Clinical trial NCT05391542: Effectiveness of Tubular Coaxial Nickel-titanium and Copper Nickel-titanium Orthodontic Aligning Archwires
Official title: Effectiveness of Tubular Coaxial Nickel-titanium and Copper Nickel-titanium Orthodontic Aligning Archwires: A Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aligning Archwires
Lead sponsor: University of Baghdad
Sponsor class: OTHER
First posted: 2022-05-26
Enrollment: 33
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The patients will be treated with straight wire appliance using MBT prescription brackets with 0.022-inch slot (Pinnacle®, Ortho Technology, USA). Initially, teeth polishing will be performed with pumice and rubber cup, followed by water rinsing and air drying

Archwire sequence for each group will be as follows:

1. Coaxial tubular superelastic nickel-titanium Group (TuNT) (Speed tubular supercable, Speed System™ Orthodontics, Ontario, Canada):

   * 0.016-inch
   * 0.018-inch
2. Copper-nickel-titanium Group (CuNT) (Damon Optimal-Force Copper Ni-Ti®, Ormco, Glendora, Calif):

   * 0.014-inch
   * 0.018-inch Allocation Concealment: This will be achieved using sequentially numbered, opaque and sealed envelopes which will be numbered according to the study numbers. Each envelope includes the treatment allocation card (group 1 or 2) and the related archwires.
Primary purpose: TREATMENT

Brief summary: This study will be done to compare the effectiveness of using coaxial tubular superelastic nickel-titanium and copper-nickel-titanium archwires during the initial phase of orthodontic treatment regarding alignment efficiency, pain perception, and root resorption.

Detailed description: This will be a prospective blinded non-stratified randomized clinical trial , parallel group trial with equal randomization (1:1 allocation ratio), different private clinics and general hospitals will allocate patients for this trial. The patients will be initially assessed for eligibility to be included in the study by the investigator. Those who will meet the inclusion criteria will be informed about the nature of the study verbally to take the initial approval for participation. The patients were asked to read the patient information sheet carefully at home and inform the investigator about their decision of participation at the subsequent appointment and to sign consent form sheet in case of agreement.

The patients will be treated using MBT prescription brackets with 0.022-inch slot (Pinnacle®, Ortho Technology, USA). Initially, teeth polishing will be performed with pumice and rubber cup, followed by water rinsing and air drying

All the participants will receive the same treatment. At the day of bonding, the first archwire will be placed for each group. Eight weeks later it will be replaced by the next size archwire for another eight weeks. Archwires will be tied to the bracket using elastomeric ligatures. Any debonding during treatment should be considered an emergency and re-bonded within 24 hours, otherwise the case will be dropout. A good alginate impression for the lower arch should be taken pre-treatment and after 4, 8, 12 and 16 weeks and a stone study model is obtained. Periapical X-ray for the mandibular central incisors will be taken pre-treatment and after 16 weeks. The participants will be given visual analog scale to record their pain p during the first week after each archwire placement.

Eligibility criteria: Inclusion Criteria:

1. Patients indicated for fixed appliance orthodontic treatment with 5-9 mm crowding of mandibular anterior teeth according to Little's irregularity index (LII).
2. Presence of all the mandibular permanent teeth, except the third molars.
3. Overbite and overjet that do not interfere with bracket placement on mandibular anterior teeth.
4. No history of trauma or root resorption in the mandibular incisors.

Exclusion Criteria:

1. Previous orthodontic treatment.
2. Less than 5 mm of mandibular incisors crowding (LII).
3. Severe crowding which requires treatment by extraction of premolars in the mandibular arch.
4. Blocked-out teeth that cannot be engaged with the aligning archwire.
5. Prior experience of periodontal disease and loss of attachment.

Primary outcomes:
measure: Changes in alignment of anterior teeth will be measured using Little's irregularity index
timeFrame: 16 weeks
Secondary outcomes:
measure: Root resorption using the scoring index that was provided by Malmgren et al. (1982)
timeFrame: 16 weeks
measure: pain perception using visual analog scale
timeFrame: 1st week after each wire placement.
Other outcomes:
Locations:
city: Baghdad
country: Iraq
facility: Baghdad college of dentistry
Study officials:
affiliation: University of Baghdad
name: Yassir A. Yassir, M.Sc., P.hd. (UK)
role: STUDY_DIRECTOR
References:
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