Self-reported and Experimental Pain in Patients Undergoing Orthodontic Treatment

NCT06426238 | Completed

• 1 other identifier: CIRB_23010
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pain

Keywords

Pressure pain threshold; Clear aligners; Orthodontic appliance; Adolescents; Self-reported pain

Outcome Measures

Primary Outcomes (2)

• Self-reported pain intensity

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

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

• Pressure Pain Threshold

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

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

Secondary Outcomes (3)

• Anxiety and depression symptoms

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

• Pain catastrophizing

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

• Past pain experience

  At T0: Baseline (pre-intervention)

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients starting an orthodontic treatment (clear aligners or fixed braces) at the Multispecialty Clinic of Midwestern University

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Midwestern University: lead

Study Sites (1)

Midwestern University

Downers Grove, Illinois, 60515, United States

Location

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 7, 2024
• First Posted: May 23, 2024
• Study Start: January 3, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: June 8, 2025

Record last verified: 2025-06

Locations

US (1)