Efficacy of Orthodontic Tooth Movement Using Beveled and Conventional Attachments in Aligners: a Randomized Split-Mouth Clinical Trial
Trial Snapshot
- Phase
- Not Applicable
- Status
- Enrolling By Invitation
- Sponsor
- Neodent
- Enrollment
- 51
- Locations
- 1
- Primary Endpoint
- To evaluate the efficacy of dental movement using beveled and conventional attachments
Study Overview
Brief Summary
The objective of this study is to evaluate the efficacy of tooth movement using beveled attachments and conventional attachments. The sample will be consecutively selected, comprising participants seeking orthodontic treatment in a private dental office within the recruitment period (from ethics committee approval to July 2027). Participants will be selected and randomized using a split-mouth study design. Groups will be divided into rectangular and beveled attachments, each further subdivided into subgroups for horizontal movements (Group H), vertical movements (Group V), and rotations (Group R), with 20 teeth/attachments per group, totaling a sample of 120 teeth/attachments. Digital study models will be obtained before the start of treatment and immediately after its completion. Additionally, clinical intraoral and extraoral photographs will be taken (pre- and post-treatment). Measurements will be collected from the initial and final digital models to determine the magnitude and direction of movements resulting from treatment. Descriptive statistics will be calculated for each type of dental movement evaluated. Paired tests will be conducted due to the split-mouth design. Correlation tests will be applied if necessary.
Detailed Description
Participant recruitment will take place after approval by the Research Ethics Committee until July 2027. The consultations will occur in a private clinic in Curitiba - PR, Brazil.
Participants will be selected and randomized according to the split-mouth study design. Teeth on each side will have different attachment configurations to aid orthodontic aligner movements. One side will use rectangular attachments, and the other side will use beveled attachments. Groups will be divided as follows:
Group H: 20 teeth/attachments with horizontal displacements (parallel to the occlusal plane) including tipping or mesio-distal translation - premolars and molars.
Group V: 20 teeth/attachments with vertical displacements (extrusion and intrusion) - incisors.
Group R: 20 teeth/attachments with mesio-distal rotations - canines and premolars.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Adults (18+ years) with permanent dentition
- •Candidates for aligner-based orthodontic treatment
- •Require bilateral tooth movements (e.g., extrusion, intrusion, rotation, tipping, mesiodistal translation)
- •Provide written informed consent
Exclusion Criteria
- •Contraindications to aligner use (e.g., manufacturer's guidelines)
- •Poor oral hygiene, active periodontal disease, or TMJ disorders
- •Allergies to aligner materials (e.g., polyurethane, PETG)
Arms & Interventions
Arm: Beveled attachments
The patients will receive beveled attachments on one side of the jaws
Intervention: Arm 1: Beveled Attachments (Device)
Rectangular Attachments
The patients will receive rectangular attachments on one side of the jaws
Intervention: Conventional Rectangular Attachments (Device)
Outcomes
Primary Outcomes
To evaluate the efficacy of dental movement using beveled and conventional attachments
Time Frame: From enrollment to the end of treatment, not exceeding 24 months.
Difference between the planned movement and the achieved movement, and the percentage of orthodontic dental movement achieved.
Secondary Outcomes
- To measure dental movements achieved with the treatment.(From enrollment to the end of treatment, not exceeding 24 months.)
- Measure the transverse dental changes achieved.(From enrollment to the end of treatment, not exceeding 24 months.)
- To assess participant satisfaction throughout the treatment.(From enrollment to the end of treatment, not exceeding 24 months.)