Clinical Effectiveness of Bonded Versus Vacuum-formed Retainers

NCT04847323 | Completed

• 2 other identifiers: 22092919.7.0000.5417001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Relapse

Keywords

Orthodontic Retainers; Orthodontic Appliances, Removable; Orthodontics

Outcome Measures

Primary Outcomes (1)

• Changes in Little Irregularity Index (LII)

  Stability was evaluated comparing the changes in the Little Irregularity Index (LII) between time-points. The average of the linear distances between the anatomical contact points of the anterior teeth were considered.

  Changes were compared at T0 (Debonding); T1 (3 Months Follow-up); T2 (6 Months Follow-up); and T3 (12 Months Follow-up).

Secondary Outcomes (9)

• Intercanine Distance

  Evaluation was performed at T0 (Debonding); T1 (3 Months Follow-up); T2 (6 Months Follow-up); and T3 (12 Months Follow-up).

• Intermolar Distance

  Evaluation was performed at T0 (Debonding); T1 (3 Months Follow-up); T2 (6 Months Follow-up); and T3 (12 Months Follow-up).

• Overjet

  Evaluation was performed at T0 (Debonding); T1 (3 Months Follow-up); T2 (6 Months Follow-up); and T3 (12 Months Follow-up).

• Overbite

  Evaluation was performed at T0 (Debonding); T1 (3 Months Follow-up); T2 (6 Months Follow-up); and T3 (12 Months Follow-up).

• Calculus Accumulation

  Evaluation was performed at T0 (Debonding); T1 (3 Months Follow-up); T2 (6 Months Follow-up); and T3 (12 Months Follow-up).

Study Arms (2)

V-bend Bonded Retainer

ACTIVE COMPARATOR

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.

Device: V-bend Bonded Retainer

Vacuum-formed Retainer

ACTIVE COMPARATOR

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.

Device: Vacuum-formed Retainer

Interventions

V-bend Bonded Retainer DEVICE

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

Also known as: Bonded Retainer, Canine-to-Canine Retainer, Fixed Retainer

V-bend Bonded Retainer

Vacuum-formed Retainer 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.

Also known as: Thermoplastic Retainer, Clear Retainer

Vacuum-formed Retainer

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

Bauru Dental School, University of São Paulo

Bauru, São Paulo, 17012-901, Brazil

Location

MeSH Terms

Conditions

Recurrence

Interventions

Orthodontic Appliances, Fixed

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Orthodontic Appliances; Orthodontics; Dentistry

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: April 8, 2021
• First Posted: April 19, 2021
• Study Start: February 1, 2021
• Primary Completion: April 1, 2022
• Study Completion: April 1, 2022
• Last Updated: July 5, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)