Composite ResinsNCT07806214
Color Stability and Fluorescence Properties of Two Aligner Attachment Composites
A study testing GC Aligner Connect and VOCO AlignerFlow LC in people with Composite Resins and Clear Aligner Therapy, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Composite Resins, Clear Aligner Therapy
- What is being tested?
- GC Aligner Connect and VOCO AlignerFlow LC
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 21 Apr 2025to 6 Jul 2026
- 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University Faculty of Dentistry Department of Orthodontics
Istanbul, Istanbul, 34854
About this study
Official title: Evaluation of Fluorescent Properties and Color Stability of 2 Different Composite Materials Used For Clear Aligner Attachments
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.
Read the detailed description
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.
- Conditions
- Composite Resins, Clear Aligner Therapy
- Being tested
- GC Aligner Connect, VOCO AlignerFlow LC
- Keywords
- fluorescence, composite discoloration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GC Aligner ConnectProcedure or surgery
Patient's upper right segment will be bonded with GC Aligner Connect. Upper left VOCO, lower left GC, lower right VOCO.
VOCO AlignerFlow LCProcedure or surgery
Patient's upper right segment will be bonded with VOCO AlignerFlow LC. Upper left GC, lower left VOCO, lower right GC.
| Study group | Role | What they receive |
|---|---|---|
| Upper Right Segment GC | Experimental | Patient's upper right segment will be bonded with GC Aligner Connect. Upper left VOCO, lower left GC, lower right VOCO. Receives: Procedure: GC Aligner Connect |
| Upper Right Segment VOCO | Experimental | Patient's upper right segment will be bonded with VOCO AlignerFlow LC. Upper left GC, lower left VOCO, lower right GC. Receives: Procedure: VOCO AlignerFlow LC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Within-patient difference between composites in ΔE₀₀(color difference)
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.
Measured: From initial treatment to six months
Within-patient difference between materials in fluorescent contrast
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2026
- Study start21 Apr 2025
- Primary completion6 Jul 2026
- Study completion6 Jul 2026
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 Composite ResinsStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, İsmail Çevik, Marmara University
- Investigators
- Hanife Nuray Yılmaz, Associate Professor, Study director, Marmara University Faculty of Dentistry Department of Orthodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07806214
- Sponsor's protocol ID
- Nisan 2-2025-25
- Status last verified
- Oct 2026
- First submitted
- 2 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ercin O, Kurnaz M, Kopuz D. Evaluation of the color stability of attachments made with different resin composites. Am J Orthod Dentofacial Orthop. 2023 Oct;164(4):e121-e128. doi: 10.1016/j.ajodo.2023.07.008. Epub 2023 Aug 12.
PubMed 37565944Budde N, Arnold C, Wienke A, Schweyen R. Comparison of the Clinical Evaluation of Digital Tooth Shade Determination Using an Intraoral Scanner with Proven Subjective and Objective Methods. J Clin Med. 2024 Nov 6;13(22):6668. doi: 10.3390/jcm13226668.
PubMed 39597813Albertini P, Tauro R, Barbara L, Albertini E, Lombardo L. Fluorescence-aided removal of orthodontic composites: an in vivo comparative study. Prog Orthod. 2022 May 23;23(1):16. doi: 10.1186/s40510-022-00411-w.
PubMed 35599253
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Fluorescent Properties and Color Stability of 2 Different Composite Materials Used For Clear Aligner Attachments
- ClinicalTrials.gov ID
- NCT07806214
- Acronym / sponsor ID
- Nisan 2-2025-25
- Conditions
- Composite Resins, Clear Aligner Therapy
- Keywords
- fluorescence, composite discoloration
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 21 Apr 2025 (actual)
- Primary completion
- 6 Jul 2026 (actual)
- Study completion
- 6 Jul 2026 (actual)
- First posted
- 8 Sep 2026 (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 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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Upper Right Segment GC | Experimental | Procedure: GC Aligner ConnectPatient's upper right segment will be bonded with GC Aligner Connect. Upper left VOCO, lower left GC, lower right VOCO. |
| Upper Right Segment VOCO | Experimental | Procedure: VOCO AlignerFlow LCPatient's upper right segment will be bonded with VOCO AlignerFlow LC. Upper left GC, lower left VOCO, lower right GC. |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| GC Aligner ConnectPatient's upper right segment will be bonded with GC Aligner Connect. Upper left VOCO, lower left GC, lower right VOCO. | Procedure or surgery | Upper Right Segment GC |
| VOCO AlignerFlow LCPatient's upper right segment will be bonded with VOCO AlignerFlow LC. Upper left GC, lower left VOCO, lower right GC. | Procedure or surgery | Upper Right Segment VOCO |
Primary outcome
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.
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.
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 13 Oct 2026.
- Background: PubMed 37565944Ercin O, Kurnaz M, Kopuz D. Evaluation of the color stability of attachments made with different resin composites. Am J Orthod Dentofacial Orthop. 2023 Oct;164(4):e121-e128. doi: 10.1016/j.ajodo.2023.07.008. Epub 2023 Aug 12.
- Background: PubMed 39597813Budde N, Arnold C, Wienke A, Schweyen R. Comparison of the Clinical Evaluation of Digital Tooth Shade Determination Using an Intraoral Scanner with Proven Subjective and Objective Methods. J Clin Med. 2024 Nov 6;13(22):6668. doi: 10.3390/jcm13226668.
- Background: PubMed 35599253Albertini P, Tauro R, Barbara L, Albertini E, Lombardo L. Fluorescence-aided removal of orthodontic composites: an in vivo comparative study. Prog Orthod. 2022 May 23;23(1):16. doi: 10.1186/s40510-022-00411-w.
- Individual participant dataSharing planned: Undecided
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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.
Hanife Nuray Yılmaz, Associate Professor study director
Marmara University Faculty of Dentistry Department of Orthodontics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GC Aligner Connect and VOCO AlignerFlow LC in people with Composite Resins and Clear Aligner Therapy, run by Marmara 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 4 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 13 Oct 2026. 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?
Within-patient difference between composites in ΔE₀₀(color difference) (time frame: From initial treatment to six 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 NCT07806214, 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 13 Oct 2026.