PainNCT06426238
Self-reported and Experimental Pain in Patients Undergoing Orthodontic Treatment
An observational study of Pain, run by Midwestern University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Pain
- How many people
- 38 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2024to 1 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 years and older
- All sexes
- Child, Adult, Older adult
Study population: Patients starting an orthodontic treatment (clear aligners or fixed braces) at the Multispecialty Clinic of Midwestern University
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Midwestern University
Downers Grove, Illinois, 60515
About this study
Official title: Comparison of Self-reported and Experimental Pain Outcomes Between Clear Aligners and Fixed Appliances in Patients Undergoing Orthodontic Treatment
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
- Medical subject headings
- Pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: At three timepoints through study completion: at baseline, at 4-6 weeks, and at 8-12 weeks
Secondary outcomes (3)
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)
Measured: At two timepoints through study completion: at baseline, and at 8-12 weeks
Pain catastrophizing
Self-reported pain catastrophizing measured trough Pain Catastrophizing Scale, PCS (from 0 to 52, with values >30 identifying clinically meaningful pain catastrophizing)
Measured: At two timepoints through study completion: at baseline, and at 8-12 weeks
Past pain experience
Semi-structural interview through questionnaire
Measured: At T0: Baseline (pre-intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2024
- Study start3 Jan 2024
- Primary completion1 Jun 2025
- Study completion1 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Midwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06426238
- Sponsor's protocol ID
- CIRB_23010
- Status last verified
- Jun 2025
- First submitted
- 7 May 2024
- Last updated
- 8 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Self-reported and Experimental Pain Outcomes Between Clear Aligners and Fixed Appliances in Patients Undergoing Orthodontic Treatment
- ClinicalTrials.gov ID
- NCT06426238
- Acronym / sponsor ID
- CIRB_23010
- Conditions
- Pain
- Keywords
- Pressure pain threshold, Clear aligners, Orthodontic appliance, Adolescents, Self-reported pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Midwestern UniversityUniversity, hospital or other
- Study start
- 3 Jan 2024 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 1 Jun 2025 (actual)
- First posted
- 23 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Patients starting an orthodontic treatment (clear aligners or fixed braces) at the Multispecialty Clinic of Midwestern University
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Self-reported pain intensity
Time frame: 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
Time frame: 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
3 secondary outcomes
Anxiety and depression symptoms
Time frame: At two timepoints through study completion: at baseline, and at 8-12 weeks
Pain catastrophizing
Time frame: At two timepoints through study completion: at baseline, and at 8-12 weeks
Past pain experience
Time frame: At T0: Baseline (pre-intervention)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, run by Midwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported pain intensity (time frame: At three timepoints through study completion: at baseline, at 4-6 weeks, and at 8-12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2025.