RetentionNCT02618330
The Clinical Evaluation of Two Different Film Thicknesses of Clear Overlay Retainer.
A study testing retainer in people with Retention, run by Yafen Zhu.
Trial summary
The aims of this study were to compare health related quality of life, comforts degrees，retention effectiveness, and failure rates as well as survival times between two clear overlay retainers with different thicknesses, thus to provide basis information regarding appropriate selections of the thickness of clear… Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Retention
- What is being tested?
- retainer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to Jun 2015
- Phase
- Interventional
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients after active orthodontic treatment;
- Must be healthy without systemic and oral diseases;
- The central incisors, canines and first molars of both upper and lower arches must be existed;
- Agreed to the trial and signed informed consent forms, either by themselves, or their parents.
Who cannot join
- Oral habits such as bruxism and clenching,
- Do not accept this type of retainers
About this study
The aims of this study were to compare health related quality of life, comforts degrees，retention effectiveness, and failure rates as well as survival times between two clear overlay retainers with different thicknesses, thus to provide basis information regarding appropriate selections of the thickness of clear overlay retainers.
- Conditions
- Retention
- Being tested
- retainer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retainerDevice
24 h wearing whether 0.75-mm-thick or 1.00-mm-thick film retainer
| Study group | Role | What they receive |
|---|---|---|
| retainer: 0.75-mm-thick film | Experimental | Not described Receives: Device: retainer |
| retainer: 1.00-mm-thick film | Experimental | Not described Receives: Device: retainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survival times via recording to the patients' re-visit
Measured: one year
Secondary outcomes (3)
SF-36 scale for Quality of life
Measured: one month
Comfort degrees assessed through Visual Analog Score
Measured: one month
Retention effectiveness assessed according to 3D models
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2015 (estimated)
- Study startJul 2013
- Primary completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for RetentionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yafen Zhu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yafen Zhu, Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02618330
- Sponsor's protocol ID
- WCHSIRB-ST-2013-094
- Status last verified
- Nov 2015
- First submitted
- 25 Nov 2015
- Last updated
- 3 Dec 2015
- Results posted
- No
Publications
Zhu Y, Lin J, Long H, Ye N, Huang R, Yang X, Jian F, Lai W. Comparison of survival time and comfort between 2 clear overlay retainers with different thicknesses: A pilot randomized controlled trial. Am J Orthod Dentofacial Orthop. 2017 Mar;151(3):433-439. doi: 10.1016/j.ajodo.2016.10.019.
PubMed 28257727
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Evaluation of Two Different Film Thicknesses of Clear Overlay Retainer.
- ClinicalTrials.gov ID
- NCT02618330
- Acronym / sponsor ID
- WCHSIRB-ST-2013-094
- Conditions
- Retention
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Yafen ZhuUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Jun 2015 (actual)
- First posted
- 1 Dec 2015 (estimated)
- 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.
The aims of this study were to compare health related quality of life, comforts degrees，retention effectiveness, and failure rates as well as survival times between two clear overlay retainers with different thicknesses, thus to provide basis information regarding appropriate selections of the thickness of clear overlay retainers.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| retainer: 0.75-mm-thick film | Experimental | Device: retainer |
| retainer: 1.00-mm-thick film | Experimental | Device: retainer |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients after active orthodontic treatment;
- Must be healthy without systemic and oral diseases;
- The central incisors, canines and first molars of both upper and lower arches must be existed;
- Agreed to the trial and signed informed consent forms, either by themselves, or their parents.
Key exclusion criteria (2 listed)
- Oral habits such as bruxism and clenching,
- Do not accept this type of retainers
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 |
|---|---|---|
| retainer24 h wearing whether 0.75-mm-thick or 1.00-mm-thick film retainer | Device | retainer: 0.75-mm-thick film, retainer: 1.00-mm-thick film |
Primary outcome
Survival times via recording to the patients' re-visit
Time frame: one year
3 secondary outcomes
SF-36 scale for Quality of life
Time frame: one month
Comfort degrees assessed through Visual Analog Score
Time frame: one month
Retention effectiveness assessed according to 3D models
Time frame: one year
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 3 Dec 2015.
- Derived from this study: PubMed 28257727Zhu Y, Lin J, Long H, Ye N, Huang R, Yang X, Jian F, Lai W. Comparison of survival time and comfort between 2 clear overlay retainers with different thicknesses: A pilot randomized controlled trial. Am J Orthod Dentofacial Orthop. 2017 Mar;151(3):433-439. doi: 10.1016/j.ajodo.2016.10.019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing retainer in people with Retention, run by Yafen Zhu.
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 4 inclusion and 2 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 3 Dec 2015. 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?
Survival times via recording to the patients' re-visit (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02618330, which also lists 1 linked publication.
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 3 Dec 2015.