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Completed

NCT Number: NCT07806214

Color Stability and Fluorescence Properties of Two Aligner Attachment Composites

This split mouth study aims to evaluate whether 2 different composite materials used for making clear aligner attachments change color over time and do they have different fluorescent characteristics when illuminated with ultraviolet light.

While bonding the attachments, a coin toss will determine which composite resin will be used for upper right segment. The remaining quadrants will be bonded with alternating composite resin. After bonding extraoral photographs under ultraviolet light with cheek retractors will be taken for fluorescence evaluation. Intraoral scans will be performed immediately after bonding and every two months up to six months for evaluating color change.

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Key information

Conditions

Composite Resins Clear Aligner Therapy

Age range

14 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara University Faculty of Dentistry Department of Orthodontics

Istanbul, 34854, Turkey (Türkiye)

About this study

In this study, attachments will be divided into two groups in a split-mouth design. To ensure randomization, dental arch will be divided into four quadrants, and the composite to be applied to the upper-right quadrant will be determined by a coin toss. The alternative composite will then be applied to the opposing quadrant. Two routinely available flowable composite materials in our department, manufactured specifically for clear aligner attachments, will be used (AlignerFlow LC, VOCO GmbH, Cuxhaven, Germany; AlignerConnect, GC, Tokyo, Japan). Following the application of the materials in accordance with the manufacturers' instructions, excess material will be removed under ultraviolet light using a carbide bur. Patients will be instructed to change their clear aligners every 10 days and wear them for at least 20 hours per day. Patients will be asked to remove the aligners only during meals, brush their teeth after eating, and reinsert them immediately. Oral hygiene instruction will be provided to all patients.After bonding, extraoral photographs will be captured under UV light and saved in JPEG format. These photographs will be transferred into the "Adobe Photoshop CC 2020" software. Brightness differences between the tooth surface and the attachment surface will be measured using the "Color Picker" tool within the software. Immediately after attachment placement and at two-month intervals throughout six months, digital scans will be obtained using an intraoral scanner (Trios 3, 3Shape Trios A/S, Copenhagen, Denmark). Using the shade-selection feature of the software, attachment shades will be recorded.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Receiving Invisalign treatment at the Clinic of the Department of Orthodontics, Faculty of Dentistry, Marmara University
  • Mild to moderate crowding
  • Exhibiting good oral hygiene
  • No active dental caries
  • Voluntarily agreeing to participate in the study and signing the written informed consent form
  • Having no history of any syndrome, systemic disease, or allergy

Exclusion criteria

  • Being pregnant or lactating
  • Presenting with advanced periodontal disease of a severity that could affect orthodontic treatment
  • Having prosthetic restorations within the oral cavity
  • Presenting with white spot lesions prior to orthodontic treatment

Treatment and study plan

GC Aligner Connect

Procedure

Patient's upper right segment will be bonded with GC Aligner Connect. Upper left VOCO, lower left GC, lower right VOCO.

VOCO AlignerFlow LC

Procedure

Patient's upper right segment will be bonded with VOCO AlignerFlow LC. Upper left GC, lower left VOCO, lower right GC.

Primary outcomes

  1. Within-patient difference between composites in ΔE₀₀(color difference)

    Time frame: From initial treatment to six months

    Shade codes acquired with scanner software was converted to CIE L*, a*, b* values using the table published by Budde et al(2024). Color change from beginning to 6 months was calculated using CIEDE2000 formula.

  2. Within-patient difference between materials in fluorescent contrast

    Time frame: Baseline

    Extraoral photographs under ultraviolet light were analysed in Adobe Photoshop 2020 (Adobe Systems Inc., San Jose, CA, USA). The L* coordinate was recorded using the colour sampler at the geometric centre of each attachment and at the centre of adjacent unbonded enamel on the same tooth. Fluorescent contrast was defined as ΔL* = L*attachment - L*enamel.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Official study title

Evaluation of Fluorescent Properties and Color Stability of 2 Different Composite Materials Used For Clear Aligner Attachments

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 8, 2026
Registry last updated
Sep 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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