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Vacuum-formed Retainer Versus Bonded Retainer to Prevent Relapse After Orthodontic Treatment

Primary Purpose

Orthodontics, Retention

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
CTC retainer
Essix retainer maxilla
Essix retainer mandible
Alginate impression
Questionnaire
Sponsored by
Region Gävleborg
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Orthodontics focused on measuring Essix retainer, Vacuum-formed retainer, Cuspid-to-cuspid retainer

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients treated with fixed appliances in both the maxilla and the mandible

Exclusion Criteria:

  • Rapid Maxillary Expansion (RME) for patients with severe transversal malocclusion
  • Treatment with segmented appliances
  • Patients with craniofacial anomalies and patients requiring orthognatic surgery
  • Patients with missing mandibular incisor

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Group A: CTC retainer + Essix retainer

    Group B: Essix retainer + Essix retainer

    Arm Description

    The CTC is bonded directly after debonding. The Essix retainer maxilla is handed out to the patient the same day after removal of fixed appliances. Alginate impressions are taken at the follow-up visits. Questionnaires are completed at the follow-up visits.

    The Essix retainer maxilla and Essix retainer mandible are handed out to the patient the same day after removal of fixed appliances. Alginate impressions are taken at the follow-up visits. Questionnaires are completed at the follow-up visits.

    Outcomes

    Primary Outcome Measures

    Changes in Tooth Position
    Analyses of changes in tooth position on dental casts Little's Irregularity Index (in mm) 0=no crowding/irregularity, higher scores= more crowding/irregularity (worse outcome)

    Secondary Outcome Measures

    Patients' Perception
    Analyses of patients' perception by validated self-report questionnaires to evaluate experiences of the retention techniques VAS (visual analog scale, 0-100) 0= low satisfaction 100= high satisfaction

    Full Information

    First Posted
    February 28, 2017
    Last Updated
    August 8, 2022
    Sponsor
    Region Gävleborg
    Collaborators
    Umeå University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03070444
    Brief Title
    Vacuum-formed Retainer Versus Bonded Retainer to Prevent Relapse After Orthodontic Treatment
    Official Title
    Vacuum-formed Retainer Versus Bonded Retainer to Prevent Relapse After Orthodontic Treatment - A Randomized Controlled Trial About Stability and Patients' Perceptions
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2022
    Overall Recruitment Status
    Completed
    Study Start Date
    November 12, 2009 (Actual)
    Primary Completion Date
    January 14, 2021 (Actual)
    Study Completion Date
    June 18, 2021 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Region Gävleborg
    Collaborators
    Umeå University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this trial is to evaluate and compare stability after orthodontic treatment with an Essix retainer and a bonded cuspid-to-cuspid retainer (CTC), respectively in the mandibular arch and longitudinally follow these patients over time up to 5 years. The patients' perceptions of the two methods are also evaluated with questionnaires during the follow-up period. A further aim of this study is to analyze the relationship between diagnosis, treatment outcome, treatment time, age at start of treatment and stability with an Essix retainer in the maxilla. The null hypotheses are: that there is no difference in retention capacity between Essix retainer and cuspid-to-cuspid retainer that there is no difference in patients' perception between Essix retainer and cuspid-to-cuspid retainer that there is no difference in retention capacity for Essix retainer in the maxilla concerning diagnosis before treatment, treatment outcomes, treatment time and age at start of treatment
    Detailed Description
    The study is conducted at the Orthodontic Clinic, Gävle, Sweden and consists of 104 patients. All patients are treated with fixed appliances in the upper and lower jaw (standard .022 straight wire), both with and without extractions. The patients are randomized into two groups with 52 patients in each group (Group A: cuspid-to-cuspid retainer, Group B: Essix retainer). Dental cast are obtained at the debond appointment (T1) and at the follow-up controls after six months (T2), 18 months (T3) and 60 months (T4) for both groups. At the visit two weeks in retention and at the follow-up visits after 6, 18 and 60 months the patients assess questionnaires in order to evaluate their experience of retention with the retention device.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Orthodontics, Retention
    Keywords
    Essix retainer, Vacuum-formed retainer, Cuspid-to-cuspid retainer

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    104 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A: CTC retainer + Essix retainer
    Arm Type
    Experimental
    Arm Description
    The CTC is bonded directly after debonding. The Essix retainer maxilla is handed out to the patient the same day after removal of fixed appliances. Alginate impressions are taken at the follow-up visits. Questionnaires are completed at the follow-up visits.
    Arm Title
    Group B: Essix retainer + Essix retainer
    Arm Type
    Active Comparator
    Arm Description
    The Essix retainer maxilla and Essix retainer mandible are handed out to the patient the same day after removal of fixed appliances. Alginate impressions are taken at the follow-up visits. Questionnaires are completed at the follow-up visits.
    Intervention Type
    Device
    Intervention Name(s)
    CTC retainer
    Other Intervention Name(s)
    Fixed retainer, Bonded retainer
    Intervention Description
    The CTC retainer consists of 0.8 hard Remanium® wire (Dentaurum, Germany) and is bonded with Tetric Flow (Ivoclar Vivadent, Liechtenstein) to the lower canines directly after debonding.
    Intervention Type
    Device
    Intervention Name(s)
    Essix retainer maxilla
    Other Intervention Name(s)
    Removable retainer, Vacuum-formed retainer
    Intervention Description
    The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances.
    Intervention Type
    Device
    Intervention Name(s)
    Essix retainer mandible
    Other Intervention Name(s)
    Removable retainer, Vacuum-formed retainer
    Intervention Description
    The Essix retainer is made of 1 mm Essix C+® Plastic (Dentsply, USA) and is handed out to the patient the same day after removal of fixed appliances.
    Intervention Type
    Procedure
    Intervention Name(s)
    Alginate impression
    Intervention Description
    Alginate impressions are taken to made the cuspid-to-cuspid and Essix retainers, respectively. Dental casts are obtained at the debond appointment and at the follow-up visits after 6, 18 and 60 months.
    Intervention Type
    Other
    Intervention Name(s)
    Questionnaire
    Intervention Description
    A questionnaire is completed at the follow-up visits.
    Primary Outcome Measure Information:
    Title
    Changes in Tooth Position
    Description
    Analyses of changes in tooth position on dental casts Little's Irregularity Index (in mm) 0=no crowding/irregularity, higher scores= more crowding/irregularity (worse outcome)
    Time Frame
    Changes in tooth position (Little's Irregularity Index) were analysed 5 years (T4) after debonding (T1)
    Secondary Outcome Measure Information:
    Title
    Patients' Perception
    Description
    Analyses of patients' perception by validated self-report questionnaires to evaluate experiences of the retention techniques VAS (visual analog scale, 0-100) 0= low satisfaction 100= high satisfaction
    Time Frame
    T4 (5 years follow up)

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Patients treated with fixed appliances in both the maxilla and the mandible Exclusion Criteria: Rapid Maxillary Expansion (RME) for patients with severe transversal malocclusion Treatment with segmented appliances Patients with craniofacial anomalies and patients requiring orthognatic surgery Patients with missing mandibular incisor
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Anke Krämer, DDS
    Organizational Affiliation
    Folktandvården Gävleborg AB, Specialisttandvården ortdonti
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    The participant data will be shared on reasonable request.
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    Vacuum-formed Retainer Versus Bonded Retainer to Prevent Relapse After Orthodontic Treatment

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