Comparison of Subjective Experiences Between Patients Receiving Clear Aligners or Fixed Appliances During the Initial Stage of Orthodontic Treatment
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Pain
- Sponsor
- West China Hospital
- Enrollment
- 160
- Primary Endpoint
- The chronological changes in pain perception
- Status
- Completed
- Last Updated
- 7 years ago
Overview
Brief Summary
This study aimed to compare experiences between adult patients receiving clear aligners and fixed appliances during the initial stage of orthodontic treatments.
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.
Investigators
Meiya Gao
Principal Investigator
West China Hospital
Eligibility 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).
Outcomes
Primary Outcomes
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
- The chronological changes of anxiety level(Baseline, Day 1,Day 3,Day 5,Day 7 and Day 14)
- The chronological changes in quality of life(Baseline,Day 1 ,Day 7 and Day 14)