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| Name | Class |
|---|---|
| University of Baghdad | OTHER |
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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:
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 (Microfitâ„¢, 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:
Arch wire sequence for each group will be as follows:
I-arch system group (I-archâ„¢ Orthodontic System, SIA Orthodontic Manufacturer, Italy. (
• 0.016×0.014-inch copper nickel titanium.
MBT arch wire system group (Thermal NiTiâ„¢, SIA Orthodontic Manufacturer, Italy)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: I-arch system | Experimental | 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 | Intervention: Use of 0.014- then 0.016-inch heat-activated nickel titanium arch wire during the alignment stage. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| The amount of inclination of the incisors | Maxillary and mandibular incisors inclination will be measured on lateral cephalometric radiographs. | 16 weeks |
| The change in the width of dental arches |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Tabark H. Omran | Contact | B.D.S | +9647711387246 | tabarkhaleem9@gmail.com |
| Prof. dr. Yassir A. Yassir, PhD | Contact | +9647703919599 | yassirkyassir@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Yassir Yassir, PhD | College of dentistry/ Baghdad university | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AlHur ALriyahi and Hai Alhussein specialized dental centerS | Recruiting | Karbala | Iraq |
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.
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| 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. |
|
Maxillary and mandibular intermolar and intercanine widths will be measured on digital dental models.
| 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. | 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. | Throughout the seven days following the insertion of the first arch wire |
| ID | Term |
|---|---|
| D003441 | Crowding |
| ID | Term |
|---|---|
| D013037 | Spatial Behavior |
| D001519 | Behavior |
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