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

NCT07591454 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-05-15

No results posted yet for this study

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.

Conditions

  • Dental Crowding
  • Malocclusion, Angle Class I

Interventions

OTHER

Elastomeric separators

application of the elastomeric separators before application of the orthodontic bands on the first molars

OTHER

Nickel-Titanium separators

application of the Nickel-Titanium separators before application of the orthodontic bands on the first molars

Sponsors & Collaborators

  • 3D-Aligners

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2026-11-01
Completion
2027-02-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07591454 on ClinicalTrials.gov