Trials / Completed
CompletedNCT04847323
Clinical Effectiveness of Bonded Versus Vacuum-formed Retainers
Clinical Effectiveness of Bonded Versus Vacuum-formed Retainers After 12 Months: A Randomized Controlled Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- University of Sao Paulo · Academic / Other
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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. |
| 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. |
Timeline
- Start date
- 2021-02-01
- Primary completion
- 2022-04-01
- Completion
- 2022-04-01
- First posted
- 2021-04-19
- Last updated
- 2022-07-05
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT04847323. Inclusion in this directory is not an endorsement.