Skip to main content
OpenTrials
Completed

NCT Number: NCT06426238

Self-reported and Experimental Pain in Patients Undergoing Orthodontic Treatment

Pressure Pain Threshold (PPT) is defined as the minimum force applied to an area that is perceived as pain. PPT is considered an objective measurement tool to assess pain levels. Studies have assessed the difference in pain levels between clear aligners and fixed appliances using subjective pain scales. No study has utilized PPT to evaluate the difference in pain between aligners and fixed braces at different time points. This study will aim to compare the self- reported and experimental pain perception between the clear aligner and fixed appliance therapies during the phase of crown alignment and to assess how long pain is perceived in the following five days from the adjustment of the appliance.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pain Neurologic Manifestations Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Midwestern University

Downers Grove, Illinois, 60515, United States

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • consecutive consented patients (> 14 years old) beginning an orthodontic treatment on both arches, either with aligners or fixed appliance at the Midwestern University, Multidisciplinary Clinic;
  • patients in possession of an email address and Internet connection.

Exclusion criteria

  • patients with generalized systemic conditions known to affect the overall body pain and pressure pain threshold assessment (e.g., fibromyalgia, autoimmune conditions such as multiple sclerosis, rheumatoid arthritis),
  • untreated dental caries.

Treatment and study plan

Primary outcomes

  1. Self-reported pain intensity

    Time frame: At three timepoints through study completion: at baseline, at 4-6 weeks, and at 8-12 weeks

    Self-reported pain will be assessed using a Visual Analogue Scale with anchors from 0 (=no pain) to 10 (=worst imaginable pain)

  2. Pressure Pain Threshold

    Time frame: At three timepoints through study completion: at baseline, at 4-6 weeks, and at 8-12 weeks

    Pressure Pain Threshold will be measured through an algometer on masseter and temporals muscles

Secondary outcomes

  1. Anxiety and depression symptoms

    Time frame: At two timepoints through study completion: at baseline, and at 8-12 weeks

    Self-perceived anxiety and depression measured through the Patient Health Questionnaire, PHQ-4 (from 0 to 12, with higher score identifying higher anxiety and depression)

  2. Pain catastrophizing

    Time frame: At two timepoints through study completion: at baseline, and at 8-12 weeks

    Self-reported pain catastrophizing measured trough Pain Catastrophizing Scale, PCS (from 0 to 52, with values >30 identifying clinically meaningful pain catastrophizing)

  3. Past pain experience

    Time frame: At T0: Baseline (pre-intervention)

    Semi-structural interview through questionnaire

Sponsors and collaborators

Lead sponsor

Midwestern University

Other

Registry information

Official study title

Comparison of Self-reported and Experimental Pain Outcomes Between Clear Aligners and Fixed Appliances in Patients Undergoing Orthodontic Treatment

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 23, 2024
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.