Comparison of Subjective Experiences Between Patients Receiving Clear Aligners or Fixed Appliances

NCT03656471 | Completed

• 1 other identifier: WCHSIRB-D-2013-108
• Study Type: observational
• Target: 160
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aimed to compare experiences between adult patients receiving clear aligners and fixed appliances during the initial stage of orthodontic treatments.

Conditions

Pain; Anxiety; Quality of Life

Outcome Measures

Primary Outcomes (1)

• The chronological changes in pain perception

  The chronological changes in pain perception during the fortnight of orthodontic treatment were assessed through visual analogue scale (VAS). Participant is asked to place a line perpendicular to the VAS line.The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain"anchor and the patients' mask,providing a range of scores from 0-100. A higher score indicates greater pain.

  Baseline, Day 1, Day 2，Day 3，Day 4，Day 5，Day 6，Day 7,and Day 14

Secondary Outcomes (2)

• The chronological changes of anxiety level

  Baseline, Day 1,Day 3,Day 5,Day 7 and Day 14

• The chronological changes in quality of life

  Baseline,Day 1 ,Day 7 and Day 14

Study Arms (2)

Clear aligner group

Patients receiving clear aligner treatments for their malocclusions

Device: clear aligners or fixed appliances

Fixed appliance group

Patients receiving fixed appliance treatments for their malocclusions

Device: clear aligners or fixed appliances

Interventions

clear aligners or fixed appliances DEVICE

Patients choose clear aligners or fixed appliances to treat their malocclusions

Clear aligner group; Fixed appliance group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients receiving either clear aligner or conventional fixed appliance treatments from December 2013 to December 2015 in West China Hospital of Stomatology were enrolled in this study.

You may qualify if:

• Must be 18 years of age or older;
• Must be in good general health;
• Upper and lower arches were both involved in two groups;
• The fixed appliances group must be treated with wires and brackets only with the initial arch wire of 0.012 NiTi ;
• Must be willing to sign and give written informed consent in accordance with institutional and federal guidelines.

You may not qualify if:

• Once been undergoing with orthodontic treatment;
• Experienced tooth ache recently;
• Been diagnosed with contagious and/or systematical diseases;
• Have taken any kind of painkillers three days before the initial treatment;
• When Trait Anxiety Inventory (T-AI) shows a score believed to define a psychological state of over anxiety (male over 53 points and female over 55 points).

Sponsors & Collaborators

• West China Hospital: lead

MeSH Terms

Conditions

Pain; Anxiety Disorders

Interventions

Orthodontic Appliances, Fixed

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Orthodontic Appliances; Orthodontics; Dentistry

Study Officials

• Hu Long, PhD

  West China Hospital of Stomatology, Sichuan University, Chengdu, China

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Target Duration: 14 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 30, 2018
• First Posted: September 4, 2018
• Study Start: December 3, 2013
• Primary Completion: December 3, 2015
• Study Completion: February 1, 2016
• Last Updated: September 4, 2018

Record last verified: 2018-08