Skip to main content
OpenTrials
Enrolling by Invitation

NCT Number: NCT06873932

Efficacy of Orthodontic Tooth Movement Using Beveled and Conventional Attachments in Aligners

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.

Enrolling by Invitation

Interested in participating?

Request Info

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Private orthodontic clinic

Curitiba, Paraná, 81270-200, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Arm 1: Beveled Attachments

Device

Beveled attachments applied to 20 teeth in each subgroup (horizontal, vertical, and rotational movements).

Conventional Rectangular Attachments

Device

Conventional rectangular attachments applied to 20 teeth in each subgroup (horizontal, vertical, and rotational movements).

Primary outcomes

  1. 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

  1. To measure dental movements achieved with the treatment.

    Time frame: From enrollment to the end of treatment, not exceeding 24 months.

    To measure the horizontal, vertical, and rotational dental movements achieved with the treatment

  2. Measure the transverse dental changes achieved.

    Time frame: From enrollment to the end of treatment, not exceeding 24 months.

    Transverse dental changes will be analyzed by comparing pre-treatment and post-treatment digital dental scans.

  3. To assess participant satisfaction throughout the treatment.

    Time frame: From enrollment to the end of treatment, not exceeding 24 months.

    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.

Sponsors and collaborators

Lead sponsor

Neodent

Industry

Registry information

Official study title

Efficacy of Orthodontic Tooth Movement Using Beveled and Conventional Attachments in Aligners: a Randomized Split-Mouth Clinical Trial

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Mar 13, 2025
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.