Clinical trial NCT04847323: Clinical Effectiveness of Bonded Versus Vacuum-formed Retainers
Official title: Clinical Effectiveness of Bonded Versus Vacuum-formed Retainers After 12 Months: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Relapse
Keywords: Orthodontic Retainers
Orthodontic Appliances, Removable
Orthodontics
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2021-04-19
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in Little Irregularity Index (LII)
timeFrame: Changes were compared at T0 (Debonding); T1 (3 Months Follow-up); T2 (6 Months Follow-up); and T3 (12 Months Follow-up).
Secondary outcomes:
measure: Intercanine Distance
timeFrame: Evaluation was performed at T0 (Debonding); T1 (3 Months Follow-up); T2 (6 Months Follow-up); and T3 (12 Months Follow-up).
measure: Intermolar Distance
timeFrame: Evaluation was performed at T0 (Debonding); T1 (3 Months Follow-up); T2 (6 Months Follow-up); and T3 (12 Months Follow-up).
measure: Overjet
timeFrame: Evaluation was performed at T0 (Debonding); T1 (3 Months Follow-up); T2 (6 Months Follow-up); and T3 (12 Months Follow-up).
measure: Overbite
timeFrame: Evaluation was performed at T0 (Debonding); T1 (3 Months Follow-up); T2 (6 Months Follow-up); and T3 (12 Months Follow-up).
measure: Calculus Accumulation
timeFrame: Evaluation was performed at T0 (Debonding); T1 (3 Months Follow-up); T2 (6 Months Follow-up); and T3 (12 Months Follow-up).
measure: Gingival Health
timeFrame: Evaluation was performed at T0 (Debonding); T1 (3 Months Follow-up); T2 (6 Months Follow-up); and T3 (12 Months Follow-up).
measure: Plaque Accumulation
timeFrame: Evaluation was performed at T0 (Debonding); T1 (3 Months Follow-up); T2 (6 Months Follow-up); and T3 (12 Months Follow-up).
measure: Retainers Survival Rates
timeFrame: Evaluation was performed during the 12 Months of follow-up.
measure: Patients' Perception
timeFrame: Evaluation was performed at T0 (Debonding); T1 (3 Months Follow-up); T2 (6 Months Follow-up); and T3 (12 Months Follow-up).
Other outcomes:
Locations:
city: Bauru
country: Brazil
facility: Bauru Dental School, University of São Paulo
state: São Paulo
Study officials:
References: