Malocclusion
Conditions
Interventions
This is a single-arm, open-label interventional clinical trial with no randomization, in which 50 adult participants will receive combined orthodontic and restorative treatment
The treatment will consist of reverse planning with a diagnostic wax-up, followed by orthodontic movement with clear aligners limited to fourteen aligners, with an estimated maximum duration of up to
After alignment, minimally invasive tooth preparation and adhesive cementation of ceramic veneers in the upper anterior region will be performed, with clinical follow-up evaluations at a fixed frequen
For intraindividual comparison, a virtual digital simulation of an exclusively restorative approach will be performed for each patient using baseline condition models
Sponsors
Faculdade de Odontologia da Universidade de São Paulo
Faculdade de Odontologia da Universidade de São Paulo
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Age equal to or greater than 18 years; Seeking esthetic enhancement in the upper anterior region, from tooth 13 to tooth 23; Minor anterior orthodontic needs, such as mild rotations, crowding, or incisal misalignments, that can be managed with a limited orthodontic intervention, with a maximum of 14 aligners; Indication for laminate veneers based on esthetic needs not resolved by alignment alone, such as tooth shape, proportion, surface alterations, or minor wear; Good general health; Periodontally healthy, consistent with the AAP/EFP 2017 classification for periodontal health; Good oral hygiene, defined as full-mouth plaque score, FMPS, and full-mouth bleeding score, FMBS, both equal to or less than 25 percent; Ability and willingness to comply with all study procedures; Provision of signed informed consent
Exclusion criteria
Exclusion criteria: Complex orthodontic needs (for example, severe malocclusions or tooth movements extending beyond the anterior region) requiring comprehensive orthodontic therapy; No orthodontic indication (that is, patients with perfect alignment requiring only restorative treatment); Severe discoloration requiring extensive preparation to achieve masking; Esthetic concerns that could be fully resolved by orthodontic treatment alone (without the need for veneers); Cases in which omitting orthodontic treatment would result in excessive tooth reduction (for example, significantly rotated or displaced teeth); Use of medications or presence of systemic diseases contraindicating elective prosthetic procedures; Active malignancy or ongoing cancer treatment; History of substance abuse or suspected non-compliance; Inability to understand or follow study procedures due to language, cognitive, or psychological barriers
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluate the total volume of removed dental hard tissue, verified through the superimposition of digital models (STL files) and digital volumetric analysis, based on intraoral scans obtained immediately before and after tooth preparation | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate patient motivation, perception, and decision-making regarding the therapeutic options using a structured questionnaire applied before and after the standardized clinical orientation on the compared approaches;Evaluate the patient self-reported esthetic perception through the application of the Orofacial Esthetic Scale questionnaire at baseline pre-treatment, one week, one year, and three years after the cementation of the ceramic veneers;Evaluate the clinical quality of the ceramic veneer restorations based on the modified United States Public Health Service criteria at one and three years after cementation;Evaluate the success and survival rates of teeth and restorations as well as the incidence of failures and technical and biological complications through clinical and radiographic examinations at one and three years after cementation;Evaluate the costs related to the active and maintenance phases of treatment through the analysis of the total financial cost, number and duration of clinical visits, and laboratory costs from the initial diagnosis up to the three-year follow-up;Evaluate periodontal clinical parameters through manual probing and occlusal stability through the comparison of digital models at the initial stages, immediately after treatment, and at the one and three-year follow-ups | — |
Countries
BR
Contacts
Public ContactIsabella dos Reis
Faculdade de Odontologia da Universidade de São Paulo
Outcome results
None listed