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RelapseNCT04847323

Clinical Effectiveness of Bonded Versus Vacuum-formed Retainers

A study testing V-bend Bonded Retainer and Vacuum-formed Retainer in people with Relapse, run by University of Sao Paulo at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 12 years and olderHealthy volunteers can take part
Conditions the study is for
Relapse
What is being tested?
V-bend Bonded Retainer and Vacuum-formed Retainer
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteBrazil
Study dates
1 Feb 2021to 1 Apr 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 12 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Bauru Dental School, University of São Paulo

    Bauru, São Paulo, 17012-901

Other trials in Brazil

About this study

Official title: Clinical Effectiveness of Bonded Versus Vacuum-formed Retainers After 12 Months: A Randomized Controlled Trial

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.

Read the detailed description

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
Relapse
Being tested
V-bend Bonded Retainer, Vacuum-formed Retainer
Keywords
Orthodontic Retainers, Orthodontic Appliances, Removable, Orthodontics
Medical subject headings
Recurrence

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • V-bend Bonded RetainerDevice

    Also called Bonded Retainer, Canine-to-Canine Retainer, Fixed Retainer

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

  • Vacuum-formed RetainerDevice

    Also called Thermoplastic Retainer, Clear 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.

Study groups in NCT04847323
Study groupRoleWhat they receive
V-bend Bonded RetainerActive comparatorThe 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.
Receives: Device: V-bend Bonded Retainer
Vacuum-formed RetainerActive comparatorThe 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.
Receives: Device: Vacuum-formed Retainer

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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)

  1. Intercanine Distance

    Distance between the cusp tips of the right and left permanent canines. In the maxilla and mandible.

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

  2. Intermolar Distance

    Distance between the tips of the mesiobuccal cusps of the first right and left permanent molars. In the maxilla and mandible.

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

  3. Overjet

    Distance between the incisal edge of the maxillary central incisor and the incisal edge of the mandibular incisor, parallel to the occlusal plane.

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

  4. Overbite

    Distance between the incisal edge of the upper central incisor and the incisal edge of the lower incisor, perpendicular to the occlusal plane.

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

  5. Calculus Accumulation

    Periodontal status was evaluated regarding the amount of calculus accumulation using the Simplified Oral Hygiene Index from Greene and Vermillion, 1978. The extension of calculus was estimated visually in all erupted teeth. Each teeth received a score ranging from 0 to 3. Minor scores indicated absence of calculus while higher scores indicated greater calculus accumulation on the tooth surfaces.

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

  6. Gingival Health

    Periodontal status was evaluated regarding the patients' gingival health using the Gingival Index described by Loe, 1967. The gingival health was estimated clinically with a periodontal probe in all erupted teeth. Each teeth received a score ranging from 0 to 3. Minor scores indicated acceptable gingival health while higher scores indicated greater inflammation and unacceptable gingival health.

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

  7. Plaque Accumulation

    Periodontal status was evaluated regarding the amount of plaque accumulation using the Plaque Index from Loe, 1967. The extension of plaque was estimated clinically using a periodontal probe in all erupted teeth. Each teeth received a score ranging from 0 to 3. Minor scores indicated absence of plaque while higher scores indicated greater plaque accumulation on the tooth surfaces.

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

  8. Retainers Survival Rates

    The number and cause of failures for each patient was recorded during the 12-month follow-up. From these data, the total survival rate of the retainers was estimated as a percentage, as well as its major causes of failure.

    Measured: Evaluation was performed during the 12 Months of follow-up.

  9. Patients' Perception

    Patients' perception was assessed using a Visual Analogue Scale (VAS) containing a questionnaire with 9 questions related to the use of the retainers. Each question received a score ranging from 0 to 10. Minor scores indicated that the patient felt extremely uncomfortable during the retention period while higher scores indicated that the patients felt highly comfortable.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2021
  2. Study start1 Feb 2021
  3. Primary completion1 Apr 2022
  4. Study completion1 Apr 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04847323
Sponsor's protocol ID
22092919.7.0000.5417
Other IDs
001
Status last verified
Jun 2022
First submitted
8 Apr 2021
Last updated
5 Jul 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing V-bend Bonded Retainer and Vacuum-formed Retainer in people with Relapse, run by University of Sao Paulo at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in Little Irregularity Index (LII) (time frame: Changes were compared at T0 (Debonding); T1 (3 Months Follow-up); T2 (6 Months Follow-up); and T3 (12 Months Follow-up).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04847323.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2022.

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