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Clinical Trials/NCT04616755
NCT04616755
Completed
Not Applicable

Stability of Maxillary Anterior Teeth After Two Years of Retention in Adolescents - A Randomized Controlled Trial Comparing Two Bonded and a Vacuum-formed Retainer

Kronoberg County Council0 sites90 target enrollmentApril 2013

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Orthodontic Appliance Complication
Sponsor
Kronoberg County Council
Enrollment
90
Primary Endpoint
Changes in CPD
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 2013
End Date
August 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Kronoberg County Council
Responsible Party
Sponsor

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

Outcomes

Primary Outcomes

Changes in CPD

Time Frame: 2 years after retention device in place

Changes in single contact point discrepancy of five maxillary anterior teeth

Changes in LII (sum of 5 contact point discrepancy)among 6 maxillary front teeth

Time Frame: 2 years after retention device in place

Sum of five single contact points of maxillary anterior teeth

Secondary Outcomes

  • Intercanine distance(2 years after retention device in place)
  • Intermolar distance(2 years after retention device in place)

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