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NCT07638397
Orthodontic Treatment Outcomes of Self Ligating System Compared to Clear Aligner System
Conditions: Angle Class I Maloclussion, Dental Crowding
Sex: All
Ages: 16 Years – 32 Years
Healthy volunteers: No
Phase: NA
Enrollment: 42
Sponsor: University of Baghdad
Location: University of Baghdad Baghdad Al-Rusafa
Summary
This study is a multi-center, prospective, parallel-group randomized controlled trial designed to compare the orthodontic treatment outcomes of a passive self-ligating bracket system (Damon Ultima) versus a clear aligner system. The primary objective is to evaluate and compare the total orthodontic treatment duration between the two systems in patients with Angle Class I malocclusion and moderate crowding. Secondary objectives include assessing alignment efficiency, patient pain perception at multiple time intervals, dental arch dimension changes, root volume loss percentage, and overall treatment quality using the American Board of Orthodontics Objective Grading System (ABO-OGS).
Eligibility Criteria
Inclusion Criteria:
1. Good oral and general health; no systemic conditions affecting bone metabolism or pain perception.
2. Age range between 16-32 years.
3. Presence of full permanent dentition except the third molars.
4. Class I canine and molar relationship moderate crowding in both arches (6-8 mm) requiring fixed orthodontic treatment.
5. Without previous orthodontic treatment/ functional appliances.
Exclusion Criteria:
1. Patients will be excluded from enrollment if they have a substantial skeletal discrepancy necessitating orthognathic surgery.
2. Patient with class Ⅱ , Ⅲ malocclusion.
3. Patient with external or internal root resorption.
4. Patients with poor oral hygiene or active periodontal disease.
5. 90o or more degree of tooth rotation.
Source: ClinicalTrials.gov (NCT07638397). StuddyBuddy aggregates publicly available trial information.