Clinical Trial

Treatment Outcome of Elastomeric and Nickel-Titanium Separators in Tooth Separation

Not Yet Recruiting
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Summary
Patients seeking fixed orthodontic treatment that requires band placement will be enrolled in this study. This trial aims to compare the efficiency of rectangular cross-section nickel-titanium separators with elastomeric separators in creating sufficient interdental space for orthodontic band placement. In addition, the impact of both separator types on pain perception and gingival health during a 3-day placement period will be evaluated. Participants will be allocated to two groups in a split-mouth design. On the experimental side, nickel-titanium separators will be used, while elastomeric separators will be used as the control on the other side. Outcomes will include separation efficacy, pain perception over time, gingival inflammation, analgesic consumption, and separator loss.
Trial Details
NCT Number NCT07591454
Lead Sponsor 3D-Aligners
Conditions Dental Crowding, Malocclusion, Angle Class I
Enrollment 30 participants
Start Date 2026-06-01
Primary Completion 2026-11-01 (estimated)
Study Completion 2027-02-01 (estimated)
Updated on ClinicalTrials.gov 2026-05-15