Clinical Performance of the I-arch System During the Initial Stage of Orthodontic Treatment

NCT07264127 | Recruiting DMC

• 1 other identifier: ORTHO-UOB-2025
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this clinical trial is to learn if the I-arch system works to align the moderately misaligned teeth in patients seeking orthodontic treatment. it aims to answer the following questions:

• Does I-arch system increase the rate of teeth alignment?
• Does I-arch system produce significant changes in arch width and incisors inclination?
• Does I-arch system decrease the intensity of patient-reported pain and root resorption? Researchers will compare the effectiveness of the I-arch and MBT arch wire system.

Conditions

Effectiveness of the I-arch System

Keywords

Archwire; Teeth alignment; Crowding; Orthodontics; Clinical trial; I-arch

Outcome Measures

Primary Outcomes (1)

• The rate of alignment

  Alignment rate will be measured using Little's Irregularity Index on digital dental models. This index range between 0 to 10. "0" indicates perfect alignment, while "10" indicates very severe irregularities.

  16 weeks

Secondary Outcomes (4)

• The amount of inclination of the incisors

  16 weeks

• The change in the width of dental arches

  16 weeks

• The amount of root resorption

  16 weeks

• The intensity of pain

  Throughout the seven days following the insertion of the first arch wire

Study Arms (2)

Arm 1: I-arch system

EXPERIMENTAL

Intervention: Use of 0.016×0.014-inch copper nickel titanium arch wire during the alignment stage.

Device: The use of 0.016×0.014 copper nickel titanium arch wire during the alignment stage.

Arm 2: MBT arch wire system

ACTIVE COMPARATOR

Intervention: Use of 0.014- then 0.016-inch heat-activated nickel titanium arch wire during the alignment stage.

Device: Use of 0.014- then 0.016-inch heat-activated nickel titanium arch wire during the alignment stage.

Interventions

Use of 0.014- then 0.016-inch heat-activated nickel titanium arch wire during the alignment stage. DEVICE

Teeth alignment using initial arch wires with round cross sections.

Arm 2: MBT arch wire system

The use of 0.016×0.014 copper nickel titanium arch wire during the alignment stage. DEVICE

Teeth alignment using an initial arch wire with a rectangular switched cross-section since the beginning of the treatment.

Arm 1: I-arch system

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Full complement of permanent dentition should be present, except for the third molars.
• Brackets should be placed on maxillary and mandibular anterior teeth without any interference by the existing overbite and overjet.
• The maxillary and mandibular incisors should not be previously subjected to trauma or root resorption.

You may not qualify if:

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

Sponsors & Collaborators

• Tabark H. Omran: lead
• University of Baghdad: collaborator

Study Sites (1)

AlHur ALriyahi and Hai Alhussein specialized dental centerS

Karbala, Iraq

RECRUITING

MeSH Terms

Conditions

Crowding

Condition Hierarchy (Ancestors)

Spatial Behavior; Behavior

Study Officials

• Yassir Yassir, PhD

  College of dentistry/ Baghdad university

  STUDY DIRECTOR

Central Study Contacts

Tabark H. Omran

CONTACT

B.D.S; tabarkhaleem9@gmail.com

Prof. dr. Yassir A. Yassir, PhD

CONTACT

yassirkyassir@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 23, 2025
• First Posted: December 4, 2025
• Study Start: December 1, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IR (1)