Alignment Efficiency of Two Thermal Activated Orthodontic Archwire Sequences

Crowding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02415673
• Other study ID #: UMA887599
• Status: Completed
• Phase: N/A
• First received: April 9, 2015
• Last updated: April 13, 2015
• Start date: August 2010
• Est. completion date: October 2011

Study information

• Verified date: April 2015
• Source: Faculty Sao Leopoldo Mandic Campinas
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: October 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crowding

Intervention

Device:
• Fixed orthodontics appliance and arch wire
Two nickel-titanium alignment and leveling sequences were employed

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Faculty Sao Leopoldo Mandic Campinas

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Degree of crowding measured on plaster casts using Little's Irregularity Index		6 months
Secondary	crowding survival time		six months