Health Trials

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

ConditionsAngle Class I MaloclussionDental Crowding
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age16-32
SponsorUniversity of Baghdad

About this 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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

  • 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.

Treatment groups

42 Participants
are divided into 2 treatment groups
Group A: Self ligating bracket (Damon Ultima)Experimental treatment 1 intervention
Group B: Clear aligner systemExperimental treatment 1 intervention

Trial outcomes

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.

Time frame
From baseline (day of bonding/delivery) up to treatment completion (estimated 14 to 28 months).

Secondary outcomes

1

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."
2

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.
3

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
4

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Baghdad

Lead sponsor

Source ClinicalTrials.gov

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