SmartArch vs Super Elastic NiTi Aligning Archwires

Crowding of Anterior Mandibular Teeth Clinical Trial

Official title:

The Effectiveness of SmartArch Versus Super Elastic Nickel-titanium Aligning Archwires: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05510206
• Other study ID #: 611422
• Status: Completed
• Phase: N/A
• Start date: April 17, 2022
• Est. completion date: December 14, 2022

Study information

• Verified date: May 2023
• Source: University of Baghdad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

This will be a multicenter non-stratified prospective randomized clinical trial with parallel groups trial with equal randomization (1:1 allocation ratio), two public orthodontic center 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. Then they will be provided by the patient information sheet and consent form, which explains the nature of the study, to read carefully at home and provide their decision about participation at the subsequent appointment. If the patient age below 18 years, parent assent should be taken. Any further enquiries regarding the study by the patient should be resolved by the investigator on the second visit.

The patients will be treated with straight wire appliance using MBT prescription brackets with 0.022-inch slot (Pinnacle®, Ortho Technology, USA). Bracket placement will be standardized using a height gauge. Initially, teeth polishing will be performed with pumice and rubber cup for 10 seconds using a low-speed handpiece, followed by water rinsing and air drying (oil-free air spray for 30 seconds). Bonding technique will be standardized as follows:

• Teeth etching with 37% phosphoric acid gel for 30 seconds.

• Rinsing thoroughly (5 seconds per tooth for liquid etchant and 10 seconds per tooth for gel etchant) to stop the etching process and to remove demineralized particles then air drying until the white frosty appearance of the etched surface is observed.

• Application of a thin layer of Light Bond™ Sealant (Reliance®, Itasca, USA) for one minute and air application for 5 seconds.

• Bonding of brackets and tubes using Light Bond™ light cure orthodontic adhesive (Reliance®, Itasca, USA) 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).

All the participants will receive a standardized treatment protocol. At the day of bonding, 0.016-inch archwire will be placed for the Smartarch group. It will be re-ligated every four weeks. While, for the super elastic NiTi group, 0.014-inch archwire will be placed at the day of bonding and eight weeks later it will be replaced by the 0.018-inch archwire for another eight weeks. Archwires will be tied to the bracket by elastomeric modules, with laceback of canines to first molars. If there is any debonding during treatment, this should be dealt with as an emergency case and re-bonded within 24 hours, otherwise the case will be considered as dropout. Since this study will be performed during the initial phase of treatment, no deviation in the protocol of treatment will be accepted (such as adding additional archwire in the sequence or using power chain). 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. Periapical X-ray for the mandibular central incisors will be taken pre-treatment and after 16 weeks. The participants will be provided by a visual analog scale (0-10) to record their pain perception during the first week after each wire placement.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 14, 2022
• Est. primary completion date: August 24, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Crowding of Anterior Mandibular Teeth

Intervention

Device:
• Leveling and alignment
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

Locations

Country	Name	City	State
Iraq	University of Baghdad\ College of Dentistry	Baghdad	Bab Al-Moadham

Sponsors (1)

Lead Sponsor	Collaborator
University of Baghdad

Country where clinical trial is conducted

Iraq, 

References & Publications (3)

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. — View Citation

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 Feb 3:cjz102. doi: 10.1093/ejo/cjz102. Online ahead of print. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Root resorption incidence using the scoring index that was provided by Malmgren et al. (1982)	assessed by scoring system for orthodontic induced apical root resorption from (0-3) on Root resorption will be evaluated for the mandibular central incisors using periapical radiographs with digital sensors, and the worst score for either left or right central will be taken using the scoring index by Malmgren et al. (1982): Grade 1: Irregular apical root contour. Grade 2: Minor apical root resorption, a small area of root loss amounting to less than 2 mm.; Grade 3: Severe apical root resorption from 2 mm to one third of the original root length.; Grade 4: Extreme apical root resorption exceeding one third of the original root length.	16 weeks
Secondary	Pain perception using visual analog scale	Evaluations of pain/discomfort will be made in the evening on a daily basis over the first seven days after bonding using a 10-point visual analog scale (VAS) with 0 refers to "no pain" and 10 refers to "intolerable pain". The participants will be reminded daily by a phone call or a text message to mark the recording sheet and will be asked to bring it on their next appointment.	1st week after wire placement