Effectiveness of Clear Aligners in Different Thicknesses

July 15, 2024 updated by: Saniye Merve CENGIZ, Mersin University

The Effectiveness of Orthodontic Treatment With Clear Aligners in Different Thicknesses

This study aimed to evaluate the effectiveness, pain, and satisfaction levels between patients treated with different thicknesses of clear aligners among Class I maxillary mild crowding cases. Two types of clear aligners with thicknesses of 0.5 and 0.75 mm were used. The null hypotheses were as follows: There is no clinical difference in effectiveness, pain, and satisfaction levels between different thickness of clear aligners. The alternate hypotheses were as follows: The thicker the clear aligner, the greater orthodontic force applied to tooth which affects the amount of orthodontic tooth movement, pain, and satisfaction levels of patients. The primary aim was to evaluate pre- and post-treatment changes in amount of orthodontic tooth movement. Maxillary cephalometric parameters were measured on lateral cephalograms and maxillary dental parameters were measured using OrthoAnalyzer, and compared before and after treatment. Visual Analogue Scale and Patient Satisfaction Evaluation Form were used in order to assess the pain and satisfaction levels of patients. Pain and satisfaction levels were measured before the aligner insertion (T0), at the 4th hour (T1), 2nd day (T2), 1st week (T3), 1st month (T4) and at the end of the treatment (T5).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

The sample size was computed to detect difference in the amount of orthodontic tooth movement between groups (G*Power, University of Dusseldorf, Germany). The calculated sample size was 14 for each group, similar to the previously published study (effect size = 0.8, α = 0.05, and 1 - β = 0.80). Lateral cephalograms were taken for all patients using the X-ray device (PM 2002 EC Proline; Planmeca OY, Helsinki, Finland) in the Department of Oral and Maxillofacial Radiology. Patients who satisfied the inclusion criteria were enrolled in this study and they were randomly separated into 2 groups (Group 1 and Group 2) based on the aligner thickness, each consisted of 14 patients. Patients in Group 1 were treated with 0.5 mm-thick clear aligners, patients in Group 2 were treated with 0.75 mm-thick clear aligners. The Little's Irregularity Index were calculated using OrthoAnalyzer software (3Shape, Copenhagen, Denmark) to standardize the amount of maxillary anterior crowding at the beginning of the treatment. Initial records were taken at the beginning of the treatment using an intraoral scanner (Trios 3®, 3Shape, Copenhagen, Denmark). Scanned data has been converted to standard tessellation language (STL) files and these files have been modified to create virtual setups for orthodontic tooth movement using OrthoAnalyzer software. Virtual setups were imported into a slicing software for model preparation before printing. A stereolithographic (SLA) 3D printer and liquid photopolymer were used to print resin models. These models were used as mould for thermoforming of the aligners using a vacuum-thermoforming machine (Model No: 202, Keystone Industries, Myerstown, USA). All aligners were manually cut with straight trim lines at gingival zenith to provide better comfort for the patients. Attachments were placed according to the software and interproximal reductions were performed by the same operator (SMC). Patients were followed at 2nd day (T2), 1st week (T3), 1st month (T4) and at the end of the treatment (T5). Pre- (T0) and post-treatment (T5) digital models, lateral cephalometric radiographs were compared. Pain and satisfaction levels of patients were assessed using Visual Analogue Scale and Patient Satisfaction Evaluation Form.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Mersin, Turkey, 33110
        • Mersin University Faculty of Dentistry Department of Orthodontics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Angle Class I malocclusion without skeletal discrepancy,
  2. Patients older than 18 years old with a full permanent dentition without supernumerary missing or impacted teeth except for 3rd molars,
  3. Non-extraction cases with mild crowding in maxillary arch (2-5 mm),
  4. Good oral health without periodontal disease or caries,
  5. No previous orthodontic treatment,
  6. Not taking pain medications.

Exclusion Criteria:

  1. History of previous orthodontic or interceptive treatment,
  2. Extraction cases with crowding of > 5 mm,
  3. Presence of anterior or posterior openbite or crossbite,
  4. Unwilling to be treated with clear aligners,
  5. Presence of supernumerary, missing or impacted teeth (other than third molars),
  6. Presence of any local/systemic problems or trauma, which may affect the pain level.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 0.5 mm-thick Duran® clear aligners
0.5 mm-thick clear aligners (Duran®; Scheu-Dental GmBH, Iserlohn, Germany).
Device: 0.5 mm-thick Duran® clear aligner
0.5 mm-thick clear aligner was used for orthodontic treatment.
Experimental: 0.75 mm-thick Duran® clear aligners
0.75 mm-thick clear aligners (Duran®; Scheu-Dental GmBH, Iserlohn, Germany).
Device: 0.75 mm-thick Duran® clear aligner
0.75 mm-thick clear aligner was used for orthodontic treatment.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Radiographic tooth movement
Time Frame: At 6th months
Changes in the amount of maxillary cephalometric parameters using lateral cephalometric radiographs after 6 months.
At 6th months
Orthodontic tooth movement
Time Frame: At 6th months
Changes in intercanine, interpremolar, intermolar arch expansions and dental arch perimeter (maxillary dental parameters) using OrthoAnalyzer® software after 6 months.
At 6th months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Patients' pain level
Time Frame: At the 4th hours, 2nd days, 1st week, 1st month, and 6th months
Changes in patients' pain level using a 10-cm VAS using ''no pain'' and ''severe pain'' as anchor descriptions at the 4th hours, 2nd days, 1st week, 1st month, and 6th months.
At the 4th hours, 2nd days, 1st week, 1st month, and 6th months
Patients' satisfaction level
Time Frame: At the 4th hours, 2nd days, 1st week, 1st month, and 6th months
Changes in patients' satisfaction level using ''Patient Satisfaction Evaluation Form 1'' at the 4th hours, 2nd days, 1st week, 1st month; and using ''Patient Satisfaction Evaluation Form 2'' at the 6th months.
At the 4th hours, 2nd days, 1st week, 1st month, and 6th months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mersin University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Merve Göymen, Assoc Prof, Study Director

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 10, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 21, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 20, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 28, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 16, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 15, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MEÜ-SCENGİZ-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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