RelapseRetentionNCT04389879
CAD/CAM Fixed Retainers vs. Conventional Multistranded Fixed Retainers in Orthodontic Patients. Comparison of Stability, Retainer Failure Rate, Adverse Effects, Cost-effectiveness, and Patient Satisfaction. A Randomized Controlled Clinical Trial
A study testing Bonding of either CAD/CAM or conventional multistranded stainless steel fixed retainer in people with Relapse, run by University of Aarhus at 2 sites in 2 countries.
Trial summary
Introduction: Orthodontic retainers are used after the completion of orthodontic treatment to assure dental occlusal stability and to maintain the achieved end-result. However, without retention teeth could go back to their initial dental malposition or could even take a different unpredicted position resulting once… Read more about this study
- Who is it for?
- Ages 12 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Relapse
- What is being tested?
- Bonding of either CAD/CAM or conventional multistranded stainless steel fixed retainer
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 1 Sep 2018to Dec 2025
- 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 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy patients.
- Age: 12-25 years old (at time of debonding).
- Presence of all maxillary and mandibular anterior teeth, with normal shape and size.
- Completion of a course of fixed appliance therapy involving both dental arches.
- Subjects willing to consent to the trial and comply with the trial regime.
- No restriction to presenting initial malocclusion, type of active orthodontic treatment undertaken provided that it included full fixed appliances (functional/removable appliances in combination with fixed appliances - extraction or non-extraction)
Who cannot join
- Patients with cleft lip or palate, or both or any other craniofacial syndrome.
- Patients who had surgical correction of the jaws: Le fort I (2- or 3-piece maxilla) or SARPE (surgically assisted rapid palatal expansion).
- Lingual appliance treatments.
- Periodontal disease.
- Hypoplasia of enamel.
- Fluorosis.
Show all 9Show fewer
- Active caries, restorations or fractures in the anterior teeth.
- Patients who have had separate debonding appointments for each jaw, with a difference of more than 2 months in between.
- Re-treated patients.
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: CAD/CAM Fixed Retainers vs. Conventional Multistranded Fixed Retainers in Orthodontic Patients. Comparison of Stability, Retainer Failure Rate, Adverse Effects, Cost-effectiveness, and Patient Satisfaction. A Randomized Controlled Clinical Trial.
Introduction:
Orthodontic retainers are used after the completion of orthodontic treatment to assure dental occlusal stability and to maintain the achieved end-result. However, without retention teeth could go back to their initial dental malposition or could even take a different unpredicted position resulting once again in dental malocclusion (a deviation from normal occlusion).
Read more
There are different types of retainers, some are fixed (glued to the back of the front teeth), and others are removable (can be removed and replaced into the mouth by the patient).
While there are various retainers used for retention (stability), there is no perfect method. Fixed retainers (FRs) are used worldwide. On the one hand, FRs focus on preventing relapse. On the other hand, there are sometimes some adverse effects of retainers; they could fail at a certain point (break/get loose), or cause unwanted tooth movements. Until now, the choice of a retention method is based solely on clinicians' experience as there is no substantial evidence regarding the best retention method or the duration of the retention period. Some clinicians prolong the retention period while others prefer to keep the retainers for an indefinite time.
As the world is advancing, so is the orthodontic science. New FR fabricated by CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing), are assumed to have greater accuracy, better fit, and most importantly, might offer a passive positioning of the retainer. However, the evidence about CAD/CAM FRs is very limited.
Purpose:
To investigate and compare the clinical effectiveness of two types of FRs; CAD/CAM vs. multistranded wire, in terms of stability (primary outcome), failure rate, adverse effects, cost-effectiveness, and patient satisfaction (secondary outcomes), substantial up to 5 years after retainer placement.
Hypotheses:
Compared to traditional multistranded FRs, CAD/CAM FRs have:
- Better long term stability,
- Similar failure rate,
- Fewer adverse effects,
- Similar cost-effectiveness and patient satisfaction.
Read the detailed description
Material and Methods
Setting: Section of Orthodontics, Department of Dentistry and Oral Health, Aarhus University, Denmark and Department of Orthodontics, Faculty of Dentistry, University of Oslo, Norway.
