Alignment Efficiency of Two Thermal Activated Orthodontic Archwire Sequences

NCT ID: NCT02415673

Last Updated: 2015-04-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2011-10-31

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

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.

Conditions

Crowding

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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).

Group Type: EXPERIMENTAL

Fixed orthodontics appliance and arch wire

Intervention Type: DEVICE

Two nickel-titanium alignment and leveling sequences were employed

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)

Group Type: EXPERIMENTAL

Fixed orthodontics appliance and arch wire

Intervention Type: DEVICE

Two nickel-titanium alignment and leveling sequences were employed

Interventions

Fixed orthodontics appliance and arch wire

Two nickel-titanium alignment and leveling sequences were employed

Intervention Type: DEVICE

Other Intervention Names

the alignment of mandibular anterior crowding

Eligibility Criteria

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.

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Faculty Sao Leopoldo Mandic Campinas

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

UMA887599

Identifier Type: -

Identifier Source: org_study_id