Self-reported and Experimental Pain in Patients Undergoing Orthodontic Treatment

Recruiting

• Conditions: Pain

• Registration Number: NCT06426238
• Lead Sponsor: Midwestern University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-03
• Status Verified: 2024-05
• Study First Submitted: 2024-05-07
• Study First Submitted QC: 2024-05-17
• Last Update Submitted: 2024-05-17
• Study First Posted: 2024-05-23
• Last Update Posted: 2024-05-23
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 38

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Self-reported pain intensity	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)
Pressure Pain Threshold	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 Outcome Measures

Name	Time	Method
Past pain experience	At T0: Baseline (pre-intervention)	Semi-structural interview through questionnaire
Anxiety and depression symptoms	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)
Pain catastrophizing	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)

Trial Locations

Locations (1)

Midwestern University; 🇺🇸 Downers Grove, Illinois, United States