Sample size: 126 participants are needed for this study.
Randomization: After oral and written consent is obtained, allocation to groups, either conventional multistranded Stainless Steel fixed retainers, or CAD/CAM custom-cut Nickel Titanium fixed retainers, will take place at the last appointment before debonding. Subjects will be allocated 1:1 into one of the two groups.
Intervention protocol: After completing a full active orthodontic treatment, at both centers. The achieved treatment end result has to be maintained in the long term in order to prevent relapse (movement of teeth to the initial malocclusion). One of either two different fixed retainers will be bonded (to the upper and lower anterior teeth) by one operator in each center.
This study follows a standard retention protocol procedure carried at both centers and has a long term posttreatment follow-up of 5 years. Patients will be recalled for follow-up appointments after 1, 3, 6, 12, 24, 36 and 60 months. At follow-up visits, we will perform the following: at 1, and 3 months - a clinical examination. At 6, 12, 24, 36, and 60 months - a clinical examination, a digital impression of the teeth known as "an intraoral scan" (Trios 3, 3Shape, Copenhagen, Denmark) and intraoral photographs. In addition, at 1, 6, and 12 months patients will be asked to fill out a Visual Analogue Scale (VAS) form regarding patient satisfaction Furthermore, we will investigate stability by superimposition (Orthoanalyzer, 3Shape, Copenhagen, Denmark) together with recording of adverse effects (i.e. any changes in torque and/or rotations of the teeth).
- Conditions
- Relapse
- Being tested
- Bonding of either CAD/CAM or conventional multistranded stainless steel fixed retainer
- Keywords
- Orthodontic retainer, relapse, stability, CAD/CAM, fixed retainer
- Medical subject headings
- Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bonding of either CAD/CAM or conventional multistranded stainless steel fixed retainerOther
Investigate and compare the clinical effectiveness of two types of fixed retainers; CAD/CAM vs. multistranded wire.
| Study group | Role | What they receive |
|---|---|---|
| CAD/CAM | Experimental | CAD/CAM custom-cut Nickel Titanium (NiTi) FR Receives: Other: Bonding of either CAD/CAM or conventional multistranded stainless steel fixed retainer |
| Conventional multistranded | Active comparator | Conventional multistranded Stainless Steel (SS) FR Receives: Other: Bonding of either CAD/CAM or conventional multistranded stainless steel fixed retainer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stability
Change in lower incisor crowding will be assessed using Little's Irregularity Index (LII). Change in overall occlusal stability will be assessed by the Peer Assessment Rating (PAR) index. In addition, changes in arch dimensions, occlusal relationships, and re-opening of extraction spaces will be recorded.
Measured: From debonding (T1), and after 6, 12, 24, 36 and 60 months in retention phase (T4, T5, T6, T7, and T8 respectively)
Secondary outcomes (4)
Failure rate and survival time
Calculated from the first day of retainer's bonding to the day of the first failure episode
Measured: From the time of retainer bonding to the first failure episode: From debonding, and up to 60 months later
Adverse effects
Screen for unexpected posttreatment changes in the mandibular anterior region associated with the use of both types of fixed retainers
Measured: From debonding, and up to 60 months later
Cost-effectiveness
Unit costs in euros (€) will be used to value the resources included
Measured: From debonding, and up to 60 months later
Patient satisfaction
Visual Analogue Scale (VAS)
Measured: From debonding, and after 1, 6 and 12 months in retention phase
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start1 Sep 2018
- Primary completionNov 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (26)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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Two-center randomized controlled clinical trial. Consecutive patients who are about to finish their fixed appliance orthodontic treatment at the two orthodontic departments will be screened for eligibility criteria. Eligible subjects will be randomized to have one of either two different fixed retainers to be bonded (to the upper and lower anterior teeth) by one operator in each center. Subjects will be allocated 1:1 into one of the two groups.
