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

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ClinicalTrials.gov Identifier: NCT03656471
Recruitment Status : Completed
First Posted : September 4, 2018
Last Update Posted : September 4, 2018
Sponsor:
Information provided by (Responsible Party):
Meiya Gao, West China Hospital

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

Condition or disease Intervention/treatment
Pain Anxiety Quality of Life 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 Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 160 participants
Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration: 14 Days
Official Title: Comparison of Subjective Experiences Between Patients Receiving Clear Aligners or Fixed Appliances During the Initial Stage of Orthodontic Treatment
Actual Study Start Date : December 3, 2013
Actual Primary Completion Date : December 3, 2015
Actual Study Completion Date : February 1, 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety Orthodontia

Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

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).
Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03656471


Sponsors and Collaborators
West China Hospital
Investigators
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Principal Investigator: Hu Long, PhD West China Hospital of Stomatology, Sichuan University, Chengdu, China
More Information
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Additional Information:

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Responsible Party: Meiya Gao, Principal Investigator, West China Hospital
ClinicalTrials.gov Identifier: NCT03656471    
Other Study ID Numbers: WCHSIRB-D-2013-108
First Posted: September 4, 2018    Key Record Dates
Last Update Posted: September 4, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No