CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 104 enrolled
Drug / intervention
CTC retainer +4 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03070444
NCT03070444N/ACompleted

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

Region Gävleborg·interventional·Posted Mar 3, 2017·Updated Aug 9, 2022

In Brief

A clinical study evaluating CTC retainer, Essix retainer maxilla, and 3 other interventions for Orthodontics and Retention. Completed, enrolled 104 participants.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
CollaboratorsUmeå University

Timeline

N/ACompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedMar 3, 2017
Enrollment StartNov 12, 2009
Primary CompletionJan 14, 2021
Study CompletionJun 18, 2021
TodayJul 2, 2026
Enrollment to primary: 11.2 yearsPosted 9.3 years ago

Interventions

CTC retainerdevice

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 maxilladevice

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 mandibledevice

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 impressionprocedure

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.

Questionnaireother

A questionnaire is completed at the follow-up visits.