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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04616755
Enrollment
90
Registered
2020-11-05
Start date
2013-04-30
Completion date
2020-08-31
Last updated
2020-11-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthodontic Appliance Complication

Keywords

Retention devices, Relapse, Maxillary incisors, Irregularity

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.

Interventions

OTHERMeasuring changes of Little´s irregularity index ( sum of 5 contact point discrepancies together) measured in mm 2 years after retention have been I place.

Measuring changes occurred under 2 years which the retention devices have been in place between the groups

Sponsors

Malmö University
CollaboratorOTHER
Kronoberg County Council
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

All study casts will be scanned without name just with a number and assessor do not know which group they belong to.

Intervention model description

Three groups with different retention devices

Eligibility

Sex/Gender
ALL
Age
11 Years to 19 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Changes in LII (sum of 5 contact point discrepancy)among 6 maxillary front teeth2 years after retention device in placeSum of five single contact points of maxillary anterior teeth
Changes in CPD2 years after retention device in placeChanges in single contact point discrepancy of five maxillary anterior teeth

Secondary

MeasureTime frameDescription
Intercanine distance2 years after retention device in placeMeasuring the distance between top of the canines in maxilla
Intermolar distance2 years after retention device in placeMeasuring the distance between cusp tips of first molars

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 17, 2026