Angle's Class I MalocclusionNCT06504498
Effectiveness of Clear Aligners in Different Thicknesses
A study testing 0.5 mm-thick Duran® clear aligner and 0.75 mm-thick Duran® clear aligner in people with Angle's Class I Malocclusion and Crowding, Tooth, run by Mersin University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Angle's Class I Malocclusion, Crowding, Tooth
- What is being tested?
- 0.5 mm-thick Duran® clear aligner and 0.75 mm-thick Duran® clear aligner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 May 2021to 20 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Angle Class I malocclusion without skeletal discrepancy,
- Patients older than 18 years old with a full permanent dentition without supernumerary missing or impacted teeth except for 3rd molars,
- Non-extraction cases with mild crowding in maxillary arch (2-5 mm),
- Good oral health without periodontal disease or caries,
- No previous orthodontic treatment,
- Not taking pain medications.
Who cannot join
- History of previous orthodontic or interceptive treatment,
- Extraction cases with crowding of > 5 mm,
- Presence of anterior or posterior openbite or crossbite,
- Unwilling to be treated with clear aligners,
- Presence of supernumerary, missing or impacted teeth (other than third molars),
- Presence of any local/systemic problems or trauma, which may affect the pain level.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mersin University Faculty of Dentistry Department of Orthodontics
Mersin, 33110
About this study
Official title: 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).
Read the 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.
- Conditions
- Angle's Class I Malocclusion, Crowding, Tooth
- Being tested
- 0.5 mm-thick Duran® clear aligner, 0.75 mm-thick Duran® clear aligner
- Keywords
- Clear aligner thickness, Orthodontic tooth movement, Pain
- Medical subject headings
- Malocclusion, Angle Class I, Malocclusion, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.5 mm-thick Duran® clear alignerDevice
0.5 mm-thick clear aligner was used for orthodontic treatment.
0.75 mm-thick Duran® clear alignerDevice
0.75 mm-thick clear aligner was used for orthodontic treatment.
| Study group | Role | What they receive |
|---|---|---|
| 0.5 mm-thick Duran® clear aligners | Active comparator | 0.5 mm-thick clear aligners (Duran®; Scheu-Dental GmBH, Iserlohn, Germany). Receives: Device: 0.5 mm-thick Duran® clear aligner |
| 0.75 mm-thick Duran® clear aligners | Experimental | 0.75 mm-thick clear aligners (Duran®; Scheu-Dental GmBH, Iserlohn, Germany). Receives: Device: 0.75 mm-thick Duran® clear aligner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiographic tooth movement
Changes in the amount of maxillary cephalometric parameters using lateral cephalometric radiographs after 6 months.
Measured: At 6th months
Orthodontic tooth movement
Changes in intercanine, interpremolar, intermolar arch expansions and dental arch perimeter (maxillary dental parameters) using OrthoAnalyzer® software after 6 months.
Measured: At 6th months
Secondary outcomes (2)
Patients' pain level
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.
Measured: At the 4th hours, 2nd days, 1st week, 1st month, and 6th months
Patients' satisfaction level
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.
Measured: At the 4th hours, 2nd days, 1st week, 1st month, and 6th months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start10 May 2021
- Primary completion21 Jan 2022
- Study completion20 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Angle's Class I MalocclusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mersin University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saniye Merve CENGIZ, Mersin University
- Investigators
- Merve Göymen, Assoc Prof, Study director, Study Director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06504498
- Sponsor's protocol ID
- MEÜ-SCENGİZ-01
- Status last verified
- Jul 2024
- First submitted
- 28 Jun 2024
- Last updated
- 16 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sachdev S, Tantidhnazet S, Saengfai NN. Accuracy of Tooth Movement with In-House Clear Aligners. J World Fed Orthod. 2021 Dec;10(4):177-182. doi: 10.1016/j.ejwf.2021.08.003. Epub 2021 Oct 5.