- Masking
- None (open label)
- Enrolment
- 126 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo
- Responsible party
- Sponsor
- Investigators
- Marie A Cornelis, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04389879
- Sponsor's protocol ID
- 01286
- Acronym
- Retention
- Status last verified
- Nov 2022
- First submitted
- 16 Apr 2020
- Last updated
- 3 Nov 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Owman G, Bjerklin K, Kurol J. Mandibular incisor stability after orthodontic treatment in the upper arch. Eur J Orthod. 1989 Nov;11(4):341-50. doi: 10.1093/oxfordjournals.ejo.a036005.
PubMed 2591482Al Yami EA, Kuijpers-Jagtman AM, van 't Hof MA. Stability of orthodontic treatment outcome: follow-up until 10 years postretention. Am J Orthod Dentofacial Orthop. 1999 Mar;115(3):300-4. doi: 10.1016/s0889-5406(99)70333-1.
PubMed 10066979Littlewood SJ, Millett DT, Doubleday B, Bearn DR, Worthington HV. Retention procedures for stabilising tooth position after treatment with orthodontic braces. Cochrane Database Syst Rev. 2004;(1):CD002283. doi: 10.1002/14651858.CD002283.pub2.
PubMed 14973985Reitan K. Clinical and histologic observations on tooth movement during and after orthodontic treatment. Am J Orthod. 1967 Oct;53(10):721-45. doi: 10.1016/0002-9416(67)90118-2. No abstract available.
PubMed 5233926Little RM, Wallen TR, Riedel RA. Stability and relapse of mandibular anterior alignment-first premolar extraction cases treated by traditional edgewise orthodontics. Am J Orthod. 1981 Oct;80(4):349-65. doi: 10.1016/0002-9416(81)90171-8.
PubMed 6945805Littlewood SJ, Millett DT, Doubleday B, Bearn DR, Worthington HV. Orthodontic retention: a systematic review. J Orthod. 2006 Sep;33(3):205-12. doi: 10.1179/146531205225021624.
PubMed 16926314Gardner SD, Chaconas SJ. Posttreatment and postretention changes following orthodontic therapy. Angle Orthod. 1976 Apr;46(2):151-61. doi: 10.1043/0003-3219(1976)0462.0.CO;2.
PubMed 1064343Goldberg AI, Behrents RG, Oliver DR, Buschang PH. Facial divergence and mandibular crowding in treated subjects. Angle Orthod. 2013 May;83(3):381-8. doi: 10.2319/061912-505.1. Epub 2012 Oct 18.
PubMed 23075061Artun J, Spadafora AT, Shapiro PA. A 3-year follow-up study of various types of orthodontic canine-to-canine retainers. Eur J Orthod. 1997 Oct;19(5):501-9. doi: 10.1093/ejo/19.5.501.
PubMed 9386336Bolla E, Cozzani M, Doldo T, Fontana M. Failure evaluation after a 6-year retention period: a comparison between glass fiber-reinforced (GFR) and multistranded bonded retainers. Int Orthod. 2012 Mar;10(1):16-28. doi: 10.1016/j.ortho.2011.12.005. Epub 2012 Jan 11. English, French.
PubMed 22240271Rose E, Frucht S, Jonas IE. Clinical comparison of a multistranded wire and a direct-bonded polyethylene ribbon-reinforced resin composite used for lingual retention. Quintessence Int. 2002 Sep;33(8):579-83.
PubMed 12238688Salehi P, Zarif Najafi H, Roeinpeikar SM. Comparison of survival time between two types of orthodontic fixed retainer: a prospective randomized clinical trial. Prog Orthod. 2013 Sep 11;14:25. doi: 10.1186/2196-1042-14-25.
PubMed 24326013Saleh M, Hajeer MY, Muessig D. Acceptability comparison between Hawley retainers and vacuum-formed retainers in orthodontic adult patients: a single-centre, randomized controlled trial. Eur J Orthod. 2017 Aug 1;39(4):453-461. doi: 10.1093/ejo/cjx024.
PubMed 28430890Hichens L, Rowland H, Williams A, Hollinghurst S, Ewings P, Clark S, Ireland A, Sandy J. Cost-effectiveness and patient satisfaction: Hawley and vacuum-formed retainers. Eur J Orthod. 2007 Aug;29(4):372-8. doi: 10.1093/ejo/cjm039.
