NCT07812220

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 24, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 23, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 23, 2026

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 4, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 10, 2026

Completed
Last Updated

September 10, 2026

Status Verified

September 1, 2026

Enrollment Period

1.5 years

First QC Date

September 4, 2026

Last Update Submit

September 4, 2026

Conditions

Composite ResinsClear Aligner Therapy

Keywords

surface wearvolume lossclear aligner attachmentsflowable composite

Outcome Measures

Primary Outcomes (1)

  • 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.

    From baseline to 6 months

Study Arms (2)

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.

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.

Procedure: VOCO AlignerFlow LC

Interventions

GC Aligner ConnectPROCEDURE

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

Upper Right Segment GC
VOCO AlignerFlow LCPROCEDURE

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

Upper Right Segment VOCO

Eligibility Criteria

Age14 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Marmara University Faculty of Dentistry Department of Orthodontics

Istanbul, 34854, Turkey (Türkiye)

Location

Related Publications (2)

  • 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.

    PMID: 37314488BACKGROUND

  • Li 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.

    PMID: 38369617BACKGROUND

Study Officials

  • Hanife Nuray Yılmaz

    Marmara University Faculty of Dentistry Department of Orthodontics

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
DDS

Study Record Dates

First Submitted

September 4, 2026

First Posted

September 10, 2026

Study Start

December 24, 2024

Primary Completion

June 23, 2026

Study Completion

July 23, 2026

Last Updated

September 10, 2026

Record last verified: 2026-09

Locations

TU(1)