Clinical Performance of the I-arch System During the Initial Stage of Orthodontic Treatment
NCT ID: NCT07264127
Last Updated: 2025-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2025-12-31
2026-09-30
Brief Summary
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* 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.
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Detailed Description
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Orthodontic treatment will be conducted using a straight wire appliance. MBT prescription brackets with 0.018-inch slot (Microfit™, SIA Orthodontic Manufacturer, Italy) will be used. With the aid of a height gauge, standardized bracket placement will be achieved. The technique will begin with a 10-second prophylactic procedure to clean and polish the teeth surfaces with pumice and a rubber cup using a slow-speed handpiece. Then, teeth will be rinsed with water and dried with oil-free air spray for 30 seconds. For the purpose of standardization, bonding procedure will be as followed:
* The enamel surface will be etched with 37% phosphoric acid gel for 30 seconds.
* The acid etchant will be rinsed off with water spray thoroughly.
* The tooth surface will be dried by air spray until the white frosty appearance of the etched surface is seen.
* A thin layer of Light Bond™ Sealant (Reliance®, Itasca, USA) will be applied on the etched enamel surface for one minute, then air will be applied for 5 seconds.
* Brackets and tubes will be bonded using Light Bond™ light cure orthodontic adhesive (Reliance®, Itasca, USA) which applied on their bases and light-cured above interproximal contacts at a distance of 2-3 mm (5 seconds mesially and 5 seconds distally for brackets and 10 seconds mesially and 10 seconds occlusally for molar tubes).
Arch wire sequence for each group will be as follows:
1. I-arch system group (I-arch™ Orthodontic System, SIA Orthodontic Manufacturer, Italy. (
• 0.016×0.014-inch copper nickel titanium.
2. MBT arch wire system group (Thermal NiTi™, SIA Orthodontic Manufacturer, Italy)
* 0.014-inch heat-activated nickel titanium.
* 0.016-inch heat-activated nickel titanium. A standardized protocol will be followed during the treatment for all the participants. At the day of bonding, 0.016×0.014 copper nickel titanium arch wire will be placed for the I-arch group and religated every four weeks. While, for the MBT group, 0.014-inch heat-activated nickel titanium arch wire will be placed at the day of bonding, then after 8 weeks it will be replaced by the 0.016-inch heat-activated nickel titanium arch wire for another 8 weeks (both will be religated every four weeks). Elastomeric modules will be used for ligating the wire to the brackets. If any bracket debonding occurs throughout the course of the treatment, it should be bonded again during 24 hours. Otherwise, the participant will be excluded from the trial. Since this study will be performed during the initial phase of treatment, no deviation from the protocol of treatment will be accepted (such as adding additional arch wire in the sequence or using power chain). Digital scan for the maxillary and mandibular arches will be taken pre-treatment and after 4, 8, 12 and 16 weeks, and a digital model will be obtained which will be used to measure Little's irregularity index, the intercanine and intermolar widths. Lateral cephalometric radiograph and periapical radiographs (for the maxillary and mandibular central incisors) will be taken pre-treatment and after 16 weeks. Lateral cephalometric radiographs will be used to measure the inclination of the maxillary and mandibular incisors. While the periapical radiographs will be used to assess the root resorption of the maxillary and mandibular central incisors. The participants will be supplied with a visual analog scale (0-10) to record their pain perception during the first seven days following the first wire placement. At the end of the trial, the treatment will continue as prescribed.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Arm 1: I-arch system
Intervention: Use of 0.016×0.014-inch copper nickel titanium arch wire during the alignment stage.
The use of 0.016×0.014 copper nickel titanium arch wire during the alignment stage.
Teeth alignment using an initial arch wire with a rectangular switched cross-section since the beginning of the treatment.
Arm 2: MBT arch wire system
Intervention: Use of 0.014- then 0.016-inch heat-activated nickel titanium arch wire during the alignment stage.
Use of 0.014- then 0.016-inch heat-activated nickel titanium arch wire during the alignment stage.
Teeth alignment using initial arch wires with round cross sections.
Interventions
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The use of 0.016×0.014 copper nickel titanium arch wire during the alignment stage.
Teeth alignment using an initial arch wire with a rectangular switched cross-section since the beginning of the treatment.
Use of 0.014- then 0.016-inch heat-activated nickel titanium arch wire during the alignment stage.
Teeth alignment using initial arch wires with round cross sections.
Eligibility Criteria
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Inclusion Criteria
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
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.
12 Years
ALL
No
Sponsors
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University of Baghdad
OTHER
Tabark H. Omran
OTHER
Responsible Party
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Tabark H. Omran
Principal investigator
Principal Investigators
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Yassir Yassir, PhD
Role: STUDY_DIRECTOR
College of dentistry/ Baghdad university
Central Contacts
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Other Identifiers
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ORTHO-UOB-2025
Identifier Type: -
Identifier Source: org_study_id
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