Malocclusion, Angle Class II Clinical Trial
Official title:
"Three Dimensional Assessment of Maxillary Molars Following Distalization Using Two Different Approaches"
NCT number | NCT06240923 |
Other study ID # | ORD 16-6M |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2, 2017 |
Est. completion date | June 23, 2022 |
Verified date | February 2024 |
Source | Ain Shams University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The goal of this controlled clinical trial is to compare the effects of two distalization methods supported by inter-radicular mini-screw for maxillary molars distalization in 20 adult patients with skeletal class I or moderate skeletal class II malocclusion, dental class II molar relationship, and full permanent dentition. The participants were randomly selected according to inclusion / exclusion criteria from the outpatient clinic of the Department of Orthodontics and Dentofacial Orthopedics, Faculty of dentistry, Ain Shams University, Cairo, Egypt. Selectees age was ranging from 18 to 25 years old. An informed consent has been signed by each patient before his / her enrollment in this study, where the aim , methodology, and possible complications were been clearly described in details. This research has been thoroughly reviewed by the Research Ethics Committee of the Faculty of dentistry, Ain Shams University.
Status | Completed |
Enrollment | 24 |
Est. completion date | June 23, 2022 |
Est. primary completion date | March 16, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 25 Years |
Eligibility | Inclusion Criteria: 1. All subjects are free from any dental anomalies as well as periodontal and systemic diseases that may influence orthodontic treatment. 2. Adult patients with age ranging from 18 to 25 years. 3. Full permanent dentition with exclusion of third molars. 4. Both first and second maxillary molars are in occlusion. 5. Skeletal class I, mild or moderate skeletal class II malocclusion. 6. Full cusp or end to end class II molar relationship. 7. Mild to moderate crowding in the upper dental arch and / or increased overjet. 8. Normal or horizontal growth pattern. 9. Non-extraction treatment plan. Exclusion Criteria: 1. Previous orthodontic treatment. 2. Treatment planning requiring orthognathic surgery. 3. Severe molar rotation. 4. Poor oral hygiene. |
Country | Name | City | State |
---|---|---|---|
Egypt | Ain Shams University | Cairo |
Lead Sponsor | Collaborator |
---|---|
Ain Shams University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The amount of maxillary molars distalization | Primary outcome of this study is to determine the amount of maxillary molars linear distal movement distance measured in millimeters. | 8-10 months | |
Primary | The type of maxillary molars distalization | Molar tipping measured by the degree of the angle of tipping. | 8-10 months | |
Secondary | Loss of anchorage | Anterior linear displacement of the premolars measured in millimeters. | 8-10 months |
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