PubMed 17702797Tynelius GE, Lilja-Karlander E, Petren S. A cost-minimization analysis of an RCT of three retention methods. Eur J Orthod. 2014 Aug;36(4):436-41. doi: 10.1093/ejo/cjt070. Epub 2013 Oct 1.
PubMed 24084630
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAD/CAM Fixed Retainers vs. Conventional Multistranded Fixed Retainers in Orthodontic Patients. Comparison of Stability, Retainer Failure Rate, Adverse Effects, Cost-effectiveness, and Patient Satisfaction. A Randomized Controlled Clinical Trial.
- ClinicalTrials.gov ID
- NCT04389879
- Acronym / sponsor ID
- Retention / 01286
- Conditions
- Relapse
- Keywords
- Orthodontic retainer, relapse, stability, CAD/CAM, fixed retainer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (estimated)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Collaborators
- University of Oslo
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 15 May 2020 (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.
Introduction:
Orthodontic retainers are used after the completion of orthodontic treatment to assure dental occlusal stability and to maintain the achieved end-result. However, without retention teeth could go back to their initial dental malposition or could even take a different unpredicted position resulting once again in dental malocclusion (a deviation from normal occlusion).
There are different types of retainers, some are fixed (glued to the back of the front teeth), and others are removable (can be removed and replaced into the mouth by the patient).
While there are various retainers used for retention (stability), there is no perfect method. Fixed retainers (FRs) are used worldwide. On the one hand, FRs focus on preventing relapse. On the other hand, there are sometimes some adverse effects of retainers; they could fail at a certain point (break/get loose), or cause unwanted tooth movements. Until now, the choice of a retention method is based solely on clinicians' experience as there is no substantial evidence regarding the best retention method or the duration of the retention period. Some clinicians prolong the retention period while others prefer to keep the retainers for an indefinite time.
As the world is advancing, so is the orthodontic science. New FR fabricated by CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing), are assumed to have greater accuracy, better fit, and most importantly, might offer a passive positioning of the retainer. However, the evidence about CAD/CAM FRs is very limited.
Purpose:
To investigate and compare the clinical effectiveness of two types of FRs; CAD/CAM vs. multistranded wire, in terms of stability (primary outcome), failure rate, adverse effects, cost-effectiveness, and patient satisfaction (secondary outcomes), substantial up to 5 years after retainer placement.
Hypotheses:
Compared to traditional multistranded FRs, CAD/CAM FRs have:
- Better long term stability,
- Similar failure rate,
- Fewer adverse effects,
- Similar cost-effectiveness and patient satisfaction.
Detailed description
Material and Methods
Setting: Section of Orthodontics, Department of Dentistry and Oral Health, Aarhus University, Denmark and Department of Orthodontics, Faculty of Dentistry, University of Oslo, Norway.
Sample size: 126 participants are needed for this study.
Randomization: After oral and written consent is obtained, allocation to groups, either conventional multistranded Stainless Steel fixed retainers, or CAD/CAM custom-cut Nickel Titanium fixed retainers, will take place at the last appointment before debonding. Subjects will be allocated 1:1 into one of the two groups.
Intervention protocol: After completing a full active orthodontic treatment, at both centers. The achieved treatment end result has to be maintained in the long term in order to prevent relapse (movement of teeth to the initial malocclusion). One of either two different fixed retainers will be bonded (to the upper and lower anterior teeth) by one operator in each center.
This study follows a standard retention protocol procedure carried at both centers and has a long term posttreatment follow-up of 5 years. Patients will be recalled for follow-up appointments after 1, 3, 6, 12, 24, 36 and 60 months. At follow-up visits, we will perform the following: at 1, and 3 months - a clinical examination. At 6, 12, 24, 36, and 60 months - a clinical examination, a digital impression of the teeth known as "an intraoral scan" (Trios 3, 3Shape, Copenhagen, Denmark) and intraoral photographs. In addition, at 1, 6, and 12 months patients will be asked to fill out a Visual Analogue Scale (VAS) form regarding patient satisfaction Furthermore, we will investigate stability by superimposition (Orthoanalyzer, 3Shape, Copenhagen, Denmark) together with recording of adverse effects (i.e. any changes in torque and/or rotations of the teeth).
