Malocclusion, Angle Class III Clinical Trial
Official title:
Evaluation of the Efficacy of Different Anchorage-supported Appliances and Different Expansion Procedures for Face Mask Treatment in Prepubertal Children
NCT number | NCT06244563 |
Other study ID # | 102 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | June 8, 2022 |
Est. completion date | June 9, 2023 |
Verified date | February 2024 |
Source | University of Gaziantep |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to assess and compare the effect of two appliances (Hybrid-Hyrax expander/ Bonded rapid maxillary expander (RME)) supported by different anchorage units and two different expansion procedures (routine rapid maxillary expansion protocol (routine)/ alternative rapid expansion and constriction protocol (alt-RAMEC)) on maxillary protraction during face mask (FM) treatment.
Status | Completed |
Enrollment | 60 |
Est. completion date | June 9, 2023 |
Est. primary completion date | April 10, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 8 Years to 12 Years |
Eligibility | Inclusion Criteria: - Skeletal class III - Prepubertal growth stage - Reverse overjet Exclusion Criteria: - Previous orthodontic treatment history - Patients with craniofacial abnormalities and syndromes. - Systemic diseases |
Country | Name | City | State |
---|---|---|---|
Turkey | Gaziantep University | Gaziantep | Sehitkamil |
Lead Sponsor | Collaborator |
---|---|
University of Gaziantep |
Turkey,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Evaluation of Skeletal and Dental Changes in Millimetric Measurements | Skeletal and dental changes in the maxilla and mandible were evaluated in millimetres using lateral radiographs taken before and after treatment.
To determine skeletal changes A-VRP (mm), Co-A (mm), A-HRP (mm), Pog-VRP (mm), Co-Gn (mm) and WITS (mm) values were measured. To determine dental changes U1-VRP(mm), U1-HRP(mm), U6-VRP(mm), U6-HRP(mm), and L1-VRP(mm) values were measured. |
9 month | |
Secondary | Evaluation of Skeletal and Dental Changes in Angular Measurements | Skeletal and dental changes in the maxilla and mandible were evaluated in angularly using lateral radiographs taken before and after treatment.
To determine skeletal changes, the following angles were measured: SNA (°), SNB (°), ANB (°), SN-PP (°), SN-MP (°), PP-MP (°) and Ar-Go-Me (°). To determine dental changes, the following angles were measured: U1-SN (°) and IMPA (°). |
9 month |
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