Clinical trial NCT03070444: Vacuum-formed Retainer Versus Bonded Retainer to Prevent Relapse After Orthodontic Treatment
Official title: Vacuum-formed Retainer Versus Bonded Retainer to Prevent Relapse After Orthodontic Treatment - A Randomized Controlled Trial About Stability and Patients' Perceptions
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthodontics
Retention
Keywords: Essix retainer
Vacuum-formed retainer
Cuspid-to-cuspid retainer
Lead sponsor: Region Gävleborg
Sponsor class: OTHER
Collaborators: name: Umeå University
First posted: 2017-03-03
Enrollment: 104
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

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.

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

Primary outcomes:
measure: Changes in Tooth Position
timeFrame: Changes in tooth position (Little's Irregularity Index) were analysed 5 years (T4) after debonding (T1)
Secondary outcomes:
measure: Patients' Perception
timeFrame: T4 (5 years follow up)
Other outcomes:
Locations:
Study officials:
affiliation: Folktandvården Gävleborg AB, Specialisttandvården ortdonti
name: Anke Krämer, DDS
role: PRINCIPAL_INVESTIGATOR
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