I-arch system for early-stage teeth alignment

I-arch in Action: Early Clinical Impact From a Randomized Controlled Trial

This study will test whether the I-arch wire helps people aged 12 and older with moderate front-tooth crowding get their teeth aligned faster, with less pain and less root damage.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 34 (estimated)
• Ages: 12 Years and up
• Sex: All
• Sponsor: University of Baghdad (Academic / other)
• Locations: 1 site (Karbala)
• Trial ID: NCT07264127 on ClinicalTrials.gov

What this trial studies

This multicenter, randomized, blinded, parallel-group trial will compare the I-arch system to a standard MBT arch-wire protocol during the initial alignment stage of orthodontic treatment. Patients with moderate mandibular anterior crowding (Little's irregularity index 3–6 mm), age 12 or older and with a full permanent dentition (excluding third molars), will be randomized 1:1 to receive either the I-arch (0.016×0.014 copper-nickel titanium) or a sequence of heat-activated NiTi wires (0.014 then 0.016) using MBT 0.018-inch slot brackets. Primary outcomes include rate of teeth alignment, changes in arch width and incisor inclination, patient-reported pain intensity, and radiographic root resorption, with standardized bonding and follow-up procedures across centers. Informed consent (and parental consent/assent for minors) will be obtained and patients will attend scheduled visits at participating orthodontic centers for treatment and assessments.

Who should consider this trial

Good fit: Ideal candidates are people age 12 or older with moderate mandibular anterior crowding (3–6 mm LII), full permanent dentition except third molars, no prior orthodontic treatment, and no periodontal disease or severely displaced teeth.

Not a fit: Patients with severe crowding (>6 mm), teeth that cannot be engaged by an aligning archwire, prior orthodontic treatment, periodontal compromise, or prior incisor trauma/root resorption are unlikely to benefit from this approach.

Why it matters

Potential benefit: If successful, the I-arch system could shorten the initial alignment phase and reduce pain and root resorption for patients with moderate crowding.

How similar studies have performed: Standard nickel-titanium and copper-nickel-titanium archwires have a strong evidence base for initial alignment, but published data specifically on the I-arch system are limited.

Eligibility criteria

Inclusion Criteria:

1. Moderate crowding of mandibular anterior teeth (3-6 mm) according to Little's irregularity index (LII) in patients with age of 12 years or older.
2. Full complement of permanent dentition should be present, except for the third molars.
3. Brackets should be placed on maxillary and mandibular anterior teeth without any interference by the existing overbite and overjet.
4. The maxillary and mandibular incisors should not be previously subjected to trauma or root resorption.

Exclusion Criteria:

1. Patients with history of previous orthodontic treatment.
2. Severe maxillary and mandibular anterior crowding which is greater than 6 mm (LII).
3. Presence of teeth that are severely misaligned out of the dental arch and cannot be engaged with the aligning arch wire.
4. Prescence of periodontally compromised teeth and previous loss of attachment.

Where this trial is running

Karbala

• AlHur ALriyahi and Hai Alhussein specialized dental centerS — Karbala, Iraq (Recruiting)

Study contacts

• Study coordinator: Tabark H. Omran

Conditions Effectiveness of the I-arch System; Archwire; Teeth alignment; Crowding; Orthodontics; Clinical trial; I-arch