OrthodonticsNCT03070444

Vacuum-formed Retainer Versus Bonded Retainer to Prevent Relapse After Orthodontic Treatment

A study testing CTC retainer, Essix retainer maxilla and Essix retainer mandible in people with Orthodontics and Retention, run by Region Gävleborg.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The purpose of this trial is to evaluate and compare stability after orthodontic treatment with an Essix retainer and a bonded cuspid-to-cuspid retainer (CTC), respectively in the mandibular arch and longitudinally follow these patients over time up to 5 years. Read more about this study

Who is it for?: Any ageHealthy volunteers can take part
Conditions the study is for: Orthodontics, Retention
What is being tested?: CTC retainer, Essix retainer maxilla and Essix retainer mandible
Type of treatment: Medical device, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 104 participants
Where: No sites listed yet
Study dates: 12 Nov 2009to 18 Jun 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Any age
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Patients treated with fixed appliances in both the maxilla and the mandible

Who cannot join

Rapid Maxillary Expansion (RME) for patients with severe transversal malocclusion
Treatment with segmented appliances
Patients with craniofacial anomalies and patients requiring orthognatic surgery
Patients with missing mandibular incisor

About this study

Official title: Vacuum-formed Retainer Versus Bonded Retainer to Prevent Relapse After Orthodontic Treatment - A Randomized Controlled Trial About Stability and Patients' Perceptions

A further aim of this study is to analyze the relationship between diagnosis, treatment outcome, treatment time, age at start of treatment and stability with an Essix retainer in the maxilla.

The null hypotheses are:

that there is no difference in retention capacity between Essix retainer and cuspid-to-cuspid retainer
that there is no difference in patients' perception between Essix retainer and cuspid-to-cuspid retainer
that there is no difference in retention capacity for Essix retainer in the maxilla concerning diagnosis before treatment, treatment outcomes, treatment time and age at start of treatment

Read the detailed description

The study is conducted at the Orthodontic Clinic, Gävle, Sweden and consists of 104 patients. All patients are treated with fixed appliances in the upper and lower jaw (standard .022 straight wire), both with and without extractions. The patients are randomized into two groups with 52 patients in each group (Group A: cuspid-to-cuspid retainer, Group B: Essix retainer).

Dental cast are obtained at the debond appointment (T1) and at the follow-up controls after six months (T2), 18 months (T3) and 60 months (T4) for both groups.

At the visit two weeks in retention and at the follow-up visits after 6, 18 and 60 months the patients assess questionnaires in order to evaluate their experience of retention with the retention device.

Conditions: Orthodontics, Retention
Being tested: CTC retainer, Essix retainer maxilla, Essix retainer mandible, Alginate impression, Questionnaire
Keywords: Essix retainer, Vacuum-formed retainer, Cuspid-to-cuspid retainer

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

CTC retainerDevice
Also called Fixed retainer, Bonded retainer
The CTC retainer consists of 0.8 hard Remanium® wire (Dentaurum, Germany) and is bonded with Tetric Flow (Ivoclar Vivadent, Liechtenstein) to the lower canines directly after debonding.
Essix retainer maxillaDevice
Also called Removable retainer, Vacuum-formed retainer
The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances.
Essix retainer mandibleDevice
Also called Removable retainer, Vacuum-formed retainer
The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances.
Alginate impressionProcedure or surgery
Alginate impressions are taken to made the cuspid-to-cuspid and Essix retainers, respectively. Dental casts are obtained at the debond appointment and at the follow-up visits after 6, 18 and 60 months.
QuestionnaireOther
A questionnaire is completed at the follow-up visits.

Study groups in NCT03070444
Study group	Role	What they receive
Group A: CTC retainer + Essix retainer	Experimental	The CTC is bonded directly after debonding. The Essix retainer maxilla is handed out to the patient the same day after removal of fixed appliances. Alginate impressions are taken at the follow-up visits. Questionnaires are completed at the follow-up visits. Receives: Device: CTC retainer; Device: Essix retainer maxilla; Procedure: Alginate impression; Other: Questionnaire
Group B: Essix retainer + Essix retainer	Active comparator	The Essix retainer maxilla and Essix retainer mandible are handed out to the patient the same day after removal of fixed appliances. Alginate impressions are taken at the follow-up visits. Questionnaires are completed at the follow-up visits. Receives: Device: Essix retainer maxilla; Device: Essix retainer mandible; Procedure: Alginate impression; Other: Questionnaire

What is being measured

The primary outcome is the main question the study is designed to answer.

