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Completed

NCT Number: NCT03070444

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

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

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Key information

Conditions

Orthodontics Retention

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Fixed retainer, Bonded 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.

Other names: Removable retainer, Vacuum-formed 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.

Other names: Removable retainer, Vacuum-formed 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.

Questionnaire

Other

A questionnaire is completed at the follow-up visits.

Primary outcomes

  1. 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)

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Region Gävleborg

Other

Collaborators

  • Umeå University

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2021
Study completion
2021
First posted
Mar 3, 2017
Registry last updated
Aug 9, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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