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

• Sponsor: Region Gävleborg (Other)
• Overall Status: Completed
• CT.gov ID: NCT03070444
• Collaborator: Umeå University (Other)
• Enrollment: 104
• Arms: 2
• Actual Duration (Months): 139.2

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Orthodontics; Retention	Device: CTC retainer; Device: Essix retainer maxilla; Device: Essix retainer mandible; Procedure: Alginate impression; Other: Questionnaire	N/A

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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 104 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Vacuum-formed Retainer Versus Bonded Retainer to Prevent Relapse After Orthodontic Treatment - A Randomized Controlled Trial About Stability and Patients' Perceptions
• Actual Study Start Date: Nov 12, 2009
• Actual Primary Completion Date: Jan 14, 2021
• Actual Study Completion Date: Jun 18, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Device: 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.; Other Names: Fixed retainer Bonded retainer ; Device: 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.; Other Names: Removable retainer Vacuum-formed retainer ; Procedure: 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: Questionnaire; A questionnaire is completed at the follow-up visits.
Active Comparator: 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.	Device: 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.; Other Names: Removable retainer Vacuum-formed retainer ; Device: 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.; Other Names: Removable retainer Vacuum-formed retainer ; Procedure: 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: Questionnaire; A questionnaire is completed at the follow-up visits.

Outcome Measures

Primary Outcome Measures

1. Changes in Tooth Position [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)

Secondary Outcome Measures

1. Patients' Perception [T4 (5 years follow up)]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Region Gävleborg
• Umeå University

Investigators

• Principal Investigator: Anke Krämer, DDS, Folktandvården Gävleborg AB, Specialisttandvården ortdonti

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Jul 13, 2009

More Information

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.
• Bennett ME, Tulloch JF. Understanding orthodontic treatment satisfaction from the patients' perspective: a qualitative approach. Clin Orthod Res. 1999 May;2(2):53-61.
• 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.
• 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.
• 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.
• Jäderberg S, Feldmann I, Engström 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.
• Kumar AG, Bansal A. Effectiveness and acceptability of Essix and Begg retainers: a prospective study. Aust Orthod J. 2011 May;27(1):52-6.
• Lindauer SJ, Shoff RC. Comparison of Essix and Hawley retainers. J Clin Orthod. 1998 Feb;32(2):95-7.
• 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;(1):CD002283. doi: 10.1002/14651858.CD002283.pub4. Review.
• Reitan K. Clinical and histologic observations on tooth movement during and after orthodontic treatment. Am J Orthod. 1967 Oct;53(10):721-45.
• 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.
• Sheridan JJ, LeDoux W, McMinn R. Essix retainers: fabrication and supervision for permanent retention. J Clin Orthod. 1993 Jan;27(1):37-45.
• 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;(9):CD008734. doi: 10.1002/14651858.CD008734.pub2. Review.

• Responsible Party: Region Gävleborg
• ClinicalTrials.gov Identifier: NCT03070444
• Other Study ID Numbers: CFUG-557411
• First Posted: Mar 3, 2017
• Last Update Posted: Aug 9, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Region Gävleborg: Essix retainer; Vacuum-formed retainer; Cuspid-to-cuspid retainer
• Additional relevant MeSH terms: Recurrence

Study Results

Participant Flow

Arm/Group Title	Group A: CTC Retainer + Essix Retainer	Group B: Essix Retainer + Essix Retainer
Arm/Group Description	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. 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. Questionnaire: A questionnaire is completed at the follow-up visits.	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. 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. Questionnaire: A questionnaire is completed at the follow-up visits.
Period Title: Overall Study
STARTED	52	52
COMPLETED	39	35
NOT COMPLETED	13	17

Baseline Characteristics

Arm/Group Title	Group A: CTC Retainer + Essix Retainer	Group B: Essix Retainer + Essix Retainer	Total
Arm/Group Description	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. 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. Questionnaire: A questionnaire is completed at the follow-up visits.	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. 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. Questionnaire: A questionnaire is completed at the follow-up visits.	Total of all reporting groups
Overall Participants	52	52	104
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	17.1 (1.9)	17.1 (2.4)	17.1 (2.2)
Sex: Female, Male (Count of Participants)
Female	26 50%	26 50%	52 50%
Male	26 50%	26 50%	52 50%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	0 0%	0 0%	0 0%
Not Hispanic or Latino	0 0%	0 0%	0 0%
Unknown or Not Reported	52 100%	52 100%	104 100%
Region of Enrollment (participants) [Number]
Sweden	52 100%	52 100%	104 100%

Outcome Measures

1. Primary Outcome

Title	Changes in Tooth Position
Description	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)
Time Frame	Changes in tooth position (Little's Irregularity Index) were analysed 5 years (T4) after debonding (T1)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Group A: CTC Retainer + Essix Retainer	Group B: Essix Retainer + Essix Retainer
Arm/Group Description	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. 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. Questionnaire: A questionnaire is completed at the follow-up visits.	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. 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. Questionnaire: A questionnaire is completed at the follow-up visits.
Measure Participants	39	35
Median (Inter-Quartile Range) [millimeters]	0.05	0.62

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group A: CTC Retainer + Essix Retainer, Group B: Essix Retainer + Essix Retainer
	Comments
	Type of Statistical Test	Other
	Comments	GEE analysis
Statistical Test of Hypothesis	p-Value	0.0002
	Comments
	Method	GEE analysis
	Comments
Method of Estimation	Estimation Parameter	GEE analysis
	Estimated Value	0.99
	Confidence Interval	(2-Sided) 95%; 0.48 to 1.51
	Parameter Dispersion	Type: Value:
	Estimation Comments

2. Secondary Outcome

Title	Patients' Perception
Description	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
Time Frame	T4 (5 years follow up)

Outcome Measure Data

Analysis Population Description

Adolescent patients at debond (baseline), adults after 5 years

Arm/Group Title	Group A: CTC Retainer + Essix Retainer	Group B: Essix Retainer + Essix Retainer
Arm/Group Description	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. 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. Questionnaire: A questionnaire is completed at the follow-up visits.	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. 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. Questionnaire: A questionnaire is completed at the follow-up visits.
Measure Participants	39	35
Median (Inter-Quartile Range) [score on a scale]	93	92

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Group A: CTC Retainer + Essix Retainer, Group B: Essix Retainer + Essix Retainer
	Comments
	Type of Statistical Test	Other
	Comments	Mann-Whitney U test
Statistical Test of Hypothesis	p-Value	0.55
	Comments
	Method	Wilcoxon (Mann-Whitney)
	Comments

Adverse Events

Time Frame	Observation time: 5 years after debonding (T1-T4)
Arm/Group Title	Group A: CTC Retainer + Essix Retainer		Group B: Essix Retainer + Essix Retainer
Arm/Group Description	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. 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. Questionnaire: A questionnaire is completed at the follow-up visits.		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. 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. Questionnaire: A questionnaire is completed at the follow-up visits.
All Cause Mortality
	Group A: CTC Retainer + Essix Retainer		Group B: Essix Retainer + Essix Retainer
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/52 (0%)		0/52 (0%)
Serious Adverse Events
	Group A: CTC Retainer + Essix Retainer		Group B: Essix Retainer + Essix Retainer
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/52 (0%)		0/52 (0%)
Other (Not Including Serious) Adverse Events
	Group A: CTC Retainer + Essix Retainer		Group B: Essix Retainer + Essix Retainer
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/52 (0%)		0/52 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.