Evaluation of the Efficacy of Modified Fixed Mandibular Retractor Appliance in the Treatment of Class III Malocclusion: A Clinical Randomized Controlled Trial |
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Date of first enrolment:
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May 15, 2017 |
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Target sample size:
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44 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03354442 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
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Phase:
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N/A
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Countries of recruitment
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Syrian Arab Republic
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Contacts
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Name:
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Ahmad S Burhan, PhD. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Department of Orthodontics, Faculty of Dentistry, Damascus University, Damascus, Syria |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Age minimum:
7 Years
Age maximum:
9 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Malocclusion, Angle Class III
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Intervention(s)
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Device: Modified Fixed Mandibular Retractor Appliance
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Primary Outcome(s)
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ANB angle changes
[Time Frame: Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months]
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Secondary Outcome(s)
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Lower incisor angle changes
[Time Frame: Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months]
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SNA angle changes
[Time Frame: Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months]
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Upper incisor angle changes
[Time Frame: Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months]
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Profile changes
[Time Frame: Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months]
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SNB angle changes
[Time Frame: Changes will be evaluated before treatment and after obtaining 3mm positive overjet, which will take approximately 8 months]
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Secondary ID(s)
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UDDS-Ortho-08-2017
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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