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two-center randomized controlled clinical trial. Consecutive patients who are about to finish their fixed appliance orthodontic treatment at the two orthodontic departments will be screened for eligibility criteria. Eligible subjects will be randomized to have one of either two different fixed retainers to be bonded (to the upper and lower anterior teeth) by one operator in each center. Subjects will be allocated 1:1 into one of the two groups.
| Arm | Type | Receives |
|---|---|---|
| CAD/CAM | Experimental | Other: Bonding of either CAD/CAM or conventional multistranded stainless steel fixed retainerCAD/CAM custom-cut Nickel Titanium (NiTi) FR |
| Conventional multistranded | Active comparator | Other: Bonding of either CAD/CAM or conventional multistranded stainless steel fixed retainerConventional multistranded Stainless Steel (SS) FR |
Who may qualify
- Ages
- 12 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Healthy patients.
- Age: 12-25 years old (at time of debonding).
- Presence of all maxillary and mandibular anterior teeth, with normal shape and size.
- Completion of a course of fixed appliance therapy involving both dental arches.
- Subjects willing to consent to the trial and comply with the trial regime.
Key exclusion criteria (9 listed)
- Patients with cleft lip or palate, or both or any other craniofacial syndrome.
- Patients who had surgical correction of the jaws: Le fort I (2- or 3-piece maxilla) or SARPE (surgically assisted rapid palatal expansion).
- Lingual appliance treatments.
- Periodontal disease.
- Hypoplasia of enamel.
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 |
|---|---|---|
| Bonding of either CAD/CAM or conventional multistranded stainless steel fixed retainerInvestigate and compare the clinical effectiveness of two types of fixed retainers; CAD/CAM vs. multistranded wire. | Other | CAD/CAM, Conventional multistranded |
Primary outcome
Stability
Time frame: From debonding (T1), and after 6, 12, 24, 36 and 60 months in retention phase (T4, T5, T6, T7, and T8 respectively)
Change in lower incisor crowding will be assessed using Little's Irregularity Index (LII). Change in overall occlusal stability will be assessed by the Peer Assessment Rating (PAR) index. In addition, changes in arch dimensions, occlusal relationships, and re-opening of extraction spaces will be recorded.
4 secondary outcomes
Failure rate and survival time
Time frame: From the time of retainer bonding to the first failure episode: From debonding, and up to 60 months later
Adverse effects
Time frame: From debonding, and up to 60 months later
Cost-effectiveness
Time frame: From debonding, and up to 60 months later
Patient satisfaction
Time frame: From debonding, and after 1, 6 and 12 months in retention phase
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Nov 2022.
- Background: PubMed 2591482Owman G, Bjerklin K, Kurol J. Mandibular incisor stability after orthodontic treatment in the upper arch. Eur J Orthod. 1989 Nov;11(4):341-50. doi: 10.1093/oxfordjournals.ejo.a036005.
- Background: PubMed 10066979Al Yami EA, Kuijpers-Jagtman AM, van 't Hof MA. Stability of orthodontic treatment outcome: follow-up until 10 years postretention. Am J Orthod Dentofacial Orthop. 1999 Mar;115(3):300-4. doi: 10.1016/s0889-5406(99)70333-1.
- Background: PubMed 14973985Littlewood SJ, Millett DT, Doubleday B, Bearn DR, Worthington HV. Retention procedures for stabilising tooth position after treatment with orthodontic braces. Cochrane Database Syst Rev. 2004;(1):CD002283. doi: 10.1002/14651858.CD002283.pub2.
- Background: PubMed 5233926Reitan K. Clinical and histologic observations on tooth movement during and after orthodontic treatment. Am J Orthod. 1967 Oct;53(10):721-45. doi: 10.1016/0002-9416(67)90118-2. No abstract available.
