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

NCT04389879 | Unknown DMC

• 1 other identifier: 01286
• Study Type: interventional
• Target: 126
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Relapse

Keywords

Orthodontic retainer; relapse; stability; CAD/CAM; fixed retainer

Outcome Measures

Primary Outcomes (1)

• Stability

  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 Outcomes (4)

• Failure rate and survival time

  From the time of retainer bonding to the first failure episode: From debonding, and up to 60 months later

• Adverse effects

  From debonding, and up to 60 months later

• Cost-effectiveness

  From debonding, and up to 60 months later

• Patient satisfaction

  From debonding, and after 1, 6 and 12 months in retention phase

Study Arms (2)

CAD/CAM

EXPERIMENTAL

CAD/CAM custom-cut Nickel Titanium (NiTi) FR

Other: Bonding of either CAD/CAM or conventional multistranded stainless steel fixed retainer

Conventional multistranded

ACTIVE COMPARATOR

Conventional multistranded Stainless Steel (SS) FR

Other: Bonding of either CAD/CAM or conventional multistranded stainless steel fixed retainer

Interventions

Bonding of either CAD/CAM or conventional multistranded stainless steel fixed retainer OTHER

Investigate and compare the clinical effectiveness of two types of fixed retainers; CAD/CAM vs. multistranded wire.

CAD/CAM; Conventional multistranded

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy patients.
• Age: 12-25 years old (at time of debonding).
• Presence of all maxillary and mandibular anterior teeth, with normal shape and size.
• Completion of a course of fixed appliance therapy involving both dental arches.
• 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)

You may not qualify if:

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

Sponsors & Collaborators

• University of Aarhus: lead
• University of Oslo: collaborator

Study Sites (2)

Marie Anne Michele Cornelis

Aarhus, 8000, Denmark

Location

University of Oslo

Oslo, 0455, Norway

Location

Related Publications (26)

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MeSH Terms

Conditions

Recurrence

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Marie A Cornelis

  University of Aarhus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The outcome assessor will be blinded only to the patient satisfaction and cost-effectiveness outcomes.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Two-center randomized controlled clinical trial. Consecutive patients who are about to finish their fixed appliance orthodontic treatment at the two orthodontic departments will be screened for eligibility criteria. Eligible subjects will be randomized to have one of either two different fixed retainers to be bonded (to the upper and lower anterior teeth) by one operator in each center. Subjects will be allocated 1:1 into one of the two groups.

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: May 15, 2020
• Study Start: September 1, 2018
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: November 3, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1); NO (1)