SmartArch vs Super Elastic NiTi Aligning Archwires

NCT05510206 | Completed

• 1 other identifier: 611422
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This study is intended primarily to compare the alignment efficiency and rate of two different types of archwires that are used in the first stage of orthodontic treatment , also addressing pain and root resorption that may be associated during treatment, with the hypothesis being a consideration of no deference between the two archwires.

Conditions

Crowding of Anterior Mandibular Teeth

Keywords

lower anterior crowding

Outcome Measures

Primary Outcomes (1)

• Changes in alignment of anterior teeth will be measured using Little's irregularity index

  A good-quality 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. This study model which should be free from any discrepancy (such as bubbles) will be used to measure Little's irregularity index using a digital Vernier caliper to calculate the amount of mesial and distal contact displacement from the mesial contact surface of right mandibular canine to that on the other side, to the nearest 0.01 mm. The sum of these measurements represents the amount of Little's irregularity index.

  16 weeks

Secondary Outcomes (2)

• Root resorption incidence using the scoring index that was provided by Malmgren et al. (1982)

  16 weeks

• Pain perception using visual analog scale

  1st week after wire placement

Study Arms (2)

Super elastic NiTi Group

ACTIVE COMPARATOR

0.014-inch super elastic nickel-titanium archwire (ortho Technology™ , west Columbia, USA) will be placed in mandibular arch at the day of bonding. Eight weeks later it will be replaced by the 0.018-inch archwire for another eight weeks.

Device: Leveling and alignment

Smartarch Group

EXPERIMENTAL

0.016-inch Smartarch archwir (Ormco™, USA) will be placed in mandibular arch at the day of bonding. Re-ligated every four weeks for 16 weeks.

Device: Leveling and alignment

Interventions

Leveling and alignment DEVICE

Polishing, Bonding of appliance, placement of the first arch wire for Super elastic NiTi group then the second wire after two months taking study model each month during the study For Smartarch Group placing experimental arch wire for 4 months , taking impression each month. For both groups peri-apical X-Ray to lower anterior teeth is taken prior to treatment and 4 months later, also visual pain analogue scale is taken for 7 days after placing archwires

Smartarch Group; Super elastic NiTi Group

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:

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

You may not qualify if:

• Previous orthodontic treatment.
• Less than 5mm of mandibular incisor crowding (LII).
• Blocked-out teeth that cannot be engaged with the aligning archwire.
• Prior experience of periodontal disease and loss of attachment.

Sponsors & Collaborators

• University of Baghdad: lead

Study Sites (1)

University of Baghdad\ College of Dentistry

Baghdad, Bab Al-Moadham, 10047, Iraq

Location

Related Publications (4)

• Malmgren O, Goldson L, Hill C, Orwin A, Petrini L, Lundberg M. Root resorption after orthodontic treatment of traumatized teeth. Am J Orthod. 1982 Dec;82(6):487-91. doi: 10.1016/0002-9416(82)90317-7.

  PMID: 6961819 BACKGROUND

• Nabbat SA, Yassir YA. A clinical comparison of the effectiveness of two types of orthodontic aligning archwire materials: a multicentre randomized clinical trial. Eur J Orthod. 2020 Dec 2;42(6):626-634. doi: 10.1093/ejo/cjz102.

  PMID: 32011678 BACKGROUND

• Wang Y, Liu C, Jian F, McIntyre GT, Millett DT, Hickman J, Lai W. Initial arch wires used in orthodontic treatment with fixed appliances. Cochrane Database Syst Rev. 2018 Jul 31;7(7):CD007859. doi: 10.1002/14651858.CD007859.pub4.

  PMID: 30064155 BACKGROUND

• Noori RM, Ahmed OK, Kadhum AS, Yassir YA, Di Blasio M, Russo D, Cicciu M, Minervini G. The Effectiveness of Conventional and Advanced Aligning Archwires: The Insights of Two Randomized Clinical Trials. Eur J Dent. 2025 Oct;19(4):985-997. doi: 10.1055/s-0044-1795080. Epub 2025 Apr 4.

  PMID: 40185146 DERIVED

Study Officials

• Ammar S. Kadhum, Asst. Prof.

  University of Baghdad

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthodontics master student

Study Record Dates

• First Submitted: August 2, 2022
• First Posted: August 22, 2022
• Study Start: April 17, 2022
• Primary Completion: August 24, 2022
• Study Completion: December 14, 2022
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will share

Locations

IR (1)