ClinicalTrials.gg
Enrolling by invitationNCT06873932Updated Mar 17, 2025

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

An interventional study of Arm 1: Beveled Attachments and Conventional Rectangular Attachments in Malocclusion and Tooth Movement Techniques, sponsored by Neodent. Enrolling by invitation at 1 site in Brazil. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-03-17.

Sponsored by Neodent (part of Institut Straumann AG) · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Oct 2024, registered Mar 2025).

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Phase
Not applicable
Study type
Interventional
Enrollment
51
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 16 studies in Malocclusion with a site in Brazil — 1 open to participants now, 3 under way, none of them phase 3. Malocclusion · Brazil.

Planned enrollment
3rd of 14
51 · median 36
Started
2024
with 1 other
No phase
12 of 16
1 open now
Registered
15th of 16
by date
Lead sponsor
2 of 16
Neodent

Among the 16 studies in Malocclusion with a site in Brazil, this one is the 3rd largest by planned enrollment of the 14 interventional ones that give a count, is one of 2 that started in 2024, is one of 12 with no phase, and was the 15th registered.

Malocclusion

323 studies on the registry are indexed under Malocclusion; 84 are open to participants now.

Browse Malocclusion studies →

Open to participants now

1 of the 16 studies in Malocclusion with a site in Brazil is open now.

A study can be open while its sites in Brazil have not opened yet or have stopped. Only those recruiting at a site in Brazil →

Who these studies take

Of the 41 Malocclusion studies recruiting now, 8 (20%) set no upper age limit and 33 (80%) stop at 75 or younger; 32 take children under 18; 18 take healthy volunteers.

This study: 18 Years and older · all sexes · healthy volunteers too.

The full table on the hub →

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02

Study 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.

Read the 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.

03

Conditions studied

  • Malocclusion
  • Tooth Movement Techniques

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04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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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

Exclusion criteria

Exclusion Criteria:

  • 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)
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Single (Participant)
Enrollment
51 participants (estimated)

Study arms

  • Experimental
    Arm: Beveled attachments

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

    Device: Arm 1: Beveled Attachments

  • Active comparator
    Rectangular Attachments

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

    Device: Conventional Rectangular Attachments

Interventions

  • DeviceArm 1: Beveled Attachments

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

  • DeviceConventional Rectangular Attachments

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

06

What researchers measure

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.

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

Secondary outcomes

  1. To measure dental movements achieved with the treatment.

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

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

  2. Measure the transverse dental changes achieved.

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

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

  3. To assess participant satisfaction throughout the treatment.

    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.

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

07

Study locations

1 site
  • Private orthodontic clinic
    Curitiba, Paraná 81270-200, Brazil
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Oct 2024 (actual). Primary completion is estimated for Feb 2027, 28 months after the start.

Of 163 interventional studies with no phase under Malocclusion, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 32. This study's planned 28 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 7, 2025
First posted
Mar 13, 2025
StartActual
Oct 25, 2024
Primary completionEst.
Feb 2027
CompletionEst.
Jul 2027
Last update
Mar 17, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 17, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06873932
Lead sponsor
Neodent
Responsible party
Sponsor
First posted
Mar 13, 2025
Start date
Oct 25, 2024
Primary completion
Feb 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
Mar 17, 2025

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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