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

Sponsor
Kronoberg County Council (Other)
Overall Status
Completed
CT.gov ID
NCT04616755
Collaborator
Malmö University (Other)
90
3
88

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase
  • 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.
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
90 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Three groups with different retention devicesThree groups with different retention devices
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.
Primary Purpose:
Treatment
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
Actual Study Start Date :
Apr 1, 2013
Actual Primary Completion Date :
Aug 1, 2018
Actual Study Completion Date :
Aug 1, 2020

Arms and Interventions

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.
  • Outcome Measures

    Primary Outcome Measures

    1. Changes in LII (sum of 5 contact point discrepancy)among 6 maxillary front teeth [2 years after retention device in place]

      Sum of five single contact points of maxillary anterior teeth

    2. Changes in CPD [2 years after retention device in place]

      Changes in single contact point discrepancy of five maxillary anterior teeth

    Secondary Outcome Measures

    1. Intercanine distance [2 years after retention device in place]

      Measuring the distance between top of the canines in maxilla

    2. Intermolar distance [2 years after retention device in place]

      Measuring the distance between cusp tips of first molars

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    11 Years to 19 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Kronoberg County Council
    • Malmö University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kronoberg County Council
    ClinicalTrials.gov Identifier:
    NCT04616755
    Other Study ID Numbers:
    • Region Kronoberg
    First Posted:
    Nov 5, 2020
    Last Update Posted:
    Nov 13, 2020
    Last Verified:
    Nov 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Kronoberg County Council

    Study Results

    No Results Posted as of Nov 13, 2020