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

S

Sichuan University

Status

Completed

Conditions

Quality of Life
Anxiety
Pain

Treatments

Device: clear aligners or fixed appliances

Study type

Observational

Funder types

Other

Identifiers

NCT03656471
WCHSIRB-D-2013-108

Details and patient eligibility

About

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

Full 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.

Enrollment

160 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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).

Trial design

160 participants in 2 patient groups

Clear aligner group
Description:
Patients receiving clear aligner treatments for their malocclusions
Treatment:
Device: clear aligners or fixed appliances
Fixed appliance group
Description:
Patients receiving fixed appliance treatments for their malocclusions
Treatment:
Device: clear aligners or fixed appliances

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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