Effectiveness of the I-arch SystemNCT07264127
Clinical Performance of the I-arch System During the Initial Stage of Orthodontic Treatment
A study testing The use of 0.016×0.014 copper nickel titanium arch wire during the alignment stage. and Use of 0.014- then 0.016-inch heat-activated nickel titanium arch wire during the alignment stage. in people with Effectiveness of the I-arch System, run by Tabark H. Omran at 1 site in Iraq.
Trial 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… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Effectiveness of the I-arch System
- What is being tested?
- The use of 0.016×0.014 copper nickel titanium arch wire during the alignment stage. and Use of 0.014- then 0.016-inch heat-activated nickel titanium arch wire during the alignment stage.
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteIraq
- Study dates
- 1 Dec 2025to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Prof. dr. Yassir A. Yassir, PhD contact
Iraq1 site, 1 recruiting
- Recruiting
AlHur ALriyahi and Hai Alhussein specialized dental centerS
Karbala
Tabark Omran, postgraduate student
About this study
Official title: I-arch in Action: Early Clinical Impact From a Randomized Controlled Trial
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.
Read the detailed description
This study will be a multicenter non-stratified prospective randomized clinical trial designed as a blinded, parallel group trial with equal randomization (1:1 allocation ratio). It will be conducted at multiple orthodontic centers. Initially, the eligibility of the patients to participate in this study will be evaluated by the investigator. Verbal information about the nature of study will be supplied for those who will satisfy the inclusion criteria to obtain their preliminary approval. Then the patient information sheet and consent form will be given to the patients to read carefully at home to decide whether they will participate in the study at the following visit. Patient assent/parental consent will be taken for participants below 18 years. If the patients have any queries regarding the study, the investigator should resolve it on the following visit.
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:
- I-arch system group (I-arch™ Orthodontic System, SIA Orthodontic Manufacturer, Italy. (
- 0.016×0.014-inch copper nickel titanium.
- 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
- Effectiveness of the I-arch System
- Being tested
- The use of 0.016×0.014 copper 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.
- Keywords
- Archwire, Teeth alignment, Crowding, Orthodontics, Clinical trial, I-arch
- Medical subject headings
- Crowding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1: I-arch system | Experimental | Intervention: Use of 0.016×0.014-inch copper nickel titanium arch wire during the alignment stage. Receives: 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. Receives: Device: Use of 0.014- then 0.016-inch heat-activated nickel titanium arch wire during the alignment stage. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 16 weeks
Secondary outcomes (4)
The amount of inclination of the incisors
Maxillary and mandibular incisors inclination will be measured on lateral cephalometric radiographs.
Measured: 16 weeks
The change in the width of dental arches
Maxillary and mandibular intermolar and intercanine widths will be measured on digital dental models.
Measured: 16 weeks
The amount of root resorption
the root resorption of the maxillary and mandibular central incisors will be assessed on periapical radiographs using the long cone paralleling technique. The root resorption will be measured according to Malmgren Index. this index range between 0 to 4. "0" indicates no resorption, while "4" indicates the resorption of more than one-third of the root length.
Measured: 16 weeks
The intensity of pain
Pain intensity will be measured using visual analog scale. The minimum value is zero, while the maximum one is 10. The highest pain intensity is reported as 10.
Measured: Throughout the seven days following the insertion of the first arch wire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start1 Dec 2025
- Primary completion1 Jul 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Effectiveness of the I-arch SystemStudies 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
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tabark H. Omran
- Sponsor type
- University, hospital or other
- Collaborators
- University of Baghdad
- Responsible party
- Sponsor-investigator, Tabark H. Omran, University of Baghdad
- Investigators
- Yassir Yassir, PhD, Study director, College of dentistry/ Baghdad university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07264127
- Sponsor's protocol ID
- ORTHO-UOB-2025
- Status last verified
- Apr 2026
- First submitted
- 23 Nov 2025
- Last updated
- 22 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: For the purpose of maintaining the confidentiality of the participants and the associated restrictions imposed by the ethics committee, we choose not to share IPD. However, IPD can be shared with journal editor upon request during the study publication.
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- I-arch in Action: Early Clinical Impact From a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07264127
- Acronym / sponsor ID
- ORTHO-UOB-2025
- Conditions
- Effectiveness of the I-arch System
- Keywords
- Archwire, Teeth alignment, Crowding, Orthodontics, Clinical trial, I-arch
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Tabark H. OmranUniversity, hospital or other
- Collaborators
- University of Baghdad
- Study start
- 1 Dec 2025 (actual)
- Primary completion
- 1 Jul 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will be a multicenter non-stratified prospective randomized clinical trial designed as a blinded, parallel group trial with equal randomization (1:1 allocation ratio). It will be conducted at multiple orthodontic centers. Initially, the eligibility of the patients to participate in this study will be evaluated by the investigator. Verbal information about the nature of study will be supplied for those who will satisfy the inclusion criteria to obtain their preliminary approval. Then the patient information sheet and consent form will be given to the patients to read carefully at home to decide whether they will participate in the study at the following visit. Patient assent/parental consent will be taken for participants below 18 years. If the patients have any queries regarding the study, the investigator should resolve it on the following visit.
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:
- I-arch system group (I-arch™ Orthodontic System, SIA Orthodontic Manufacturer, Italy. (
- 0.016×0.014-inch copper nickel titanium.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: I-arch system | Experimental | Device: The use of 0.016×0.014 copper nickel titanium arch wire during the alignment stage.Intervention: Use of 0.016×0.014-inch copper nickel titanium arch wire during the alignment stage. |
| Arm 2: MBT arch wire system | Active comparator | Device: Use of 0.014- then 0.016-inch heat-activated nickel titanium arch wire during the alignment stage.Intervention: Use of 0.014- then 0.016-inch heat-activated nickel titanium arch wire during the alignment stage. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Arm 1: I-arch system |
| 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. | Device | Arm 2: MBT arch wire system |
Primary outcome
The rate of alignment
Time frame: 16 weeks
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.
4 secondary outcomes
The amount of inclination of the incisors
Time frame: 16 weeks
The change in the width of dental arches
Time frame: 16 weeks
The amount of root resorption
Time frame: 16 weeks
The intensity of pain
Time frame: Throughout the seven days following the insertion of the first arch wire
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2026.
- Individual participant dataSharing planned: No. For the purpose of maintaining the confidentiality of the participants and the associated restrictions imposed by the ethics committee, we choose not to share IPD. However, IPD can be shared with journal editor upon request during the study publication.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Prof. dr. Yassir A. Yassir, PhD contact
Yassir Yassir, PhD study director
College of dentistry/ Baghdad university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing The use of 0.016×0.014 copper nickel titanium arch wire during the alignment stage. and Use of 0.014- then 0.016-inch heat-activated nickel titanium arch wire during the alignment stage. in people with Effectiveness of the I-arch System, run by Tabark H. Omran at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Tabark H. Omran (B.D.S ext. +9647711387246, tabarkhaleem9@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The rate of alignment (time frame: 16 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2026.