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

NCT03070444 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 104

Last updated 2022-08-09

Study results available
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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

Interventions

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.

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.

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.

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.

Sponsors & Collaborators

  • Umeå University

    collaborator OTHER

  • Region Gävleborg

    lead OTHER

Principal Investigators

  • Anke Krämer, DDS · Folktandvården Gävleborg AB, Specialisttandvården ortdonti

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-11-12
Primary Completion
2021-01-14
Completion
2021-06-18

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03070444 on ClinicalTrials.gov