Changes in Tooth Position
Analyses of changes in tooth position on dental casts Little's Irregularity Index (in mm) 0=no crowding/irregularity, higher scores= more crowding/irregularity (worse outcome)
Measured: Changes in tooth position (Little's Irregularity Index) were analysed 5 years (T4) after debonding (T1)

Secondary outcomes (1)

Patients' Perception
Analyses of patients' perception by validated self-report questionnaires to evaluate experiences of the retention techniques VAS (visual analog scale, 0-100) 0= low satisfaction 100= high satisfaction
Measured: T4 (5 years follow up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

12 Nov 200918 Jun 2021

First posted3 Mar 2017
Study start12 Nov 2009
Primary completion14 Jan 2021
Study completion18 Jun 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (19)Papers the sponsor has linked to this study.
Other trials for OrthodonticsStudies 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: Single blind
Who is masked: Outcomes assessor
Enrolment: 104 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03070444
Sponsor's protocol ID: CFUG-557411
Status last verified: Aug 2022
First submitted: 28 Feb 2017
Last updated: 9 Aug 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: The participant data will be shared on reasonable request.

Publications

Atack N, Harradine N, Sandy JR, Ireland AJ. Which way forward? Fixed or removable lower retainers. Angle Orthod. 2007 Nov;77(6):954-9. doi: 10.2319/103106-449.1.
PubMed 18004927
Bennett ME, Tulloch JF. Understanding orthodontic treatment satisfaction from the patients' perspective: a qualitative approach. Clin Orthod Res. 1999 May;2(2):53-61. doi: 10.1111/ocr.1999.2.2.53.
PubMed 10534980
Feldmann I, List T, John MT, Bondemark L. Reliability of a questionnaire assessing experiences of adolescents in orthodontic treatment. Angle Orthod. 2007 Mar;77(2):311-7. doi: 10.2319/0003-3219(2007)077[0311:ROAQAE]2.0.CO;2.
PubMed 17319767
Feldmann I, List T, Bondemark L. Orthodontic anchoring techniques and its influence on pain, discomfort, and jaw function--a randomized controlled trial. Eur J Orthod. 2012 Feb;34(1):102-8. doi: 10.1093/ejo/cjq171. Epub 2011 Feb 7.
PubMed 21300723
Hichens 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 17702797
Jaderberg S, Feldmann I, Engstrom C. Removable thermoplastic appliances as orthodontic retainers--a prospective study of different wear regimens. Eur J Orthod. 2012 Aug;34(4):475-9. doi: 10.1093/ejo/cjr040. Epub 2011 Apr 20.
PubMed 21508267
Lindauer SJ, Shoff RC. Comparison of Essix and Hawley retainers. J Clin Orthod. 1998 Feb;32(2):95-7. No abstract available.
PubMed 9709631
Littlewood SJ, Millett DT, Doubleday B, Bearn DR, Worthington HV. Retention procedures for stabilising tooth position after treatment with orthodontic braces. Cochrane Database Syst Rev. 2016 Jan 29;2016(1):CD002283. doi: 10.1002/14651858.CD002283.pub4.
PubMed 26824885
Kumar AG, Bansal A. Effectiveness and acceptability of Essix and Begg retainers: a prospective study. Aust Orthod J. 2011 May;27(1):52-6.
PubMed 21696115
Reitan 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 5233926
Renkema AM, Al-Assad S, Bronkhorst E, Weindel S, Katsaros C, Lisson JA. Effectiveness of lingual retainers bonded to the canines in preventing mandibular incisor relapse. Am J Orthod Dentofacial Orthop. 2008 Aug;134(2):179e1-8. doi: 10.1016/j.ajodo.2008.06.003.
PubMed 18675196
Rowland H, Hichens L, Williams A, Hills D, Killingback N, Ewings P, Clark S, Ireland AJ, Sandy JR. The effectiveness of Hawley and vacuum-formed retainers: a single-center randomized controlled trial. Am J Orthod Dentofacial Orthop. 2007 Dec;132(6):730-7. doi: 10.1016/j.ajodo.2006.06.019.
PubMed 18068589
Sheridan JJ, LeDoux W, McMinn R. Essix retainers: fabrication and supervision for permanent retention. J Clin Orthod. 1993 Jan;27(1):37-45. No abstract available.
PubMed 8478438
Thickett E, Power S. A randomized clinical trial of thermoplastic retainer wear. Eur J Orthod. 2010 Feb;32(1):1-5. doi: 10.1093/ejo/cjp061. Epub 2009 Oct 14.
PubMed 19828592
Yu Y, Sun J, Lai W, Wu T, Koshy S, Shi Z. Interventions for managing relapse of the lower front teeth after orthodontic treatment. Cochrane Database Syst Rev. 2013 Sep 6;2013(9):CD008734. doi: 10.1002/14651858.CD008734.pub2.
PubMed 24014170

