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Efficacy of Orthodontic Tooth Movement Using Beveled and Conventional Attachments in Aligners: a Randomized Split-Mouth Clinical Trial
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.
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.
Age
18 - No limit years
Sex
ALL
Healthy Volunteers
Yes
Private orthodontic clinic
Curitiba, Paraná, Brazil
Start Date
October 25, 2024
Primary Completion Date
February 1, 2027
Completion Date
July 1, 2027
Last Updated
March 17, 2025
51
ESTIMATED participants
Arm 1: Beveled Attachments
DEVICE
Conventional Rectangular Attachments
DEVICE
Lead Sponsor
Neodent
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT06464003