Clinical Trial

Comparison of Three Orthodontic Separators for Pain, Plaque, and Tooth Separation

Study acronym: SEP-ORTHO
Not Yet Recruiting
View on ClinicalTrials.gov →
Summary
Orthodontic separators are small devices placed between teeth before fitting braces to create space for bands. This procedure may cause pain, discomfort, and changes in oral hygiene, which can affect plaque buildup and daily activities. This study aims to compare three commonly used types of orthodontic separators-elastomeric, Kesling, and customized tie wire separators-in terms of the amount of tooth separation achieved, pain experienced by patients, and plaque accumulation. In addition, the study will assess how these separators affect patients' quality of life, including eating, speaking, and daily comfort. Participants will be assigned to one of the three separator types and will be evaluated after 48 to 72 hours. The findings of this study may help identify the most effective and comfortable separator, improving patient care and treatment experience in orthodontics.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-04-08.
Trial Details
NCT Number NCT07532044
Lead Sponsor Islamabad Medical and Dental College
Conditions Orthodontic Pain (D013850), Malocclusion, Orthodontic Treatment
Enrollment 144 participants
Start Date 2026-04-10
Primary Completion 2028-04-10 (estimated)
Study Completion 2028-04-10 (estimated)
Updated on ClinicalTrials.gov 2026-05-08