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

Comparison of Subjective Experiences Between Patients Receiving Clear Aligners or Fixed Appliances During the Initial Stage of Orthodontic Treatment

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

Study Overview

• Status: Completed
• Conditions: Quality of Life; Pain; Anxiety
• Intervention / Treatment: Device: clear aligners or fixed appliances

Detailed Description

Patients receiving either clear aligner treatments were enrolled in this study. During the same time period, patients receiving fixed orthodontic treatments well-matched with clear-aligner patients by similar ages (difference < 3 years), same gender and similar levels of severity of malocclusion [similar Index of Complexity Outcome and Need (ICON) level] were enrolled.The two groups were well-matched with ages, gender and levels of malocclusion severity. Pain perception, anxiety and quality of life were assessed through visual analogue scale (VAS), state-trait anxiety inventory (STAI) and oral health impact profile-14 (OHIP-14), respectively.

• Study Type: Observational
• Enrollment (Actual): 160

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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).

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Clear aligner group; Patients receiving clear aligner treatments for their malocclusions	Device: clear aligners or fixed appliances; Patients choose clear aligners or fixed appliances to treat their malocclusions
Fixed appliance group; Patients receiving fixed appliance treatments for their malocclusions	Device: clear aligners or fixed appliances; Patients choose clear aligners or fixed appliances to treat their malocclusions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
The chronological changes of anxiety level	Secondary outcomes concerning chronological changes of anxiety were assessed before and after orthodontic treatments through state-trait anxiety inventory (ST-AI). A higher score indicates higher anxiety level.	Baseline, Day 1,Day 3,Day 5,Day 7 and Day 14
The chronological changes in quality of life	Secondary outcomes concerning chronological changes of anxiety of life were assessed before and after orthodontic treatments through oral health impact profile-14 (OHIP-14).A higher score indicates lower quality of life.	Baseline,Day 1 ,Day 7 and Day 14

Collaborators and Investigators

• Sponsor: West China Hospital
• Investigators: Principal Investigator: Hu Long, PhD, West China Hospital of Stomatology, Sichuan University, Chengdu, China

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2013
• Primary Completion (Actual): December 3, 2015
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: August 30, 2018
• First Submitted That Met QC Criteria: August 30, 2018
• First Posted (Actual): September 4, 2018

Study Record Updates

• Last Update Posted (Actual): September 4, 2018
• Last Update Submitted That Met QC Criteria: August 30, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: WCHSIRB-D-2013-108

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No