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Alignment Efficiency of Two Thermal Activated Orthodontic Archwire Sequences

Sponsor
Faculty Sao Leopoldo Mandic Campinas (Other)
Overall Status
Completed
CT.gov ID
NCT02415673
Collaborator
(none)
44
Enrollment
2
Arms
14
Duration (Months)

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: Fixed orthodontics appliance and arch wire
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
44 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Alignment Efficiency of Two Thermal Activated Orthodontic Archwire Sequences Based on Transition Temperature Range: A Randomized Clinical Trial
Study Start Date :
Aug 1, 2010
Actual Primary Completion Date :
Apr 1, 2011
Actual Study Completion Date :
Oct 1, 2011

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Degree of crowding measured on plaster casts using Little's Irregularity Index [6 months]

    Secondary Outcome Measures

    1. crowding survival time [six months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    15 Years to 25 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Faculty Sao Leopoldo Mandic Campinas

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Faculty Sao Leopoldo Mandic Campinas
    ClinicalTrials.gov Identifier:
    NCT02415673
    Other Study ID Numbers:
    • UMA887599
    First Posted:
    Apr 14, 2015
    Last Update Posted:
    Apr 14, 2015
    Last Verified:
    Apr 1, 2015
    Keywords provided by Faculty Sao Leopoldo Mandic Campinas
    Orthodontics
    Nitinol

    Study Results

    No Results Posted as of Apr 14, 2015