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

Study Overview
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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.

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

Conditions
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Pain, Anxiety, Quality of Life

Intervention / Treatment
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* Device: clear aligners or fixed appliances


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Clear aligner group<br>Patients receiving clear aligner treatments for their malocclusions | Device: clear aligners or fixed appliances<br>* Patients choose clear aligners or fixed appliances to treat their malocclusions<br>|
| Fixed appliance group<br>Patients receiving fixed appliance treatments for their malocclusions | Device: clear aligners or fixed appliances<br>* Patients choose clear aligners or fixed appliances to treat their malocclusions<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The chronological changes in pain perception | 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 painanchor and the patients' mask,providing a range of scores from 0-100. A higher score indicates greater pain. | Baseline, Day 1, Day 2，Day 3，Day 4，Day 5，Day 6，Day 7,and Day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The chronological changes of anxiety level | 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. | Baseline, Day 1,Day 3,Day 5,Day 7 and Day 14 | 
| The chronological changes in quality of life | 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. | Baseline,Day 1 ,Day 7 and Day 14 |