Self-reported and Experimental Pain in Patients Undergoing Orthodontic Treatment

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06426238
• Other study ID #: CIRB_23010
• Status: Recruiting
• Start date: January 3, 2024
• Est. completion date: August 2025

Study information

• Verified date: May 2024
• Source: Midwestern University
• Contact: Linda Sangalli, DDS, MS, PhD
• Phone: 630-515-7369
• Email: lsanga[@]midwestern.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 38
• Est. completion date: August 2025
• Est. primary completion date: August 2025
• Gender: All
• Age group: 14 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Pain

Locations

Country	Name	City	State
United States	Midwestern University	Downers Grove	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Midwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Anxiety and depression symptoms	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)	At two timepoints through study completion: at baseline, and at 8-12 weeks
Secondary	Pain catastrophizing	Self-reported pain catastrophizing measured trough Pain Catastrophizing Scale, PCS (from 0 to 52, with values >30 identifying clinically meaningful pain catastrophizing)	At two timepoints through study completion: at baseline, and at 8-12 weeks
Secondary	Past pain experience	Semi-structural interview through questionnaire	At T0: Baseline (pre-intervention)