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

NCT ID: NCT03656471

Last Updated: 2018-09-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

160 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-03

Study Completion Date

2016-02-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Pain Anxiety Quality of Life

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Clear aligner group

Patients receiving clear aligner treatments for their malocclusions

clear aligners or fixed appliances

Intervention Type DEVICE

Patients choose clear aligners or fixed appliances to treat their malocclusions

Fixed appliance group

Patients receiving fixed appliance treatments for their malocclusions

clear aligners or fixed appliances

Intervention Type DEVICE

Patients choose clear aligners or fixed appliances to treat their malocclusions

Interventions

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clear aligners or fixed appliances

Patients choose clear aligners or fixed appliances to treat their malocclusions

Intervention Type DEVICE

Eligibility Criteria

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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).
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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West China Hospital

OTHER

Sponsor Role lead

Responsible Party

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Meiya Gao

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hu Long, PhD

Role: PRINCIPAL_INVESTIGATOR

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

Other Identifiers

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WCHSIRB-D-2013-108

Identifier Type: -

Identifier Source: org_study_id

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