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Orthodontics trials

Study at a glance

From the registry record, last updated by the sponsor on 9 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Vacuum-formed Retainer Versus Bonded Retainer to Prevent Relapse After Orthodontic Treatment - A Randomized Controlled Trial About Stability and Patients' Perceptions
ClinicalTrials.gov ID: NCT03070444
Acronym / sponsor ID: CFUG-557411
Conditions: Orthodontics, Retention
Keywords: Essix retainer, Vacuum-formed retainer, Cuspid-to-cuspid retainer
Study type: Interventional
Recruitment status: Completed
Enrolment: 104 participants (actual)
Lead sponsor: Region GävleborgUniversity, hospital or other
Collaborators: Umeå University
Study start: 12 Nov 2009 (actual)
Primary completion: 14 Jan 2021 (actual)
Study completion: 18 Jun 2021 (actual)
First posted: 3 Mar 2017 (actual)
Results: Posted 8 Jun 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

A further aim of this study is to analyze the relationship between diagnosis, treatment outcome, treatment time, age at start of treatment and stability with an Essix retainer in the maxilla.

The null hypotheses are:

that there is no difference in retention capacity between Essix retainer and cuspid-to-cuspid retainer
that there is no difference in patients' perception between Essix retainer and cuspid-to-cuspid retainer
that there is no difference in retention capacity for Essix retainer in the maxilla concerning diagnosis before treatment, treatment outcomes, treatment time and age at start of treatment

Detailed description

Dental cast are obtained at the debond appointment (T1) and at the follow-up controls after six months (T2), 18 months (T3) and 60 months (T4) for both groups.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Group A: CTC retainer + Essix retainer	Experimental	Device: CTC retainer, Device: Essix retainer maxilla, Procedure: Alginate impression, Other: QuestionnaireThe CTC is bonded directly after debonding. The Essix retainer maxilla is handed out to the patient the same day after removal of fixed appliances. Alginate impressions are taken at the follow-up visits. Questionnaires are completed at the follow-up visits.
Group B: Essix retainer + Essix retainer	Active comparator	Device: Essix retainer maxilla, Device: Essix retainer mandible, Procedure: Alginate impression, Other: QuestionnaireThe Essix retainer maxilla and Essix retainer mandible are handed out to the patient the same day after removal of fixed appliances. Alginate impressions are taken at the follow-up visits. Questionnaires are completed at the follow-up visits.

Who may qualify

Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

Patients treated with fixed appliances in both the maxilla and the mandible

Key exclusion criteria (4 listed)

Rapid Maxillary Expansion (RME) for patients with severe transversal malocclusion
Treatment with segmented appliances
Patients with craniofacial anomalies and patients requiring orthognatic surgery
Patients with missing mandibular incisor

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
CTC retainerAlso: Fixed retainer, Bonded retainerThe CTC retainer consists of 0.8 hard Remanium® wire (Dentaurum, Germany) and is bonded with Tetric Flow (Ivoclar Vivadent, Liechtenstein) to the lower canines directly after debonding.	Device	Group A: CTC retainer + Essix retainer
Essix retainer maxillaAlso: Removable retainer, Vacuum-formed retainerThe Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances.	Device	Group A: CTC retainer + Essix retainer, Group B: Essix retainer + Essix retainer
Essix retainer mandibleAlso: Removable retainer, Vacuum-formed retainerThe Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances.	Device	Group B: Essix retainer + Essix retainer
Alginate impressionAlginate impressions are taken to made the cuspid-to-cuspid and Essix retainers, respectively. Dental casts are obtained at the debond appointment and at the follow-up visits after 6, 18 and 60 months.	Procedure or surgery	Group A: CTC retainer + Essix retainer, Group B: Essix retainer + Essix retainer
QuestionnaireA questionnaire is completed at the follow-up visits.	Other	Group A: CTC retainer + Essix retainer, Group B: Essix retainer + Essix retainer

Primary outcome

Changes in Tooth Position
Time frame: Changes in tooth position (Little's Irregularity Index) were analysed 5 years (T4) after debonding (T1)
Analyses of changes in tooth position on dental casts Little's Irregularity Index (in mm) 0=no crowding/irregularity, higher scores= more crowding/irregularity (worse outcome)

1 secondary outcome

Patients' Perception
Time frame: T4 (5 years follow up)

Results and safety

Results posted to the registry on 8 Jun 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Group A: CTC Retainer + Essix Retainer	52	39
Group B: Essix Retainer + Essix Retainer	52	35

