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

NCT07638397 | Not Yet Recruiting

• 1 other identifier: 1193426
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Angle Class I Maloclussion; Dental Crowding

Keywords

Damon ultima; clear aligner

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Patient Pain Perception.

  "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

  Baseline (Day 1) and at the completion of the leveling and alignment phase, up to 6 months.

• Changes in Dental Arch Dimensions

  Baseline (Day 1) and through study completion, an average of 14 months

• Root Volume Loss Percentage.

  Baseline (Day 1) and through study completion, an average of 14 months

• Objective Grading System Score.

  Through study completion, an average of 14 months

Study Arms (2)

Self ligating bracket (Damon Ultima)

EXPERIMENTAL

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

Clear aligner system

EXPERIMENTAL

Patient will be treated with thermoformed Clear aligner until dental levelling alignment , crowding resolved and case will be finished

Device: Clear aligner

Interventions

self ligating bracket DEVICE

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.

Self ligating bracket (Damon Ultima)

Clear aligner DEVICE

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.

Clear aligner system

Eligibility Criteria

• Age: 16 Years - 32 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Good oral and general health; no systemic conditions affecting bone metabolism or pain perception.
• Age range between 16-32 years.
• Presence of full permanent dentition except the third molars.
• Class I canine and molar relationship moderate crowding in both arches (6-8 mm) requiring fixed orthodontic treatment.
• Without previous orthodontic treatment/ functional appliances.

You may not qualify if:

• Patients will be excluded from enrollment if they have a substantial skeletal discrepancy necessitating orthognathic surgery.
• Patient with class Ⅱ , Ⅲ malocclusion.
• Patient with external or internal root resorption.
• Patients with poor oral hygiene or active periodontal disease.
• o or more degree of tooth rotation.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

University of Baghdad

Baghdad, Al-Rusafa, 0964, Iraq

Location

MeSH Terms

Conditions

Crowding

Interventions

Orthodontic Appliances, Removable

Condition Hierarchy (Ancestors)

Spatial Behavior; Behavior

Intervention Hierarchy (Ancestors)

Orthodontic Appliances; Orthodontics; Dentistry

Study Officials

• Mohanad Ali Mohammed

  University of Baghdad

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mohanad Ali Mohammed

CONTACT

+9647702797532; Mohannad.ali1203a@codntal.uobaghda.edu.iq

Harraa Sabbah Abul ameer

CONTACT

+9647904546371; dr.haraa_sabah@codental.uobaghdad.edu.iq

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dentist, M.S.C in orthodontics .. PHD student

Study Record Dates

• First Submitted: April 27, 2026
• First Posted: June 10, 2026
• Study Start: May 15, 2026
• Primary Completion (Estimated): November 20, 2027
• Study Completion (Estimated): August 20, 2028
• Last Updated: June 10, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)