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

NCT06873932 | Enrolling By Invitation

• 1 other identifier: CC.2024.Attachments
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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.

Conditions

Malocclusion; Tooth Movement Techniques

Outcome Measures

Primary Outcomes (1)

• To evaluate the efficacy of dental movement using beveled and conventional attachments

  Difference between the planned movement and the achieved movement, and the percentage of orthodontic dental movement achieved.

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

Secondary Outcomes (3)

• 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.

Study Arms (2)

Arm: Beveled attachments

EXPERIMENTAL

The patients will receive beveled attachments on one side of the jaws

Device: Arm 1: Beveled Attachments

Rectangular Attachments

ACTIVE COMPARATOR

The patients will receive rectangular attachments on one side of the jaws

Device: Conventional Rectangular Attachments

Interventions

Arm 1: Beveled Attachments DEVICE

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

Arm: Beveled attachments

Conventional Rectangular Attachments DEVICE

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

Rectangular Attachments

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Neodent: lead

Study Sites (1)

Private orthodontic clinic

Curitiba, Paraná, 81270-200, Brazil

Location

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2025
• First Posted: March 13, 2025
• Study Start: October 25, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: March 17, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)