Composite ResinsNCT07812220
Surface Wear of Clear 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
The aim of this study is to investigate the amount of surface wear that may occur during treatment with different composite materials used for clear aligner attachments. Two different flowable composites (AlignerFlow LC, VOCO GmbH, Cuxhaven, Germany; AlignerConnect, GC, Tokyo, Japan) will be used to bond the… 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
- 35 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 24 Dec 2024to 23 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, 34854
About this study
Official title: Evaluation of Surface Wear of Composites Used for Clear Aligner Attachments
The aim of this study is to investigate the amount of surface wear that may occur during treatment with different composite materials used for clear aligner attachments.
Two different flowable composites (AlignerFlow LC, VOCO GmbH, Cuxhaven, Germany; AlignerConnect, GC, Tokyo, Japan) will be used to bond the attachments in split mouth designs. To determine the composite for the upper right segment, a coin toss will be performed. The remaining quadrants will be bonded with alternate composite resin. After bonding, intraoral scans will be performed from baseline to 6 months for every 2 months. Stl files obtained from the scans will be imported to NemoStudio, to evaluate the volume loss of the attachments.
- Conditions
- Composite Resins, Clear Aligner Therapy
- Being tested
- GC Aligner Connect, VOCO AlignerFlow LC
- Keywords
- surface wear, volume loss, clear aligner attachments, flowable composite
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 volume wear
After importing stl files to NemoStudio software, T0 (without attachments), T1(immediately after bonding) and T4(6 months) scans will be superimposed using surface registration. Using Booleans extractions, T0 model will be removed from T1 and T4, leaving only the attachments. Software will calculate the volumes of attachments in mm³.
Measured: From baseline to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2026
- Study start24 Dec 2024
- Primary completion23 Jun 2026
- Study completion23 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 35 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, Study director, Marmara University Faculty of Dentistry Department of Orthodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07812220
- Sponsor's protocol ID
- 09.2024.503
- Status last verified
- Sep 2026
- First submitted
- 4 Sep 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Fausto da Veiga Jardim A, Curado de Freitas J, Estrela C. Surface wear and adhesive failure of resin attachments used in clear aligner orthodontic treatment. J Orofac Orthop. 2024 May;85(Suppl 1):52-62. doi: 10.1007/s00056-023-00471-5. Epub 2023 Jun 14.
PubMed 37314488Li Q, Yang K. Surface wear of attachments in patients during clear aligner therapy: a prospective clinical study. Prog Orthod. 2024 Feb 19;25(1):7. doi: 10.1186/s40510-023-00506-y.
PubMed 38369617
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Surface Wear of Composites Used for Clear Aligner Attachments
- ClinicalTrials.gov ID
- NCT07812220
- Acronym / sponsor ID
- 09.2024.503
- Conditions
- Composite Resins, Clear Aligner Therapy
- Keywords
- surface wear, volume loss, clear aligner attachments, flowable composite
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 24 Dec 2024 (actual)
- Primary completion
- 23 Jun 2026 (actual)
- Study completion
- 23 Jul 2026 (actual)
- First posted
- 10 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.
The aim of this study is to investigate the amount of surface wear that may occur during treatment with different composite materials used for clear aligner attachments.
Two different flowable composites (AlignerFlow LC, VOCO GmbH, Cuxhaven, Germany; AlignerConnect, GC, Tokyo, Japan) will be used to bond the attachments in split mouth designs. To determine the composite for the upper right segment, a coin toss will be performed. The remaining quadrants will be bonded with alternate composite resin. After bonding, intraoral scans will be performed from baseline to 6 months for every 2 months. Stl files obtained from the scans will be imported to NemoStudio, to evaluate the volume loss of the attachments.
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 volume wear
Time frame: From baseline to 6 months
After importing stl files to NemoStudio software, T0 (without attachments), T1(immediately after bonding) and T4(6 months) scans will be superimposed using surface registration. Using Booleans extractions, T0 model will be removed from T1 and T4, leaving only the attachments. Software will calculate the volumes of attachments in mm³.
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 10 Sep 2026.
- Background: PubMed 37314488Fausto da Veiga Jardim A, Curado de Freitas J, Estrela C. Surface wear and adhesive failure of resin attachments used in clear aligner orthodontic treatment. J Orofac Orthop. 2024 May;85(Suppl 1):52-62. doi: 10.1007/s00056-023-00471-5. Epub 2023 Jun 14.
- Background: PubMed 38369617Li Q, Yang K. Surface wear of attachments in patients during clear aligner therapy: a prospective clinical study. Prog Orthod. 2024 Feb 19;25(1):7. doi: 10.1186/s40510-023-00506-y.
- 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 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 10 Sep 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 volume wear (time frame: From baseline to 6 months). 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 NCT07812220, which also lists 2 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 10 Sep 2026.