Clinical trial NCT04616755: Stability of Maxillary Anterior Teeth After Two Years of Retention in Adolescents Comparing Two Bonded and a Vacuum-formed Retainer
Official title: Stability of Maxillary Anterior Teeth After Two Years of Retention in Adolescents - A Randomized Controlled Trial Comparing Two Bonded and a Vacuum-formed Retainer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Orthodontic Appliance Complication
Keywords: Retention devices
Relapse
Maxillary incisors
Irregularity
Lead sponsor: Kronoberg County Council
Sponsor class: OTHER_GOV
Collaborators: name: Malmö University
First posted: 2020-11-05
Enrollment: 90
Sex: ALL
Minimum age (years): 11
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three groups with different retention devices
Primary purpose: TREATMENT

Brief summary: After orthodontic treatment 3 different retention devices will be compared.Thirty patients in each group; Group 1) Bonded retainer 13-23, Group 2)Bonded retainer 12-22 and Group 3) Vacuum-formed retainer covering all erupted teeth in the maxilla. Retention capacity between these three devices will be compared after 2 years of retention by measuring Contact Point displacements (CPD) between 6 anterior teeth and sum of 5 anterior CPDs called Little´s Irregularity Index (LII).

Detailed description: Studies have shown that esthetics, no doubt, is the major motivating factor for orthodontic treatment both in adults and adolescents.Orthodontic relapses are usually described as changes toward the pretreatment status. These changes occur very fast if the teeth are not kept in their new position. That is the reason why, after orthodontic treatment, the result must be stabilized by some kind of retention device to prevent relapse. However, after this first period of remodeling of periodontal structures, comes the later period of changes.

Relapse in aesthetic zone (Anterior teeth), is the major reason why patients are dissatisfied with the results and seek for retreatment. There is a gap in our knowledge which kind of retention device is more effective to stabilize achieved alignment after orthodontic treatment.

This randomized clinical trial, tries to answer to that question. The investigators shall compare three different retention devices and measure changes after 2 years when retention devices have been in place and later compare the long-term results when the retainers have been removed after 2 years of retention (future study 5 years ptstretention).

Randomization Three months before the estimated removal of the fixed appliances, the patients will be invited to take part in the trial. After gaining informed consent from the patient and their custodians, the patients are randomly allocated to one of the three retention groups as follow: A) bonded retainer 13-23, B) bonded retainer 12-22 and C) removable vacuum-formed retainer (VFR) covering the maxillary teeth including the second molars. The randomization process is prepared by an independent person and carried out by three staff members not involved in the trial. The randomization uses blocks of 30. The randomization notes is delivered in a sealed opaque envelope each. Every new participant picked an envelope and reveal the group assignment by opening the envelope. Recruitment is ongoing until the total number of participants meet the estimated sample size.

Eligibility criteria: Inclusion Criteria:

* Young children age between 11 to 19 years old undergone orthodontic treatment.

Exclusion Criteria:

* Syndrome patients
* Skeletal discrepancy
* missing maxillary anterior teeth
* Adults

Primary outcomes:
measure: Changes in LII (sum of 5 contact point discrepancy)among 6 maxillary front teeth
timeFrame: 2 years after retention device in place
measure: Changes in CPD
timeFrame: 2 years after retention device in place
Secondary outcomes:
measure: Intercanine distance
timeFrame: 2 years after retention device in place
measure: Intermolar distance
timeFrame: 2 years after retention device in place
Other outcomes:
Locations:
Study officials:
References:
citation: Sonesson M, Naraghi S, Bondemark L. Cost analysis of two types of fixed maxillary retainers and a removable vacuum-formed maxillary retainer: a randomized controlled trial. Eur J Orthod. 2022 Mar 30;44(2):197-202. doi: 10.1093/ejo/cjab080.
citation: Naraghi S, Ganzer N, Bondemark L, Sonesson M. Stability of maxillary anterior teeth after 2 years of retention in adolescents: a randomized controlled trial comparing two bonded and a vacuum-formed retainer. Eur J Orthod. 2021 Apr 3;43(2):152-158. doi: 10.1093/ejo/cjaa077.