PubMed 34625386Ho CT, Huang YT, Chao CW, Huang TH, Kao CT. Effects of different aligner materials and attachments on orthodontic behavior. J Dent Sci. 2021 Jul;16(3):1001-1009. doi: 10.1016/j.jds.2021.01.011. Epub 2021 Feb 12.
PubMed 34141116Cengiz SM, Goymen M. The effectiveness of orthodontic treatment with clear aligners in different thicknesses. Sci Rep. 2025 Feb 1;15(1):3958. doi: 10.1038/s41598-025-86345-9.
PubMed 39893227
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Orthodontic Treatment With Clear Aligners in Different Thicknesses
- ClinicalTrials.gov ID
- NCT06504498
- Acronym / sponsor ID
- MEÜ-SCENGİZ-01
- Conditions
- Angle's Class I Malocclusion, Crowding, Tooth
- Keywords
- Clear aligner thickness, Orthodontic tooth movement, Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Mersin UniversityUniversity, hospital or other
- Study start
- 10 May 2021 (actual)
- Primary completion
- 21 Jan 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.5 mm-thick Duran® clear aligners | Active comparator | Device: 0.5 mm-thick Duran® clear aligner0.5 mm-thick clear aligners (Duran®; Scheu-Dental GmBH, Iserlohn, Germany). |
| 0.75 mm-thick Duran® clear aligners | Experimental | Device: 0.75 mm-thick Duran® clear aligner0.75 mm-thick clear aligners (Duran®; Scheu-Dental GmBH, Iserlohn, Germany). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Angle Class I malocclusion without skeletal discrepancy,
- Patients older than 18 years old with a full permanent dentition without supernumerary missing or impacted teeth except for 3rd molars,
- Non-extraction cases with mild crowding in maxillary arch (2-5 mm),
- Good oral health without periodontal disease or caries,
- No previous orthodontic treatment,
Key exclusion criteria (6 listed)
- History of previous orthodontic or interceptive treatment,
- Extraction cases with crowding of > 5 mm,
- Presence of anterior or posterior openbite or crossbite,
- Unwilling to be treated with clear aligners,
- Presence of supernumerary, missing or impacted teeth (other than third molars),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 0.5 mm-thick Duran® clear aligner0.5 mm-thick clear aligner was used for orthodontic treatment. | Device | 0.5 mm-thick Duran® clear aligners |
| 0.75 mm-thick Duran® clear aligner0.75 mm-thick clear aligner was used for orthodontic treatment. | Device | 0.75 mm-thick Duran® clear aligners |
Primary outcome
Radiographic tooth movement
Time frame: At 6th months
Changes in the amount of maxillary cephalometric parameters using lateral cephalometric radiographs after 6 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.
2 secondary outcomes
Patients' pain level
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2024.
- Results publication: PubMed 34625386Sachdev S, Tantidhnazet S, Saengfai NN. Accuracy of Tooth Movement with In-House Clear Aligners. J World Fed Orthod. 2021 Dec;10(4):177-182. doi: 10.1016/j.ejwf.2021.08.003. Epub 2021 Oct 5.
- Results publication: PubMed 34141116Ho CT, Huang YT, Chao CW, Huang TH, Kao CT. Effects of different aligner materials and attachments on orthodontic behavior. J Dent Sci. 2021 Jul;16(3):1001-1009. doi: 10.1016/j.jds.2021.01.011. Epub 2021 Feb 12.
- Derived from this study: PubMed 39893227Cengiz SM, Goymen M. The effectiveness of orthodontic treatment with clear aligners in different thicknesses. Sci Rep. 2025 Feb 1;15(1):3958. doi: 10.1038/s41598-025-86345-9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Merve Göymen, Assoc Prof study director
Study Director
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 0.5 mm-thick Duran® clear aligner and 0.75 mm-thick Duran® clear aligner in people with Angle's Class I Malocclusion and Crowding, Tooth, run by Mersin University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Radiographic tooth movement (time frame: At 6th months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06504498, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jul 2024.