CAD/CAM Fixed Retainers vs. Conventional Multistranded Fixed Retainers in Orthodontic Patients. Comparison of Stability, Retainer Failure Rate, Adverse Effects, Cost-effectiveness, and Patient Satisfaction. A Randomized Controlled Clinical Trial (Retention)

November 2, 2022 updated by: University of Aarhus

CAD/CAM Fixed Retainers vs. Conventional Multistranded Fixed Retainers in Orthodontic Patients. Comparison of Stability, Retainer Failure Rate, Adverse Effects, Cost-effectiveness, and Patient Satisfaction. A Randomized Controlled Clinical Trial.

Introduction:

Orthodontic retainers are used after the completion of orthodontic treatment to assure dental occlusal stability and to maintain the achieved end-result. However, without retention teeth could go back to their initial dental malposition or could even take a different unpredicted position resulting once again in dental malocclusion (a deviation from normal occlusion).

There are different types of retainers, some are fixed (glued to the back of the front teeth), and others are removable (can be removed and replaced into the mouth by the patient).

While there are various retainers used for retention (stability), there is no perfect method. Fixed retainers (FRs) are used worldwide. On the one hand, FRs focus on preventing relapse. On the other hand, there are sometimes some adverse effects of retainers; they could fail at a certain point (break/get loose), or cause unwanted tooth movements. Until now, the choice of a retention method is based solely on clinicians' experience as there is no substantial evidence regarding the best retention method or the duration of the retention period. Some clinicians prolong the retention period while others prefer to keep the retainers for an indefinite time.

As the world is advancing, so is the orthodontic science. New FR fabricated by CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing), are assumed to have greater accuracy, better fit, and most importantly, might offer a passive positioning of the retainer. However, the evidence about CAD/CAM FRs is very limited.

Purpose:

To investigate and compare the clinical effectiveness of two types of FRs; CAD/CAM vs. multistranded wire, in terms of stability (primary outcome), failure rate, adverse effects, cost-effectiveness, and patient satisfaction (secondary outcomes), substantial up to 5 years after retainer placement.

Hypotheses:

Compared to traditional multistranded FRs, CAD/CAM FRs have:

  • Better long term stability,
  • Similar failure rate,
  • Fewer adverse effects,
  • Similar cost-effectiveness and patient satisfaction.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Material and Methods

Setting: Section of Orthodontics, Department of Dentistry and Oral Health, Aarhus University, Denmark and Department of Orthodontics, Faculty of Dentistry, University of Oslo, Norway.

Sample size: 126 participants are needed for this study.

Randomization: After oral and written consent is obtained, allocation to groups, either conventional multistranded Stainless Steel fixed retainers, or CAD/CAM custom-cut Nickel Titanium fixed retainers, will take place at the last appointment before debonding. Subjects will be allocated 1:1 into one of the two groups.

Intervention protocol: After completing a full active orthodontic treatment, at both centers. The achieved treatment end result has to be maintained in the long term in order to prevent relapse (movement of teeth to the initial malocclusion). One of either two different fixed retainers will be bonded (to the upper and lower anterior teeth) by one operator in each center.

This study follows a standard retention protocol procedure carried at both centers and has a long term posttreatment follow-up of 5 years. Patients will be recalled for follow-up appointments after 1, 3, 6, 12, 24, 36 and 60 months. At follow-up visits, we will perform the following: at 1, and 3 months - a clinical examination. At 6, 12, 24, 36, and 60 months - a clinical examination, a digital impression of the teeth known as "an intraoral scan" (Trios 3, 3Shape, Copenhagen, Denmark) and intraoral photographs. In addition, at 1, 6, and 12 months patients will be asked to fill out a Visual Analogue Scale (VAS) form regarding patient satisfaction Furthermore, we will investigate stability by superimposition (Orthoanalyzer, 3Shape, Copenhagen, Denmark) together with recording of adverse effects (i.e. any changes in torque and/or rotations of the teeth).

Study Type

Interventional

Enrollment (Anticipated)

126

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, 8000
        • Marie Anne Michele Cornelis
  • Norway
      • Oslo, Norway, 0455
        • University of Oslo

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 25 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Healthy patients.
  2. Age: 12-25 years old (at time of debonding).
  3. Presence of all maxillary and mandibular anterior teeth, with normal shape and size.
  4. Completion of a course of fixed appliance therapy involving both dental arches.
  5. Subjects willing to consent to the trial and comply with the trial regime.

No restriction to presenting initial malocclusion, type of active orthodontic treatment undertaken provided that it included full fixed appliances (functional/removable appliances in combination with fixed appliances - extraction or non-extraction)

Exclusion Criteria:

  1. Patients with cleft lip or palate, or both or any other craniofacial syndrome.
  2. Patients who had surgical correction of the jaws: Le fort I (2- or 3-piece maxilla) or SARPE (surgically assisted rapid palatal expansion).
  3. Lingual appliance treatments.
  4. Periodontal disease.
  5. Hypoplasia of enamel.
  6. Fluorosis.
  7. Active caries, restorations or fractures in the anterior teeth.
  8. Patients who have had separate debonding appointments for each jaw, with a difference of more than 2 months in between.
  9. Re-treated patients.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CAD/CAM
CAD/CAM custom-cut Nickel Titanium (NiTi) FR
Other: Bonding of either CAD/CAM or conventional multistranded stainless steel fixed retainer
Investigate and compare the clinical effectiveness of two types of fixed retainers; CAD/CAM vs. multistranded wire.
Active Comparator: Conventional multistranded
Conventional multistranded Stainless Steel (SS) FR
Other: Bonding of either CAD/CAM or conventional multistranded stainless steel fixed retainer
Investigate and compare the clinical effectiveness of two types of fixed retainers; CAD/CAM vs. multistranded wire.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Stability
Time Frame: From debonding (T1), and after 6, 12, 24, 36 and 60 months in retention phase (T4, T5, T6, T7, and T8 respectively)
Change in lower incisor crowding will be assessed using Little's Irregularity Index (LII). Change in overall occlusal stability will be assessed by the Peer Assessment Rating (PAR) index. In addition, changes in arch dimensions, occlusal relationships, and re-opening of extraction spaces will be recorded.
From debonding (T1), and after 6, 12, 24, 36 and 60 months in retention phase (T4, T5, T6, T7, and T8 respectively)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Failure rate and survival time
Time Frame: From the time of retainer bonding to the first failure episode: From debonding, and up to 60 months later
Calculated from the first day of retainer's bonding to the day of the first failure episode
From the time of retainer bonding to the first failure episode: From debonding, and up to 60 months later
Adverse effects
Time Frame: From debonding, and up to 60 months later
Screen for unexpected posttreatment changes in the mandibular anterior region associated with the use of both types of fixed retainers
From debonding, and up to 60 months later
Cost-effectiveness
Time Frame: From debonding, and up to 60 months later
Unit costs in euros (€) will be used to value the resources included
From debonding, and up to 60 months later
Patient satisfaction
Time Frame: From debonding, and after 1, 6 and 12 months in retention phase
Visual Analogue Scale (VAS)
From debonding, and after 1, 6 and 12 months in retention phase

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Collaborators

University of Oslo

Investigators

  • Principal Investigator: Marie A Cornelis, University of Aarhus

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 1, 2018

Primary Completion (Anticipated)

November 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

April 16, 2020

First Submitted That Met QC Criteria

May 11, 2020

First Posted (Actual)

May 15, 2020

Study Record Updates

Last Update Posted (Actual)

November 3, 2022

Last Update Submitted That Met QC Criteria

November 2, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 01286

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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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