Effectiveness of Clear Aligners in Different Thicknesses

NCT06504498 | Completed

• 1 other identifier: MEÜ-SCENGİZ-01
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief 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. 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).

Conditions

Angle's Class I Malocclusion; Crowding, Tooth

Keywords

Clear aligner thickness; Orthodontic tooth movement; Pain

Outcome Measures

Primary Outcomes (2)

• Radiographic tooth movement

  Changes in the amount of maxillary cephalometric parameters using lateral cephalometric radiographs after 6 months.

  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.

  At 6th months

Secondary Outcomes (2)

• Patients' pain level

  At the 4th hours, 2nd days, 1st week, 1st month, and 6th months

• Patients' satisfaction level

  At the 4th hours, 2nd days, 1st week, 1st month, and 6th months

Study Arms (2)

0.5 mm-thick Duran® clear aligners

ACTIVE COMPARATOR

0.5 mm-thick clear aligners (Duran®; Scheu-Dental GmBH, Iserlohn, Germany).

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).

Device: 0.75 mm-thick Duran® clear aligner

Interventions

0.5 mm-thick Duran® clear aligner DEVICE

0.5 mm-thick clear aligner was used for orthodontic treatment.

0.5 mm-thick Duran® clear aligners

0.75 mm-thick Duran® clear aligner DEVICE

0.75 mm-thick clear aligner was used for orthodontic treatment.

0.75 mm-thick Duran® clear aligners

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mersin University: lead

Study Sites (1)

Mersin University Faculty of Dentistry Department of Orthodontics

Mersin, 33110, Turkey (Türkiye)

Location

Related Publications (3)

• 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.

  PMID: 34625386 RESULT

• Ho 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.

  PMID: 34141116 RESULT

• Cengiz 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.

  PMID: 39893227 DERIVED

MeSH Terms

Conditions

Malocclusion, Angle Class I; Malocclusion; Pain

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Merve Göymen, Assoc Prof

  Study Director

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 28, 2024
• First Posted: July 16, 2024
• Study Start: May 10, 2021
• Primary Completion: January 21, 2022
• Study Completion: May 20, 2022
• Last Updated: July 16, 2024

Record last verified: 2024-07

Locations

TU (1)