- Background: PubMed 6945805Little RM, Wallen TR, Riedel RA. Stability and relapse of mandibular anterior alignment-first premolar extraction cases treated by traditional edgewise orthodontics. Am J Orthod. 1981 Oct;80(4):349-65. doi: 10.1016/0002-9416(81)90171-8.
- Background: PubMed 16926314Littlewood SJ, Millett DT, Doubleday B, Bearn DR, Worthington HV. Orthodontic retention: a systematic review. J Orthod. 2006 Sep;33(3):205-12. doi: 10.1179/146531205225021624.
- Background: PubMed 1064343Gardner SD, Chaconas SJ. Posttreatment and postretention changes following orthodontic therapy. Angle Orthod. 1976 Apr;46(2):151-61. doi: 10.1043/0003-3219(1976)0462.0.CO;2.
- Background: PubMed 23075061Goldberg AI, Behrents RG, Oliver DR, Buschang PH. Facial divergence and mandibular crowding in treated subjects. Angle Orthod. 2013 May;83(3):381-8. doi: 10.2319/061912-505.1. Epub 2012 Oct 18.
- Background: PubMed 9386336Artun J, Spadafora AT, Shapiro PA. A 3-year follow-up study of various types of orthodontic canine-to-canine retainers. Eur J Orthod. 1997 Oct;19(5):501-9. doi: 10.1093/ejo/19.5.501.
- Background: PubMed 22240271Bolla E, Cozzani M, Doldo T, Fontana M. Failure evaluation after a 6-year retention period: a comparison between glass fiber-reinforced (GFR) and multistranded bonded retainers. Int Orthod. 2012 Mar;10(1):16-28. doi: 10.1016/j.ortho.2011.12.005. Epub 2012 Jan 11. English, French.
- Background: PubMed 12238688Rose E, Frucht S, Jonas IE. Clinical comparison of a multistranded wire and a direct-bonded polyethylene ribbon-reinforced resin composite used for lingual retention. Quintessence Int. 2002 Sep;33(8):579-83.
- Background: PubMed 24326013Salehi P, Zarif Najafi H, Roeinpeikar SM. Comparison of survival time between two types of orthodontic fixed retainer: a prospective randomized clinical trial. Prog Orthod. 2013 Sep 11;14:25. doi: 10.1186/2196-1042-14-25.
- Individual participant dataSharing planned: No
Related trials for Relapse
RecruitingPhase 2
A Study to Evaluate the Efficacy of Cemsidomide + Dexamethasone in Participants With Relapsed/Refractory Multiple Myeloma
Multiple Myeloma, Relapsed/Refractory Multiple Myeloma
Active, not recruitingPhase 3
An Extension Study of Ublituximab in Participants With Relapsing Multiple Sclerosis
Relapsing Multiple Sclerosis (RMS)
RecruitingPhase 2/3
A Clinical Trial of MK-1045 in People With B-cell Acute Lymphoblastic Leukemia (MK-1045-005)
B-cell Acute Lymphoblastic Leukemia
RecruitingObservational study
A Long-term Follow-up Study of Patients With ARD103 CAR-T Cell Therapies
Acute Myeloid Leukemia, in Relapse, Acute Myeloid Leukemia, in Relapsed or Refractory
RecruitingObservational study
A Study Evaluating the Real World Experience of Participants Treated With BRIUMVI® (Ublituximab-xiiy) for Relapsing Multiple Sclerosis (RMS)
Relapsing Multiple Sclerosis, Multiple Sclerosis
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.
Marie A Cornelis principal investigator
University of Aarhus
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bonding of either CAD/CAM or conventional multistranded stainless steel fixed retainer in people with Relapse, run by University of Aarhus at 2 sites in 2 countries.
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 6 inclusion and 9 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: status not confirmed, as of the sponsor's last update on 3 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark, Norway. 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?
Results are not available in the source record.
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?
Stability (time frame: From debonding (T1), and after 6, 12, 24, 36 and 60 months in retention phase (T4, T5, T6, T7, and T8 respectively)). 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 NCT04389879, which also lists 26 linked publications.
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 Nov 2022.