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A Clinical Comparison of the Effectiveness of Two Types of Orthodontic Aligning Archwire Materials

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ClinicalTrials.gov Identifier: NCT04090931
Recruitment Status : Completed
First Posted : September 16, 2019
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Yassir A. Yassir, University of Baghdad

Brief Summary:

The aim of this study is to compare the effectiveness of using heat-activated NiTi with superelastic NiTi archwires during the initial phase of orthodontic treatment.

Primary Objective:

To compare the difference in the amount of crowding in the lower incisors after 4 and 8 weeks from the start of treatment.

Secondary Objectives:

  1. To compare the amount of orthodontically-induced inflammatory root resorption (OIIRR) in the apical region of mandibular central incisors between the two groups of archwires
  2. To compare the amount of pain perception between the two groups of archwires during the 1st week after each wire placement.

Condition or disease Intervention/treatment Phase
Teeth; Anomaly, Position Procedure: Orthodontic treatment Not Applicable

Detailed Description:

Objectives: To compare the heat-activated nickel titanium (HANT) with superelastic nickel titanium (SENT) archwires in terms of their effectiveness in aligning teeth, possibility of inducing root resorption, and patient perception of pain during the initial phase of treatment.

Subjects and Methods: Orthodontic patient aged 12 years or over with lower anterior crowding of 3-6 mm. who need treatment without extraction, were randomly allocated to the HANT and SENT archwires groups with a 1:1 allocation ratio. Archwire sequence in both groups was 0.014-inch and 0.016-inch, respectively. Each archwire was placed for 4 weeks. Outcome measures included the amount of crowding using Little's irregularity index (LII), apical root resorption, and pain perception. The effectiveness of alignment was tested using 2X2 mixed factorial ANOVA, while root resorption and pain perception were tested by the Mann-Whitney U test, and Wilcoxon signed-rank test (P<0.05).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 31 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Orthodontic patients
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Blinding to treatment allocation was possible only for the investigator and data analyst because the clinicians could know the type of archwiers from their flexibility. All the trial documents were labeled with the study ID number, which was used for participant identification and data collection without unmasking the allocation group. This allowed the investigator to complete data collection and measurements blindly.
Primary Purpose: Treatment
Official Title: A Clinical Comparison of the Effectiveness of Two Types of Orthodontic Aligning Archwire Materials: A Randomized Clinical Trial
Actual Study Start Date : January 3, 2019
Actual Primary Completion Date : April 26, 2019
Actual Study Completion Date : September 9, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Orthodontia
Drug Information available for: Nickel

Arm Intervention/treatment
Experimental: Heat-Activated Nickel-Titanium Archwires

Heat-activated NiTi (HANT) Group (TruFlex™ Thermal Nickel-Titanium, Ortho Technology, USA):

  • 0.014-inch HANT
  • 0.016-inch HANT
Procedure: Orthodontic treatment
leveling and aligning stage in orthodontics

Experimental: Superelastic Nickel-Titanium Archwires

Superelastic NiTi (SENT) Group (TruFlex™ Nickel-Titanium, Ortho Technology, USA):

  • 0.014-inch SENT
  • 0.016-inch SENT
Procedure: Orthodontic treatment
leveling and aligning stage in orthodontics




Primary Outcome Measures :
  1. Primary outcome (Alignment efficiency) [ Time Frame: 2 months ]
    The study models, which should be free from any inconsistency (such as bubbles), were used to measure the Little's irregularity index (Little, 1975). This was calculated using a digital Vernier caliper to measure the extent of mesial and distal contact displacement from the mesial contact point of lower canine to that on the other side (to the nearest 0.01mm).


Secondary Outcome Measures :
  1. Root resorption [ Time Frame: 2 months ]
    Root resorption was evaluated pre-treatment and after 8 weeks using periapical X-ray with digital X-ray sensors (ATECO). Radiographic films were positioned using a customized sensor holder for the lower anterior teeth with a 7cm film-cone distance using long cone paralleling technique. The radiographs were made at 70kV and 8mA DC with an exposure of 0.25 seconds.

  2. Pain perception [ Time Frame: 2 months ]
    Evaluations of pain/discomfort was made in the evening on a daily basis over the first 7 days after bonding using a 10-point visual analog scale (VAS) of 10cm length. The highest pain level experienced should be reported by each patient. The recording sheet was received by all the patients on the day of bonding, it included seven visual analog scales (one for each day) and the patients were given oral instructions on how to finish the VAS by marking the point on the line which supposed to represent the maximum pain that they felt per day, with 0 refers to "no pain" and 10 refers to "intolerable pain". Patients were reminded daily by a phone call or a text message to mark the recording sheet and to bring it on their next appointment.



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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Patients indicated for fixed appliance orthodontic treatment who have a moderate crowding (3-6mm) according to the Little's irregularity index (LII).
  2. Full set of lower permanent dentition excluding the third molars.
  3. No history of trauma or root resorption in the lower incisors.

Exclusion Criteria:

  1. Previous orthodontic treatment.
  2. Less than 3mm of lower incisor crowding (LII) or with spaced incisors.
  3. Severe crowding in the lower arch (greater than 7mm) which requires extraction.
  4. Blocked-out teeth that cannot be engaged with the aligning archwire.
  5. Patients with periodontally compromised teeth.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090931


Locations
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Iraq
Yassir A. Yassir
Baghdad, Iraq, 00964
Sponsors and Collaborators
University of Baghdad

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Responsible Party: Yassir A. Yassir, Assistant Professor of Orthodontics, University of Baghdad
ClinicalTrials.gov Identifier: NCT04090931     History of Changes
Other Study ID Numbers: University of Baghdad
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Materials, Methods, Results

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tooth Abnormalities
Congenital Abnormalities
Stomatognathic System Abnormalities
Stomatognathic Diseases
Tooth Diseases
Nickel
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs