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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-04-30

Study Completion Date

2020-08-31

Brief Summary

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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

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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.

Conditions

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Orthodontic Appliance Complication

Keywords

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Retention devices Relapse Maxillary incisors Irregularity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Three groups with different retention devices

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

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

Study Groups

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Bonded retainer 13-23

This group have bonded retainer behind six front teeth in the maxilla to keep front teeth stable.

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

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

Bonded retainer 12-22

This group have bonded retainer behind four front teeth in the maxilla to keep front teeth stable.

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

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

Vacuum-formed retainer

This group have Vacuum-formed retainer covering all erupted teeth in maxilla to keep front teeth stable

Group Type ACTIVE_COMPARATOR

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

Intervention Type OTHER

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

Interventions

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Measuring 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

Intervention Type OTHER

Other Intervention Names

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Measuring changes of 5 single Contact point displacements in mm 2 years after retention have been I place.

Eligibility Criteria

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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

Minimum Eligible Age

11 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

References

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Naraghi S, Ganzer N, Bondemark L, Sonesson M. Stability of maxillary anterior teeth during retention and 1 year after removal of retention-an RCT on adolescents retained with two different bonded retainers and a vacuum-formed retainer. Eur J Orthod. 2023 Nov 30;45(6):629-636. doi: 10.1093/ejo/cjad020.

Reference Type DERIVED

PMID: 37119264 (View on PubMed)

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.

Reference Type DERIVED

PMID: 35021204 (View on PubMed)

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.

Reference Type DERIVED

PMID: 33351886 (View on PubMed)

Other Identifiers

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Region Kronoberg

Identifier Type: -

Identifier Source: org_study_id

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

Study Results

Basic Information

Brief Summary

Detailed Description

Conditions

Keywords

Study Design

Study Groups

Bonded retainer 13-23

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

Bonded retainer 12-22

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

Vacuum-formed retainer

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

Interventions

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

Other Intervention Names

Eligibility Criteria

Inclusion Criteria

Exclusion Criteria

Sponsors

Malmö University

Kronoberg County Council

Responsible Party

References

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.

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.

Other Identifiers

Region Kronoberg