Orthodontic Treatment Outcomes of Self Ligating System Compared to Clear Aligner System

Orthodontic Treatment Outcomes of Self Ligating System Compared to Clear Aligner System : A Randomized Clinical Trial

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).

Study Overview

• Status: Not yet recruiting
• Conditions: Dental Crowding; Angle Class I Maloclussion
• Intervention / Treatment: Device: self ligating bracket; Device: Clear aligner

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 42
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mohanad Ali Mohammed; Phone Number: +9647702797532; Email: Mohannad.ali1203a@codntal.uobaghda.edu.iq
• Study Contact Backup: Name: Harraa Sabbah Abul ameer; Phone Number: +9647904546371; Email: dr.haraa_sabah@codental.uobaghdad.edu.iq

Study Locations

• Iraq
  • Al-Rusafa
    • Baghdad, Al-Rusafa, Iraq, 0964
      • University of Baghdad

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Self ligating bracket (Damon Ultima); 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; 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.
Experimental: Clear aligner system; Patient will be treated with thermoformed Clear aligner until dental levelling alignment , crowding resolved and case will be finished	Device: Clear aligner; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	From baseline (day of bonding/delivery) up to treatment completion (estimated 14 to 28 months).

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	"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).	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).	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 (%).	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.	Through study completion, an average of 14 months

Collaborators and Investigators

• Sponsor: University of Baghdad
• Investigators: Principal Investigator: Mohanad Ali Mohammed, University of Baghdad

Study record dates

Study Major Dates

• Study Start (Estimated): May 15, 2026
• Primary Completion (Estimated): November 20, 2027
• Study Completion (Estimated): August 20, 2028

Study Registration Dates

• First Submitted: April 27, 2026
• First Submitted That Met QC Criteria: June 4, 2026
• First Posted (Actual): June 10, 2026

Study Record Updates

• Last Update Posted (Actual): June 10, 2026
• Last Update Submitted That Met QC Criteria: June 4, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: clear aligner; Damon ultima
• Additional Relevant MeSH Terms: Behavior; Spatial Behavior; Crowding; Dentistry; Orthodontic Appliances; Orthodontics; Orthodontic Appliances, Removable
• Other Study ID Numbers: 1193426

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No