Clinical Effectiveness of Bonded Versus Vacuum-formed Retainers

NCT ID: NCT04847323

Last Updated: 2022-07-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-01

Study Completion Date

2022-04-01

Brief Summary

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The purpose of the study was to compare the clinical effectiveness of bonded versus vacuum-formed retainers regarding their retention capacity; periodontal health; survival rates; and patients' perception after 12 months of removal of fixed appliances.

The null hypotheses considered that there was no differences between the retainers in relation to the aspects evaluated.

Detailed Description

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This single-center randomized controlled trial was performed at the Department of Orthodontics, Bauru Dental School, University of São Paulo, Brazil.

A total of 50 patients completing orthodontic treatment were recruited. The patients were prospectively and randomly allocated into two groups. The first group consisted of 25 patients with canine-to-canine V-bend bonded retainers; while the second group comprised 25 patients with vacuum-formed retainers. In both groups, the same retainers were installed in the maxillary and mandibular arches.

Patients were evaluated at deboning (T0), after 3 months (T1), 6 months (T2), and 12 months (T3). In each appointment, digital models were obtained and the other clinical variables were evaluated. The primary and secondary outcomes were compared between retainers in the time-points evaluated.

Conditions

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Relapse

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

This was a 2-arm parallel randomized controlled trial. Therefore, the selected patients were randomly divided into two groups.

Group 1: Bonded V-bend retainers. Group 2: Vacuum-formed retainers. Randomization was performed through sequentially numbered, opaque envelopes prepared by a colleague independent of the study.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Masking of the principal investigator and participants was not be possible due to the nature of the interventions. Nonetheless, the outcome assessor was blinded for the periodontal and patient perception variables.

Study Groups

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V-bend Bonded Retainer

The V-bend retainer was bonded in the lingual surface of the anterior teeth. The retainer was constructed using 0.024" stainless steel wires. Differently from the conventional bonded retainers, this retainer presents V-bends in the sagittal direction, parallel to the occlusal plane in each interproximal contact point of the incisors and canines.

The retainers was bonded after adequate etching with phosphoric acid and application of adhesive with a low viscosity resin.

Group Type ACTIVE_COMPARATOR

V-bend Bonded Retainer

Intervention Type DEVICE

Traditional stainless steel retainer commonly bonded in the anterior teeth of the mandibular arch to maintain their alignment after orthodontic treatment.

Vacuum-formed Retainer

The removable Vacuum-formed retainers were made of acetate 1mm thickness. They were made at the same appointment of debonding using plaster models. The patients were instructed to use the retainers only during nights.

Group Type ACTIVE_COMPARATOR

Vacuum-formed Retainer

Intervention Type DEVICE

Removable retainers made of plastic and derivatives. Currently gaining popularity due to the increased use of esthetic aligners. These clear retainers have the objective to maintain stable the results obtained after orthodontic treatment. They cover all the surfaces of the teeth up to the first or second molars.

Interventions

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V-bend Bonded Retainer

Traditional stainless steel retainer commonly bonded in the anterior teeth of the mandibular arch to maintain their alignment after orthodontic treatment.

Intervention Type DEVICE

Vacuum-formed Retainer

Removable retainers made of plastic and derivatives. Currently gaining popularity due to the increased use of esthetic aligners. These clear retainers have the objective to maintain stable the results obtained after orthodontic treatment. They cover all the surfaces of the teeth up to the first or second molars.

Intervention Type DEVICE

Other Intervention Names

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Bonded Retainer Canine-to-Canine Retainer Fixed Retainer Thermoplastic Retainer Clear Retainer

Eligibility Criteria

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Inclusion Criteria

* Patients with the proper completion of orthodontic treatment and correction of the initial malocclusion.
* Acceptable oral hygiene (assessed through clinical examination).
* Presence of all teeth up to the second molars.
* Clinically acceptable teeth alignment.

Exclusion Criteria

* Patients with any systemic condition that may have an influence on periodontal health.
* Patients with facial deformities.
* Initial malocclusion that required extreme corrections, large transverse expansions or orthognathic surgery.
* History of periodontal diseases.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Sao Paulo

OTHER

Sponsor Role lead

Responsible Party

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Silvio Augusto Bellini-Pereira

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Bauru Dental School, University of São Paulo

Bauru, São Paulo, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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001

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

22092919.7.0000.5417

Identifier Type: -

Identifier Source: org_study_id

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