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Pain and Activity Levels After Orthodontic Separators

NCT05615688 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 94

Last updated 2025-10-16

No results posted yet for this study

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.

Conditions

  • Dental Malocclusion

Interventions

PROCEDURE

Pain Intensity following Placement of Orthodontic Separators

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.

Sponsors & Collaborators

  • Lina Sharab

    lead OTHER

Principal Investigators

  • Lina Sharab, DDS, MS, MSc · Assistant Professor, Orthodontics

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
15 Years
Max Age
49 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-07-14
Primary Completion
2025-09-30
Completion
2025-09-30

Countries

  • United States

Study Locations

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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 NCT05615688 on ClinicalTrials.gov