An interventional study of self ligating bracket and Clear aligner in Angle Class I Maloclussion and Dental Crowding, sponsored by University of Baghdad. Not yet recruiting at 1 site in Iraq. Open to participants aged 16 Years to 32 Years. Per ClinicalTrials.gov, last updated 2026-07-07.
Sponsored by University of Baghdad · Not applicable, Interventional, and Treatment
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).
Participants aged 17-32 years with full permanent dentition, Class I canine and molar relationships, and moderate crowding (4-8 mm) will be randomly assigned in a 1:1 ratio to either the Damon Ultima group or the Clear Aligner group.
For the Damon Ultima group, brackets will be bonded according to a standardized protocol, utilizing a precise archwire sequence from 0.014-inch CuNiTi up to 0.019x0.0275-inch stainless steel wires. For the Clear Aligner group, patients will be treated with a series of thermoformed removable aligners designed via digital software, with instructions to wear them for 22 hours per day, changing aligners every 2 weeks.
Outcome measurements will include total treatment duration in months, pain perception via a 10-cm Visual Analog Scale (VAS), dental arch changes on 3D digital models, and root resorption via Cone-Beam Computed Tomography (CBCT) radiographs.
88 studies on the registry are indexed under Crowding; 22 are open to participants now.
This study's planned enrollment of 42 is above the median of 36 across 74 interventional studies indexed under Crowding.
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Exclusion Criteria:
Patient will be treated with self ligating bracket (Damon Ultima) until dental levelling alignment , crowding resolved and case will be finished
Device: self ligating bracket
Patient will be treated with thermoformed Clear aligner until dental levelling alignment , crowding resolved and case will be finished
Device: Clear aligner
Teeth will be bonded with Damon Ultima® bracket system by the same protocol of bonding for all patients with the same bonding materials, time and curing apparatus by highly filled light-cure adhesive (Enlight, Ormco Corp., Glendora, California, USA). Archwire sequence will be: 0.014-inch CuNiTi, 0.018-inch CuNiTi, 0.014×0.0275-inch CuNiTi, 0.018×0.0275-inch CuNiTi archwires and 0.019×0.0275-inch stainless steel Ultima finishing archwires if needed. Appointment intervals will be 6-8 weeks for treatment mechanics, including use of inter-arch elastics, bite raiser, and finishing procedures will be standardized. All patients will receive oral hygiene instructions at each visit. In case of bracket failure, brackets will be rebonded using the same system within 24 hours, otherwise the case would be considered as dropout.
a series of invisible thermoformed removable aligners after designed by software and delivered to patients after the digital scanning of the initial models. A series of nearly invisible appliances to incrementally move the teeth from their crowded initial position to their final straightened position, these subjects will instructed to wear each aligner 22 hours a day, 7 days a week . The anterior teeth will be reduce at each interproximal location by means of diamond-coated finishing strips used for interproximal reduction , in case of debond attachment should be bonded within 24 hours.
Primary Objectives : Total Treatment Duration.
The total time required to complete the orthodontic treatment from the day of appliance bonding/delivery to the day of debonding/treatment completion.
Time frame: From baseline (day of bonding/delivery) up to treatment completion (estimated 14 to 28 months).
Patient Pain Perception.
Changes in pain levels scored by patients using a Visual Analog Scale (VAS), where 0 indicates "no pain" and 10 indicates "severe, unbearable pain". Units on a scale (0-10).
Time frame: "Baseline (Day 1), and at 6 hours, 24 hours, 3 days, and 7 days following the initial appliance insertion and after each subsequent archwire activation or aligner change throughout the active treatment phase, up to 14 months."
Dental Arch Alignment Efficiency
Assessment of dental crowding reduction measured on 3D digital models using Little's Irregularity Index (LII) Unit of Measure: Millimeters (mm).
Time frame: Baseline (Day 1) and at the completion of the leveling and alignment phase, up to 6 months.
Changes in Dental Arch Dimensions
Measurement of dental arch length, arch perimeter, and transverse widths (inter-canine, inter-premolar, and inter-molar widths) on 3D digital models. Unit of Measure: Millimeters (mm).
Time frame: Baseline (Day 1) and through study completion, an average of 14 months
Root Volume Loss Percentage.
Evaluation of external apical root resorption and volume loss percentage of the teeth calculated via Cone-Beam Computed Tomography (CBCT). Unit of Measure: Percentage (%).
Time frame: Baseline (Day 1) and through study completion, an average of 14 months
Objective Grading System Score.
Evaluation of the final orthodontic treatment outcome quality using the American Board of Orthodontics Objective Grading System (ABO-OGS) on digital models. Unit of Measure: Points/Score.
Time frame: Through study completion, an average of 14 months
Plan to share: No
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