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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03656471
• Other study ID #: WCHSIRB-D-2013-108
• Status: Completed
• Start date: December 3, 2013
• Est. completion date: February 1, 2016

Study information

• Verified date: August 2018
• Source: West China Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: February 1, 2016
• Est. primary completion date: December 3, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Anxiety
• Pain
• Quality of Life

Intervention

Device:
• clear aligners or fixed appliances
Patients choose clear aligners or fixed appliances to treat their malocclusions

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
West China Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 pain"anchor 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	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
Secondary	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