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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: |
NCT03172442 |
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Date of registration:
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23/05/2017 |
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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 Skeletal Class III Malocclusion Using Orthodontic Removable Traction Appliance
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Scientific title:
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Dentoskeletal Effects of The Orthodontic Removable Traction Appliance in The Treatment of Skeletal Class III Malocclusion: A Randomized Controlled Trial |
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Date of first enrolment:
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May 1, 2017 |
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Target sample size:
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22 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT03172442 |
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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: None (Open Label).
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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 (8-10 years old).
- Skeletal class III caused by maxillary deficiency with or without mandibular
prognathism judged clinically and confirmed radiographically(ANB=1).
- Anterior crossbite on two teeth or more or an edge-to-edge bite.
- Normal inclination of the lower incisors with the mandibular plane.
Exclusion Criteria:
- Poor oral hygiene.
- Previous orthodontic treatment.
- Patients with syndromes, clefts, or craniofacial abnormalities.
- Severe skeletal class III primarily resulting from mandibular prognathism (ANB less
than - 4)
- Patients with facial asymmetry.
- Patients with vertical growth pattern.
Age minimum:
8 Years
Age maximum:
10 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Class III Malocclusion
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Intervention(s)
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Device: Class III elastics
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Device: Vacuum plate
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Device: Rapid maxillary expander
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Primary Outcome(s)
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The change of the ANB angle
[Time Frame: Assessment will be done before treatment (T0) and after obtaining 3-mm positive overjet which will be approximately obtained after 6 months (T1).]
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Secondary Outcome(s)
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Levels of pain
[Time Frame: A questionnaire will be given to the patients four times during treatment; after 1day, after 1 week, after 1 month and after 3 months of the application of the appliance.]
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The change of the SNB angle
[Time Frame: Assessment will be done before treatment (T0) and after obtaining 3-mm positive overjet which will be approximately obtained after 6 months (T1).]
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Levels of discomfort
[Time Frame: A questionnaire will be given to the patients four times during treatment; after 1day, after 1 week, after 1 month and after 3 months of the application of the appliance.]
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The change of the SNA angle
[Time Frame: Assessment will be done before treatment (T0) and after obtaining 3-mm positive overjet which will be approximately obtained after 6 months (T1).]
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Levels of acceptance
[Time Frame: A questionnaire will be given to the patients four times during treatment; after 1day, after 1 week, after 1 month and after 3 months of the application of the appliance.]
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Secondary ID(s)
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UDDS-Ortho-03-2017
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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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