NCT02415673

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

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
44

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2010

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2010

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2011

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

April 9, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

April 14, 2015

Completed
Last Updated

April 14, 2015

Status Verified

April 1, 2015

Enrollment Period

8 months

First QC Date

April 9, 2015

Last Update Submit

April 13, 2015

Conditions

Keywords

OrthodonticsNitinol

Outcome Measures

Primary Outcomes (1)

  • Degree of crowding measured on plaster casts using Little's Irregularity Index

    6 months

Secondary Outcomes (1)

  • crowding survival time

    six months

Study Arms (2)

NiTi Af 37ºC

EXPERIMENTAL

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

NiTi Af 35ºC

EXPERIMENTAL

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

Interventions

Two nickel-titanium alignment and leveling sequences were employed

Also known as: the alignment of mandibular anterior crowding
NiTi Af 35ºCNiTi Af 37ºC

Eligibility Criteria

Age15 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Crowding

Condition Hierarchy (Ancestors)

Spatial BehaviorBehavior

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
SPONSOR

Study Record Dates

First Submitted

April 9, 2015

First Posted

April 14, 2015

Study Start

August 1, 2010

Primary Completion

April 1, 2011

Study Completion

October 1, 2011

Last Updated

April 14, 2015

Record last verified: 2015-04