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NOT YET RECRUITING
NCT07591454
NA

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

Sponsor: 3D-Aligners

View on ClinicalTrials.gov

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.

Official title: Comparison Between The Efficiency Of Elastomeric And Nickel-Titanium Separators In Tooth Separation, Pain Perception, And Gingival Inflammation - A Randomized Controlled Trial

Key Details

Gender

All

Age Range

16 Years - 25 Years

Study Type

INTERVENTIONAL

Enrollment

30

Start Date

2026-06-01

Completion Date

2027-02-01

Last Updated

2026-05-15

Healthy Volunteers

No

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