Angle Class I MaloclussionNCT07638397
Orthodontic Treatment Outcomes of Self Ligating System Compared to Clear Aligner System
A study testing self ligating bracket and Clear aligner in people with Angle Class I Maloclussion and Dental Crowding, run by University of Baghdad at 1 site in Iraq.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 32 years
- Conditions the study is for
- Angle Class I Maloclussion, Dental Crowding
- What is being tested?
- self ligating bracket and Clear aligner
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteIraq
- Study dates
- 15 Sep 2026to 20 Aug 2028
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 32 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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.
- 90o or more degree of tooth rotation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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).
Read the 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.
- Conditions
- Angle Class I Maloclussion, Dental Crowding
- Being tested
- self ligating bracket, Clear aligner
- Keywords
- Damon ultima, clear aligner
- Medical subject headings
- Crowding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
self ligating bracketDevice
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 alignerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Device: Clear aligner |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline (day of bonding/delivery) up to treatment completion (estimated 14 to 28 months).
Secondary outcomes (5)
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).
Measured: "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).
Measured: 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).
Measured: 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 (%).
Measured: 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.
Measured: Through study completion, an average of 14 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2026
- Study start15 Sep 2026 (estimated)
- Primary completion20 Nov 2027 (estimated)
- Study completion20 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Angle Class I MaloclussionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 42 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohanad Ali Mohammed, University of Baghdad
- Investigators
- Mohanad Ali Mohammed, Principal investigator, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07638397
- Sponsor's protocol ID
- 1193426
- Status last verified
- Jul 2026
- First submitted
- 27 Apr 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No