CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 94 enrolled
Drug / intervention
Pain Intensity following Placement of Orthodontic Separatorsprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05615688
NCT05615688N/ACompleted

Pain Intensity Following the Placement of Orthodontic Separators in Healthy Volunteers and How it Correlates to Different Levels of Physical Activity?

Lina Sharab·interventional·Posted Nov 14, 2022·Updated Oct 16, 2025

In Brief

A clinical study evaluating Pain Intensity following Placement of Orthodontic Separators for Dental Malocclusion. Completed, enrolled 94 participants across 1 site.

Detailed Summary

The primary aim of this study is to evaluate the reported pain intensity following placement of Orthodontic separators on healthy volunteers aged 15-49 in relation to their recorded physical activity level. Hypothesis 1: The investigators hypothesize that participants with higher daily step counts and physical activity levels will report significantly less pain intensity from orthodontic separators than their less active peers following separator placement. Null hypothesis is that participants with higher daily step counts will report the same pain intensity from orthodontic separators than their less active peers following separator placement The secondary aim is to describe the course of pain, at 24 hr intervals, over the next seven days following separator placement. Hypothesis 2: The investigators hypothesize that more physically active participants will report ratings of zero pain intensity faster (sooner) than their less active peers throughout the one week study. Secondary null hypothesis is that more physically active participants will report ratings of zero pain intensity at the same rate as their less active peers throughout the one week study.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedNov 14, 2022
Enrollment StartJul 14, 2022
Primary CompletionSep 30, 2025
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 3.6 years ago

Interventions

Pain Intensity following Placement of Orthodontic Separatorsprocedure

Elastomeric separators will be placed on the mesial and distal of lower first permanent molars for a total of four separators per subject. Subjects will wear receive an activity monitor prior to placement of elastic separators and instructed to wear it 24/7 unless showering or swimming. Subjects will complete a recurrent Pain Scale Questionnaire 2-4 hrs after placement of elastics and every 24 hrs from day 2- 7.