Clinical trial NCT06873932: Efficacy of Orthodontic Tooth Movement Using Beveled and Conventional Attachments in Aligners
Official title: Efficacy of Orthodontic Tooth Movement Using Beveled and Conventional Attachments in Aligners: a Randomized Split-Mouth Clinical Trial
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Malocclusion
Tooth Movement Techniques
Lead sponsor: Neodent
Sponsor class: INDUSTRY
First posted: 2025-03-13
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.

Digital study models (intraoral scanner) will be obtained before and after treatment. These intraoral scans will be analyzed alongside the planned movement models generated by the orthodontic treatment planning software.

Treatment efficacy will be analyzed using tooth-tracking methodology in Geomagic Control X, measuring the differences between planned and achieved movements and calculating the percentage of achieved orthodontic tooth movement.

Additionally, pre- and post-treatment clinical photographs will be taken:

Intraoral:

Frontal in occlusion; Right and left lateral views in occlusion; Occlusal views of upper and lower arches.

Extraoral:

Frontal with lips at rest; Frontal with a wide smile; Profile with lips at rest. All participants will receive orthodontic aligner treatment supervised by a qualified professional capable of providing relevant care under clinical trial conditions. Diagnosis, movement planning, and therapy monitoring procedures (e.g., aligner replacement frequency) for each individual will be established by the researcher, respecting the manufacturer's specified instructions.

The sample size was 30 participants will be recruited, totaling a sample of 120 teeth/attachments.

Participant satisfaction will be recorded pre-treatment, during follow-up, and post-treatment. In this study, oral health-related quality of life will be assessed through the OHIP-14 (Oral Health Impact Profile-14) questionnaire as a measure of participant satisfaction with the treatment.

Initial and final digital models will be imported using software, where measurements will be taken to identify the magnitude and direction of movements resulting from treatment with different attachment types:

Horizontal displacements (parallel to the occlusal plane) including tipping or mesio-distal translation - premolars and molars.

Vertical displacements (extrusion and intrusion) - incisors. Mesio-distal rotations - canines and premolars.

Descriptive statistics will be calculated for each type of tooth movement evaluated and described by mean, standard deviation, median, quartiles, minimum, and maximum. Paired tests will be conducted due to the split-mouth design. Correlation tests will also be applied if necessary.

Eligibility criteria: 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)

Primary outcomes:
measure: To evaluate the efficacy of dental movement using beveled and conventional attachments
timeFrame: From enrollment to the end of treatment, not exceeding 24 months.
Secondary outcomes:
measure: To measure dental movements achieved with the treatment.
timeFrame: From enrollment to the end of treatment, not exceeding 24 months.
measure: Measure the transverse dental changes achieved.
timeFrame: From enrollment to the end of treatment, not exceeding 24 months.
measure: To assess participant satisfaction throughout the treatment.
timeFrame: From enrollment to the end of treatment, not exceeding 24 months.
Other outcomes:
Locations:
city: Curitiba
country: Brazil
facility: Private orthodontic clinic
state: Paraná
Study officials:
References: