RelapseNCT05915273
Relapse and Failure Rates Between CAD/CAM and Conventional Fixed Retainers
A study testing Computer Aided Design/ Computer Aided Manufacturing Retainers, Lab-based Retainers and Chairside Retainers in people with Relapse, run by Nourhan M.Aly at 1 site in United States.
Trial summary
The aim of this study was to compare the differences in relapse and failure rates in patients treated with fixed retainers (FRs) using Computer-Aided Design/Computer-Aided Manufacturing technology, lab-based technique, and chairside method. Read more about this study
- Who is it for?
- Ages 13 years and older
- Conditions the study is for
- Relapse
- What is being tested?
- Computer Aided Design/ Computer Aided Manufacturing Retainers, Lab-based Retainers and Chairside Retainers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2019to 30 Sep 2022
- 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 13 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- completion of comprehensive orthodontic treatment
- class I molar and canine relationships
- indication for a fixed retainer on the mandibular anterior teeth.
- no extractions done as part of their treatment.
- Treatment with preadjusted edgewise appliance.
Who cannot join
- refusal to participate
- refusal to have fixed retainers
- poor oral hygiene
- non-compliance
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Relapse and Failure Rates Between CAD/CAM and Conventional Fixed Retainers: A 2-year Follow-up of a Randomized Controlled Clinical Trial
The aim of this study was to compare the differences in relapse and failure rates in patients treated with fixed retainers (FRs) using Computer-Aided Design/Computer-Aided Manufacturing technology, lab-based technique, and chairside method.
- Conditions
- Relapse
- Being tested
- Computer Aided Design/ Computer Aided Manufacturing Retainers, Lab-based Retainers, Chairside Retainers
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computer Aided Design/ Computer Aided Manufacturing RetainersOther
Also called CAD/CAM
Custom-bent fixed retainer wires from an in-office CAD/CAM system with FixR software and the BenderI machine (YOAT Corporation, Lynwood, WA). Dentaflex wires- round, 0.5mm in diameter, three-stranded Stainless Steel (Dentaurum GmbH \& Co., Ispringen, Germany)- were used for the CAD/CAM group
Lab-based RetainersOther
The lab group used the same type of wire as the CAD/CAM group but was manually bent by a lab technician
Chairside RetainersOther
The chairside group used three-stranded Stainless Steel, 0.974mm x 0.402 mm, flexible Ortho-FlexTech wires (Reliance, Itasca, IL)
| Study group | Role | What they receive |
|---|---|---|
| CAD/CAM group | Experimental | Not described Receives: Other: Computer Aided Design/ Computer Aided Manufacturing Retainers |
| Lab group | Active comparator | Not described Receives: Other: Lab-based Retainers |
| Chairside group | Active comparator | Not described Receives: Other: Chairside Retainers |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in intercanine width (ICW)
ICW was measured on the Meshlab software using the 3D ruler measurement tool. Pre-treatment, post-treatment, and post-retention measures were recorded and any change in the ICW was considered relapse.
Measured: 2 years
Change in Little's Irregularity Index (LII)
ICW was measured on the Meshlab software using the 3D ruler measurement tool. Pre-treatment, post-treatment, and post-retention measures were recorded and any change in the LII was considered relapse.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Sep 2019
- Primary completion1 Sep 2022
- Study completion30 Sep 2022
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 RelapseStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nourhan M.Aly
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Nourhan M.Aly, University of Alexandria
- Investigators
- Giau Tran, Principal investigator, Department of Orthodontics, Saint Louis University, Saint Louis, MO, USA.Ryan Rucker, Principal investigator, Department of Orthodontics, Saint Louis University, Saint Louis, MO, USA.Patrick Foley, PhD, Study chair, Department of Orthodontics, Saint Louis University, Saint Louis, MO, USA.Brent Bankhead, Study chair, Department of Orthodontics, Saint Louis University, Saint Louis, MO, USA.Samar M Adel, PhD, Study director, Alexandria UniversityKi B Kim, Study director, Department of Orthodontics, Saint Louis University, Saint Louis, MO, USA.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05915273
- Sponsor's protocol ID
- 32524
- Status last verified
- Jun 2023
- First submitted
- 13 Jun 2023
- Last updated
- 22 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tran G, Rucker R, Foley P, Bankhead B, Adel SM, Kim KB. Relapse and failure rates between CAD/CAM and conventional fixed retainers: a 2-year follow-up of a randomized controlled clinical trial. Eur J Orthod. 2024 Jan 1;46(1):cjad079. doi: 10.1093/ejo/cjad079.
