Pain
Conditions
Keywords
Pressure pain threshold, Clear aligners, Orthodontic appliance, Adolescents, Self-reported pain
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.
Interventions
None listed
Sponsors
Midwestern University
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
14 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
| Past pain experience | At T0: Baseline (pre-intervention) | Semi-structural interview through questionnaire |
Countries
United States
Outcome results
None listed