Skip to main content
OpenTrials
Completed

NCT Number: NCT04847323

Clinical Effectiveness of Bonded Versus Vacuum-formed Retainers

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Relapse Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms Recurrence

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Bauru Dental School, University of São Paulo

Bauru, São Paulo, 17012-901, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Other names: Bonded Retainer, Canine-to-Canine Retainer, Fixed 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.

Other names: Thermoplastic Retainer, Clear Retainer

Primary outcomes

  1. 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).

    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.

Secondary outcomes

  1. Intercanine Distance

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

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

  2. Intermolar Distance

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

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

  3. Overjet

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

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

  4. Overbite

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

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

  5. Calculus Accumulation

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

    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.

  6. Gingival Health

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

    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.

  7. Plaque Accumulation

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

    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.

  8. Retainers Survival Rates

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

    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.

  9. Patients' Perception

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

    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.

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 19, 2021
Registry last updated
Jul 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.