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

Orthodontic Appliance Complication Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04616755
• Other study ID #: Region Kronoberg
• Status: Completed
• Phase: N/A
• Start date: April 2013
• Est. completion date: August 2020

Study information

• Verified date: November 2020
• Source: Kronoberg County Council
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: August 2020
• Est. primary completion date: August 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 11 Years to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Orthodontic Appliance Complication

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Kronoberg County Council	Malmö University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Changes in CPD	Changes in single contact point discrepancy of five maxillary anterior teeth	2 years after retention device in place
Secondary	Intercanine distance	Measuring the distance between top of the canines in maxilla	2 years after retention device in place
Secondary	Intermolar distance	Measuring the distance between cusp tips of first molars	2 years after retention device in place