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

August 8, 2022 updated by: Region Gävleborg

Vacuum-formed Retainer Versus Bonded Retainer to Prevent Relapse After Orthodontic Treatment - A Randomized Controlled Trial About Stability and Patients' Perceptions

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

104

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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
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.
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patients' Perception
Time Frame: 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
T4 (5 years follow up)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Gävleborg

Collaborators

Umeå University

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2009

Primary Completion (Actual)

January 14, 2021

Study Completion (Actual)

June 18, 2021

Study Registration Dates

First Submitted

February 28, 2017

First Submitted That Met QC Criteria

February 28, 2017

First Posted (Actual)

March 3, 2017

Study Record Updates

Last Update Posted (Actual)

August 9, 2022

Last Update Submitted That Met QC Criteria

August 8, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFUG-557411

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The participant data will be shared on reasonable request.

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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