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Completed

NCT Number: NCT03656471

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

clear aligners or fixed appliances

Device

Patients choose clear aligners or fixed appliances to treat their malocclusions

Primary outcomes

  1. The chronological changes in pain perception

    Time frame: 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 outcomes

  1. The chronological changes of anxiety level

    Time frame: 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.

  2. The chronological changes in quality of life

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Sep 4, 2018
Registry last updated
Sep 4, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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