PainNCT03656471
Comparison of Subjective Experiences Between Patients Receiving Clear Aligners or Fixed Appliances
An observational study of Pain and Anxiety, run by West China Hospital.
Trial summary
This study aimed to compare experiences between adult patients receiving clear aligners and fixed appliances during the initial stage of orthodontic treatments. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Pain, Anxiety, Quality of Life
- What is being tested?
- clear aligners or fixed appliances
- Type of treatment
- Medical device
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 3 Dec 2013to 1 Feb 2016
- How long will I take part?
- 14 Days
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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).
About this study
Official title: Comparison of Subjective Experiences Between Patients Receiving Clear Aligners or Fixed Appliances During the Initial Stage of Orthodontic Treatment
This study aimed to compare experiences between adult patients receiving clear aligners and fixed appliances during the initial stage of orthodontic treatments.
Read the 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.
- Conditions
- Pain, Anxiety, Quality of Life
- Being tested
- clear aligners or fixed appliances
- Medical subject headings
- Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clear aligners or fixed appliancesDevice
Patients choose clear aligners or fixed appliances to treat their malocclusions
| Study group | Role | What they receive |
|---|---|---|
| Clear aligner group | Patients receiving clear aligner treatments for their malocclusions Receives: Device: clear aligners or fixed appliances | |
| Fixed appliance group | Patients receiving fixed appliance treatments for their malocclusions Receives: Device: clear aligners or fixed appliances |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Day 1, Day 2，Day 3，Day 4，Day 5，Day 6，Day 7,and Day 14
Secondary outcomes (2)
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.
Measured: 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.
Measured: Baseline,Day 1 ,Day 7 and Day 14
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start3 Dec 2013
- Primary completion3 Dec 2015
- Study completion1 Feb 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by West China HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
- Target duration
- 14 Days
Sponsor and investigators
- Lead sponsor
- West China Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Meiya Gao, West China Hospital
- Investigators
- Hu Long, PhD, Principal investigator, West China Hospital of Stomatology, Sichuan University, Chengdu, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03656471
- Sponsor's protocol ID
- WCHSIRB-D-2013-108
- Status last verified
- Aug 2018
- First submitted
- 30 Aug 2018
- Last updated
- 4 Sep 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Subjective Experiences Between Patients Receiving Clear Aligners or Fixed Appliances During the Initial Stage of Orthodontic Treatment
- ClinicalTrials.gov ID
- NCT03656471
- Acronym / sponsor ID
- WCHSIRB-D-2013-108
- Conditions
- Pain, Anxiety, Quality of Life
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- West China HospitalUniversity, hospital or other
- Study start
- 3 Dec 2013 (actual)
- Primary completion
- 3 Dec 2015 (actual)
- Study completion
- 1 Feb 2016 (actual)
- First posted
- 4 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 14 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clear aligner group | – | Device: clear aligners or fixed appliancesPatients receiving clear aligner treatments for their malocclusions |
| Fixed appliance group | – | Device: clear aligners or fixed appliancesPatients receiving fixed appliance treatments for their malocclusions |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| clear aligners or fixed appliancesPatients choose clear aligners or fixed appliances to treat their malocclusions | Device | Clear aligner group, Fixed appliance group |
Primary outcome
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.
2 secondary outcomes
The chronological changes of anxiety level
Time frame: Baseline, Day 1,Day 3,Day 5,Day 7 and Day 14
The chronological changes in quality of life
Time frame: Baseline,Day 1 ,Day 7 and Day 14
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Hu Long, PhD principal investigator
West China Hospital of Stomatology, Sichuan University, Chengdu, China
Questions about this trial
What is this clinical trial studying?
An observational study of Pain and Anxiety, run by West China Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Sep 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2018.