## Protocol Section
### Identification Module
**NCT ID:** NCT06426238

**Brief Title:** Self-reported and Experimental Pain in Patients Undergoing Orthodontic Treatment

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

#### Organization Study ID Info
**ID:** CIRB_23010
#### Organization
**Class:** OTHER
**Full Name:** Midwestern University
### Status Module
#### Completion Date
**Date:** 2025-08

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-23

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-17

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2025-08

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-01-03

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-23
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-07
**Study First Submit QC Date:** 2024-05-17
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Midwestern University

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**Conditions:**

- Pain

**Keywords:**

- Pressure pain threshold

- Clear aligners

- Orthodontic appliance

- Adolescents

- Self-reported pain

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 38

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Outcomes Module

#### Primary Outcomes

**Description:** Self-reported pain will be assessed using a Visual Analogue Scale with anchors from 0 (=no pain) to 10 (=worst imaginable pain)

**Measure:** Self-reported pain intensity

**Time Frame:** At three timepoints through study completion: at baseline, at 4-6 weeks, and at 8-12 weeks

**Description:** Pressure Pain Threshold will be measured through an algometer on masseter and temporals muscles

**Measure:** Pressure Pain Threshold

**Time Frame:** At three timepoints through study completion: at baseline, at 4-6 weeks, and at 8-12 weeks

#### Secondary Outcomes

**Description:** 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)

**Measure:** Anxiety and depression symptoms

**Time Frame:** At two timepoints through study completion: at baseline, and at 8-12 weeks

**Description:** Self-reported pain catastrophizing measured trough Pain Catastrophizing Scale, PCS (from 0 to 52, with values \>30 identifying clinically meaningful pain catastrophizing)

**Measure:** Pain catastrophizing

**Time Frame:** At two timepoints through study completion: at baseline, and at 8-12 weeks

**Description:** Semi-structural interview through questionnaire

**Measure:** Past pain experience

**Time Frame:** At T0: Baseline (pre-intervention)

### Eligibility Module

**Eligibility 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.

**Minimum Age:** 14 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- CHILD

- ADULT

- OLDER_ADULT

**Study Population:** Patients starting an orthodontic treatment (clear aligners or fixed braces) at the Multispecialty Clinic of Midwestern University

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** lsanga@midwestern.edu

**Name:** Linda Sangalli, DDS, MS, PhD

**Phone:** 630-515-7369

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Downers Grove

**Contacts:**

***Contact 1:***

- **Name:** Linda Sangalli, DDS, MS, PhD

- **Role:** CONTACT

***Contact 2:***

- **Name:** Linda Sangalli, DDS, MS, PhD

- **Role:** PRINCIPAL_INVESTIGATOR

***Contact 3:***

- **Name:** Jahnavi Rao, DDS, MS

- **Role:** SUB_INVESTIGATOR

**Country:** United States

**Facility:** Midwestern University

**State:** Illinois

**Status:** RECRUITING

**Zip:** 60515

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M13066

- Name: Pain

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
