Vacuum-formed Retainer Versus Bonded Retainer to Prevent Relapse After Orthodontic Treatment
NCT ID: NCT03070444
Last Updated: 2022-08-09
Study Results
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View full resultsBasic Information
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COMPLETED
NA
104 participants
INTERVENTIONAL
2009-11-12
2021-06-18
Brief Summary
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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
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group A: CTC retainer + Essix retainer
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.
Questionnaire
A questionnaire is completed at the follow-up visits.
CTC 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 maxilla
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 impression
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.
Group B: Essix retainer + Essix retainer
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.
Questionnaire
A questionnaire is completed at the follow-up visits.
Essix retainer maxilla
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 mandible
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 impression
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.
Interventions
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Questionnaire
A questionnaire is completed at the follow-up visits.
CTC 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 maxilla
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 mandible
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 impression
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Treatment with segmented appliances
* Patients with craniofacial anomalies and patients requiring orthognatic surgery
* Patients with missing mandibular incisor
ALL
Yes
Sponsors
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Umeå University
OTHER
Region Gävleborg
OTHER
Responsible Party
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Principal Investigators
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Anke Krämer, DDS
Role: PRINCIPAL_INVESTIGATOR
Folktandvården Gävleborg AB, Specialisttandvården ortdonti
References
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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.
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.
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.
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.
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.
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.
Lindauer SJ, Shoff RC. Comparison of Essix and Hawley retainers. J Clin Orthod. 1998 Feb;32(2):95-7. No abstract available.
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.
Kumar AG, Bansal A. Effectiveness and acceptability of Essix and Begg retainers: a prospective study. Aust Orthod J. 2011 May;27(1):52-6.
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.
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.
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.
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.
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.
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.
Steegmans PAJ, Cavagnetto D, Reynders RAM. Which orthodontic retention protocol should I implement? A critical assessment of a randomised controlled trial. Evid Based Dent. 2022 Dec;23(4):162-165. doi: 10.1038/s41432-022-0845-7. Epub 2022 Dec 16.
Kramer A, Sjostrom M, Apelthun C, Hallman M, Feldmann I. Post-treatment stability after 5 years of retention with vacuum-formed and bonded retainers-a randomized controlled trial. Eur J Orthod. 2023 Feb 10;45(1):68-78. doi: 10.1093/ejo/cjac043.
Kramer A, Sjostrom M, Hallman M, Feldmann I. Vacuum-formed retainers and bonded retainers for dental stabilization-a randomized controlled trial. Part II: patients' perceptions 6 and 18 months after orthodontic treatment. Eur J Orthod. 2021 Apr 3;43(2):136-143. doi: 10.1093/ejo/cjaa039.
Kramer A, Sjostrom M, Hallman M, Feldmann I. Vacuum-formed retainer versus bonded retainer for dental stabilization in the mandible-a randomized controlled trial. Part I: retentive capacity 6 and 18 months after orthodontic treatment. Eur J Orthod. 2020 Nov 3;42(5):551-558. doi: 10.1093/ejo/cjz072.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CFUG-557411
Identifier Type: -
Identifier Source: org_study_id
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