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

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ClinicalTrials.gov Identifier: NCT03070444
Recruitment Status : Active, not recruiting
First Posted : March 3, 2017
Last Update Posted : March 9, 2017
Sponsor:
Collaborators:
Umeå University
Department of Research and Development, County Council of Gavleborg and Uppsala University
Information provided by (Responsible Party):
Region Gävleborg

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 Not Applicable

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 Type : Interventional  (Clinical Trial)
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 : November 12, 2009
Estimated Primary Completion Date : June 10, 2021
Estimated Study Completion Date : June 10, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Orthodontia

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.




Primary Outcome Measures :
  1. Changes in tooth position [ Time Frame: T0 (start of orthodontic treatment), T1 (debonding/start of retention), T2 (6-months follow-up), T3 (18-months follow-up), T4 (60-months follow up) ]
    Analyses of tooth position T0, T1, T2, T3 and T4 on dental casts


Secondary Outcome Measures :
  1. Patients' perception [ Time Frame: T1 (debonding/start of retention), T2 (6-months follow-up), T3 (18-months follow-up), T4 (60-months follow up) ]
    Analyses of patients' perception by validated self-report questionnaires to evaluate their experiences of the retention techniques.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03070444


Sponsors and Collaborators
Region Gävleborg
Umeå University
Department of Research and Development, County Council of Gavleborg and Uppsala University
Investigators
Principal Investigator: Anke Krämer, DDS Folktandvården Gävleborg AB, Specialisttandvården ortdonti

Publications:

Responsible Party: Region Gävleborg
ClinicalTrials.gov Identifier: NCT03070444     History of Changes
Other Study ID Numbers: CFUG-557411
First Posted: March 3, 2017    Key Record Dates
Last Update Posted: March 9, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Region Gävleborg:
Essix retainer
Cuspid-to-cuspid retainer

Additional relevant MeSH terms:
Alginic acid
Hemostatics
Coagulants
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs