Comparing pain levels in orthodontic treatments with clear aligners and fixed braces
Comparison of Self-reported and Experimental Pain Outcomes Between Clear Aligners and Fixed Appliances in Patients Undergoing Orthodontic Treatment
This study is testing whether people using clear aligners or fixed braces feel more pain during their orthodontic treatment over five days after adjustments.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 38 (estimated) |
| Ages | 14 Years and up |
| Sex | All |
| Sponsor | Midwestern University Academic / other |
| Locations | 1 site (Downers Grove, Illinois) |
| Trial ID | NCT06426238 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate and compare self-reported pain and experimental pain perception in patients undergoing orthodontic treatment with either clear aligners or fixed appliances. It will utilize Pressure Pain Threshold (PPT) as an objective measure to assess pain levels at various time points during the treatment phase. The study will focus on patients starting treatment at Midwestern University and will track pain perception over five days following appliance adjustments.
Who should consider this trial
Good fit: Ideal candidates are adolescents over 14 years old beginning orthodontic treatment with either clear aligners or fixed appliances.
Not a fit: Patients with systemic conditions affecting pain perception or untreated dental issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into pain management strategies for orthodontic patients.
How similar studies have performed: While studies have assessed pain levels in orthodontics, this approach using PPT for comparison between aligners and fixed braces is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Downers Grove, Illinois
- Midwestern University — Downers Grove, Illinois, United States (Recruiting)
Study contacts
- Study coordinator: Linda Sangalli, DDS, MS, PhD
- Email: lsanga@midwestern.edu
- Phone: 630-515-7369
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.