N/A N=104 Randomized Single-blind Treatment

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

Orthodontics · Retention

Bottom Line

View on ClinicalTrials.gov: NCT03070444 ↗

Enrolled (actual)

104

Serious AEs

0.0%

Results posted

Jun 2022

Primary outcome: Primary: Changes in Tooth Position — 0.05; 0.62 millimeters — p=0.0002

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: CTC retainer (Device); Essix retainer maxilla (Device); Essix retainer mandible (Device); Alginate impression (Procedure); Questionnaire (Other)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: Region Gävleborg
Primary completion: Jan 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Changes in Tooth Position	0.05; 0.62	0.0002 sig
SECONDARY Patients' Perception	93; 92	0.55

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

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03070444). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.