Alignment Efficiency of Two Thermal Activated Orthodontic Archwire Sequences

Alignment Efficiency of Two Thermal Activated Orthodontic Archwire Sequences Based on Transition Temperature Range: A Randomized Clinical Trial

The aim of the present study was to compare the effectiveness of two alignment sequences with thermal activated archwires with different Af temperatures applied for the correction of mandibular anterior crowding

Study Overview

• Status: Completed
• Conditions: Crowding
• Intervention / Treatment: Device: Fixed orthodontics appliance and arch wire

Detailed Description

A parallel randomized clinical trial was conducted involving 42 patients ages 15 to 25 years (mean: 19.5 years) who required orthodontic treatment including the correction of mandibular anterior crowding. Eligibility criteria were no active caries, exemplary hygiene, non- extraction in the lower arch and no significant tooth size or shape abnormalities. Outcome: The primary outcome was the degree of crowding measured on plaster casts using Little's Irregularity Index. The secondary outcome was crowding survival time until the occurrence of correction in a six-month period. Randomization: The patients were randomly allocated to the different groups using sealed opaque envelopes. Blinding: The patients were blinded to the group to which they were allocated. Intervention: Patients were treatment with a pre-adjusted appliance (0.022 in- Roth prescription). Two nickel-titanium alignment and leveling sequences were employed - NiTi archwire: 0.012 in and 0.019 X 0.025 in; and thermal activated NiTi archwires: 0.018 in and 0.016 X 0.022 in with different austenite finish temperatures (37ºC and 35ºC), which formed the different study groups.

• Study Type: Interventional
• Enrollment (Actual): 44
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 25 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Moderate mandibular anterior crowding (crowding: 4 to 6 mm) according to Little's Irregularity Index
• Presence of all teeth in lower arch through to the second molars, no indication for extractions in the lower arch
• No need for therapeutic interventions (use of inter-maxillary elastic bands, inter-dental wear, open NiTi spine, active lip bumper)
• Absence of systemic conditions that could affect tooth movements
• Absence of significant tooth size or shape abnormalities
• No history of trauma and no history of root resorption or alveolar bone loss.

Exclusion Criteria:

• Severe mandibular anterior crowding (crowding: up to 7 mm) according to Little's Irregularity Index
• Absence of any teeth in lower arch through to the second molars
• Indication for extractions in the lower arch
• Need for therapeutic interventions (use of inter-maxillary elastic bands, inter-dental wear, open NiTi spine, active lip bumper)
• Presence of systemic conditions that could affect tooth movements
• Presence of significant tooth size or shape abnormalities
• History of trauma and history of root resorption or alveolar bone loss.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NiTi Af 37ºC; Patients were treatment with fixed orthodontics appliance and arch wire. Two nickel-titanium alignment and leveling sequences were employed - NiTi archwire: 0.012 in and 0.019 X 0.025 in; and thermal activated NiTi archwires: 0.018 in and 0.016 X 0.022 in with different austenite finish temperatures (37ºC).	Device: Fixed orthodontics appliance and arch wire; Two nickel-titanium alignment and leveling sequences were employed; Other Names: the alignment of mandibular anterior crowding
Experimental: NiTi Af 35ºC; Patients were treatment fixed orthodontics appliance and arch wire. Two nickel-titanium alignment and leveling sequences were employed - NiTi archwire: 0.012 in and 0.019 X 0.025 in; and thermal activated NiTi archwires: 0.018 in and 0.016 X 0.022 in with different austenite finish temperatures (35ºC)	Device: Fixed orthodontics appliance and arch wire; Two nickel-titanium alignment and leveling sequences were employed; Other Names: the alignment of mandibular anterior crowding

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Degree of crowding measured on plaster casts using Little's Irregularity Index	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
crowding survival time	six months

Collaborators and Investigators

• Sponsor: Faculty Sao Leopoldo Mandic Campinas

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: April 9, 2015
• First Submitted That Met QC Criteria: April 13, 2015
• First Posted (Estimate): April 14, 2015

Study Record Updates

• Last Update Posted (Estimate): April 14, 2015
• Last Update Submitted That Met QC Criteria: April 13, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Orthodontics; Nitinol
• Other Study ID Numbers: UMA887599