PubMed 38168815
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Relapse and Failure Rates Between CAD/CAM and Conventional Fixed Retainers: A 2-year Follow-up of a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT05915273
- Acronym / sponsor ID
- 32524
- Conditions
- Relapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Nourhan M.AlyUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Sep 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 22 Jun 2023 (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.
The aim of this study was to compare the differences in relapse and failure rates in patients treated with fixed retainers (FRs) using Computer-Aided Design/Computer-Aided Manufacturing technology, lab-based technique, and chairside method.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CAD/CAM group | Experimental | Other: Computer Aided Design/ Computer Aided Manufacturing Retainers |
| Lab group | Active comparator | Other: Lab-based Retainers |
| Chairside group | Active comparator | Other: Chairside Retainers |
Who may qualify
- Ages
- 13 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- completion of comprehensive orthodontic treatment
- class I molar and canine relationships
- indication for a fixed retainer on the mandibular anterior teeth.
- no extractions done as part of their treatment.
- Treatment with preadjusted edgewise appliance.
Key exclusion criteria (4 listed)
- refusal to participate
- refusal to have fixed retainers
- poor oral hygiene
- non-compliance
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 |
|---|---|---|
| Computer Aided Design/ Computer Aided Manufacturing RetainersAlso: CAD/CAMCustom-bent fixed retainer wires from an in-office CAD/CAM system with FixR software and the BenderI machine (YOAT Corporation, Lynwood, WA). Dentaflex wires- round, 0.5mm in diameter, three-stranded Stainless Steel (Dentaurum GmbH \& Co., Ispringen, Germany)- were used for the CAD/CAM group | Other | CAD/CAM group |
| Lab-based RetainersThe lab group used the same type of wire as the CAD/CAM group but was manually bent by a lab technician | Other | Lab group |
| Chairside RetainersThe chairside group used three-stranded Stainless Steel, 0.974mm x 0.402 mm, flexible Ortho-FlexTech wires (Reliance, Itasca, IL) | Other | Chairside group |
Primary outcome
Change in intercanine width (ICW)
Time frame: 2 years
ICW was measured on the Meshlab software using the 3D ruler measurement tool. Pre-treatment, post-treatment, and post-retention measures were recorded and any change in the ICW was considered relapse.
Change in Little's Irregularity Index (LII)
Time frame: 2 years
ICW was measured on the Meshlab software using the 3D ruler measurement tool. Pre-treatment, post-treatment, and post-retention measures were recorded and any change in the LII was considered relapse.
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 22 Jun 2023.
- Derived from this study: PubMed 38168815Tran G, Rucker R, Foley P, Bankhead B, Adel SM, Kim KB. Relapse and failure rates between CAD/CAM and conventional fixed retainers: a 2-year follow-up of a randomized controlled clinical trial. Eur J Orthod. 2024 Jan 1;46(1):cjad079. doi: 10.1093/ejo/cjad079.
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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.
Giau Tran principal investigator
Department of Orthodontics, Saint Louis University, Saint Louis, MO, USA.
Ryan Rucker principal investigator
Department of Orthodontics, Saint Louis University, Saint Louis, MO, USA.
Patrick Foley, PhD study chair
Department of Orthodontics, Saint Louis University, Saint Louis, MO, USA.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Computer Aided Design/ Computer Aided Manufacturing Retainers, Lab-based Retainers and Chairside Retainers in people with Relapse, run by Nourhan M.Aly at 1 site in United States.
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 4 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 22 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Change in intercanine width (ICW) (time frame: 2 years). The study lists 2 primary outcomes in all. 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 NCT05915273, 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 22 Jun 2023.