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

NCT03070444 | Completed Results

• 1 other identifier: CFUG-557411
• Study Type: interventional
• Target: 104
• Locations: 0 countries
• Sites: N/A

Brief 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. The patients' perceptions of the two methods are also evaluated with questionnaires during the follow-up period. 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

Conditions

Orthodontics; Retention

Keywords

Essix retainer; Vacuum-formed retainer; Cuspid-to-cuspid retainer

Outcome Measures

Primary Outcomes (1)

• 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)

  Changes in tooth position (Little's Irregularity Index) were analysed 5 years (T4) after debonding (T1)

Secondary Outcomes (1)

• Patients' Perception

  T4 (5 years follow up)

Study Arms (2)

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.

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.

Device: Essix retainer maxilla; Device: Essix retainer mandible; Procedure: Alginate impression; Other: Questionnaire

Interventions

CTC retainer DEVICE

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.

Also known as: Fixed retainer, Bonded retainer

Group A: CTC retainer + Essix retainer

Essix retainer maxilla DEVICE

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.

Also known as: Removable retainer, Vacuum-formed retainer

Group A: CTC retainer + Essix retainer; Group B: Essix retainer + Essix retainer

Essix retainer mandible DEVICE

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.

Also known as: Removable retainer, Vacuum-formed retainer

Group B: Essix retainer + Essix retainer

Alginate impression PROCEDURE

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 A: CTC retainer + Essix retainer; Group B: Essix retainer + Essix retainer

Questionnaire OTHER

A questionnaire is completed at the follow-up visits.

Group A: CTC retainer + Essix retainer; Group B: Essix retainer + Essix retainer

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Region Gävleborg: lead
• Umeå University: collaborator

Related Publications (19)

• 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.

  PMID: 18004927 BACKGROUND

• 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.

  PMID: 10534980 BACKGROUND

• 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.

  PMID: 17319767 BACKGROUND

• 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.

  PMID: 21300723 BACKGROUND

• 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.

  PMID: 17702797 BACKGROUND

• 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.

  PMID: 21508267 BACKGROUND

• Lindauer SJ, Shoff RC. Comparison of Essix and Hawley retainers. J Clin Orthod. 1998 Feb;32(2):95-7. No abstract available.

  PMID: 9709631 BACKGROUND

• 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.

  PMID: 26824885 BACKGROUND

• Kumar AG, Bansal A. Effectiveness and acceptability of Essix and Begg retainers: a prospective study. Aust Orthod J. 2011 May;27(1):52-6.

  PMID: 21696115 BACKGROUND

• 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.

  PMID: 5233926 BACKGROUND

• 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.

  PMID: 18675196 BACKGROUND

• 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.

  PMID: 18068589 BACKGROUND

• 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.

  PMID: 8478438 BACKGROUND

• 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.

  PMID: 19828592 BACKGROUND

• 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.

  PMID: 24014170 BACKGROUND

• 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.

  PMID: 36526846 DERIVED

• 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.

  PMID: 35968668 DERIVED

• 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.

  PMID: 32613244 DERIVED

• 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.

  PMID: 31665279 DERIVED

MeSH Terms

Interventions

Orthodontic Appliances, Fixed; Surveys and Questionnaires

Intervention Hierarchy (Ancestors)

Orthodontic Appliances; Orthodontics; Dentistry; Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: Anke Krämer
• Organization: Folktandvården Gävleborg AB

anke.kramer@regiongavleborg.se

+4625155680

Study Officials

• Anke Krämer, DDS

  Folktandvården Gävleborg AB, Specialisttandvården ortdonti

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 28, 2017
• First Posted: March 3, 2017
• Study Start: November 12, 2009
• Primary Completion: January 14, 2021
• Study Completion: June 18, 2021
• Last Updated: August 9, 2022
• Results First Posted: June 8, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share