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

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).

Study Overview

• Status: Completed
• Conditions: Orthodontic Appliance Complication
• Intervention / Treatment: Other: 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.

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.

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Bonded retainer 13-23; This group have bonded retainer behind six front teeth in the maxilla to keep front teeth stable.	Other: 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; Other Names: Measuring changes of 5 single Contact point displacements in mm 2 years after retention have been I place.
Active Comparator: Bonded retainer 12-22; This group have bonded retainer behind four front teeth in the maxilla to keep front teeth stable.	Other: 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; Other Names: Measuring changes of 5 single Contact point displacements in mm 2 years after retention have been I place.
Active Comparator: Vacuum-formed retainer; This group have Vacuum-formed retainer covering all erupted teeth in maxilla to keep front teeth stable	Other: 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; Other Names: Measuring changes of 5 single Contact point displacements in mm 2 years after retention have been I place.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in LII (sum of 5 contact point discrepancy)among 6 maxillary front teeth	Sum of five single contact points of maxillary anterior teeth	2 years after retention device in place
Changes in CPD	Changes in single contact point discrepancy of five maxillary anterior teeth	2 years after retention device in place

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intercanine distance	Measuring the distance between top of the canines in maxilla	2 years after retention device in place
Intermolar distance	Measuring the distance between cusp tips of first molars	2 years after retention device in place

Collaborators and Investigators

• Sponsor: Kronoberg County Council
• Collaborators: Malmö University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2013
• Primary Completion (Actual): August 1, 2018
• Study Completion (Actual): August 1, 2020

Study Registration Dates

• First Submitted: October 23, 2020
• First Submitted That Met QC Criteria: October 29, 2020
• First Posted (Actual): November 5, 2020

Study Record Updates

• Last Update Posted (Actual): November 13, 2020
• Last Update Submitted That Met QC Criteria: November 10, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: Relapse; Retention devices; Maxillary incisors; Irregularity
• Other Study ID Numbers: Region Kronoberg

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No