Primary outcome: Changes in Tooth Position

Time frame: Changes in tooth position (Little's Irregularity Index) were analysed 5 years (T4) after debonding (T1). Median (Inter-Quartile Range). Unit: millimeters

Measure	Group A: CTC Retainer + Essix Retainer n = 39	Group B: Essix Retainer + Essix Retainer n = 35
Value	0.05 (-0.40 to 0.73)	0.62 (-0.08 to 1.49)

Group A: CTC Retainer + Essix Retainer vs Group B: Essix Retainer + Essix Retainer: GEE analysis: 0.99 (95% CI 0.48 to 1.51), p = 0.0002, GEE analysis

Population analysed: Dental casts were analysed. As data were not normal distributed, median values are reported.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Observation time: 5 years after debonding (T1-T4). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Group A: CTC Retainer + Essix Retainer	0 of 52 (0%)	0 of 52 (0%)	0 of 52
Group B: Essix Retainer + Essix Retainer	0 of 52 (0%)	0 of 52 (0%)	0 of 52

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 18004927Atack N, Harradine N, Sandy JR, Ireland AJ. Which way forward? Fixed or removable lower retainers. Angle Orthod. 2007 Nov;77(6):954-9. doi: 10.2319/103106-449.1.
Background: PubMed 10534980Bennett ME, Tulloch JF. Understanding orthodontic treatment satisfaction from the patients' perspective: a qualitative approach. Clin Orthod Res. 1999 May;2(2):53-61. doi: 10.1111/ocr.1999.2.2.53.
Background: PubMed 17319767Feldmann I, List T, John MT, Bondemark L. Reliability of a questionnaire assessing experiences of adolescents in orthodontic treatment. Angle Orthod. 2007 Mar;77(2):311-7. doi: 10.2319/0003-3219(2007)077[0311:ROAQAE]2.0.CO;2.
Background: PubMed 21300723Feldmann I, List T, Bondemark L. Orthodontic anchoring techniques and its influence on pain, discomfort, and jaw function--a randomized controlled trial. Eur J Orthod. 2012 Feb;34(1):102-8. doi: 10.1093/ejo/cjq171. Epub 2011 Feb 7.
Background: PubMed 17702797Hichens 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.
Background: PubMed 21508267Jaderberg S, Feldmann I, Engstrom C. Removable thermoplastic appliances as orthodontic retainers--a prospective study of different wear regimens. Eur J Orthod. 2012 Aug;34(4):475-9. doi: 10.1093/ejo/cjr040. Epub 2011 Apr 20.
Background: PubMed 9709631Lindauer SJ, Shoff RC. Comparison of Essix and Hawley retainers. J Clin Orthod. 1998 Feb;32(2):95-7. No abstract available.
Background: PubMed 26824885Littlewood SJ, Millett DT, Doubleday B, Bearn DR, Worthington HV. Retention procedures for stabilising tooth position after treatment with orthodontic braces. Cochrane Database Syst Rev. 2016 Jan 29;2016(1):CD002283. doi: 10.1002/14651858.CD002283.pub4.
Background: PubMed 21696115Kumar AG, Bansal A. Effectiveness and acceptability of Essix and Begg retainers: a prospective study. Aust Orthod J. 2011 May;27(1):52-6.
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 18675196Renkema AM, Al-Assad S, Bronkhorst E, Weindel S, Katsaros C, Lisson JA. Effectiveness of lingual retainers bonded to the canines in preventing mandibular incisor relapse. Am J Orthod Dentofacial Orthop. 2008 Aug;134(2):179e1-8. doi: 10.1016/j.ajodo.2008.06.003.
Background: PubMed 18068589Rowland H, Hichens L, Williams A, Hills D, Killingback N, Ewings P, Clark S, Ireland AJ, Sandy JR. The effectiveness of Hawley and vacuum-formed retainers: a single-center randomized controlled trial. Am J Orthod Dentofacial Orthop. 2007 Dec;132(6):730-7. doi: 10.1016/j.ajodo.2006.06.019.
Individual participant dataSharing planned: No. The participant data will be shared on reasonable request.

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Active, not recruitingObservational study
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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.

Anke Krämer, DDS principal investigator

Folktandvården Gävleborg AB, Specialisttandvården ortdonti

Questions about this trial

What is this clinical trial studying?

A study testing CTC retainer, Essix retainer maxilla and Essix retainer mandible in people with Orthodontics and Retention, run by Region Gävleborg.

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 1 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 9 Aug 2022. 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?

Yes. Results are posted in the registry (first posted 8 Jun 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Changes in Tooth Position (time frame: Changes in tooth position (Little's Irregularity Index) were analysed 5 years (T4) after debonding (T1)). 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 NCT03070444, which also lists 19 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 9 Aug 2022.