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

Completed

• Conditions: Anxiety; Quality of Life; Pain
• Interventions: Device: clear aligners or fixed appliances

• Registration Number: NCT03656471
• Lead Sponsor: West China Hospital

Brief Summary

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

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 Timeline

• Study Start: 2013-12-03
• Primary Completion: 2015-12-03
• Study Completion: 2016-02-01
• Status Verified: 2018-08
• Study First Submitted: 2018-08-30
• Study First Submitted QC: 2018-08-30
• Last Update Submitted: 2018-08-30
• Study First Posted: 2018-09-04
• Last Update Posted: 2018-09-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Fixed appliance group	clear aligners or fixed appliances	Patients receiving fixed appliance treatments for their malocclusions
Clear aligner group	clear aligners or fixed appliances	Patients receiving clear aligner treatments for their malocclusions

Primary Outcome Measures

Name	Time	Method
The chronological changes in pain perception	Baseline, Day 1, Day 2，Day 3，Day 4，Day 5，Day 6，Day 7,and Day 14	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.

Secondary Outcome Measures

Name	Time	Method
The chronological changes of anxiety level	Baseline, Day 1,Day 3,Day 5,Day 7 and Day 14	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.
The chronological changes in quality of life	Baseline,Day 1 ,Day 7 and Day 14	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.