flowable nanohybrid Composite Resin
DeviceA flowable nanocomposite (e.g., GC aligne connect) used to fabricate clear aligner attachments on enamel surfaces for comparison
Other names: packable microhybrid composite
NCT Number: NCT07234149
This randomized split-mouth clinical trial aims to compare two different composite materials used for bonding attachments in clear aligner orthodontic therapy. Twenty adult participants with Class I malocclusion and mild crowding will receive flowable nanocomposite attachments on one side of the dental arch and packable microhybrid composite attachments on the opposite side. The primary outcome is the color change (ΔE) of the enamel surface after attachment removal, measured by a spectrophotometer (VITA Easyshade). Secondary outcomes include bonding and debonding time and changes in enamel surface roughness before and after treatment. The study will be conducted at the Orthodontic Department, College of Dentistry, University of Sulaimani. The goal is to determine which composite material provides better color stability, easier handling, and minimal impact on enamel surface characteristics during clear aligner therapy.
Interested in participating?
Request Info18 year–40 year
All sexes
Interventional
Not applicable
Private Orthodontic Clinic - Kirkuk, Kirkuk, Kirkuk Governorate, Iraq
Clear aligner therapy has become a popular alternative to conventional fixed orthodontic appliances due to its superior esthetics and comfort. However, the efficiency of aligner treatment often depends on the proper use of composite attachments that enhance tooth movement and retention. Different composite resins are used for this purpose, but their optical stability and effect on enamel integrity after removal remain concerns.
This prospective, split-mouth randomized clinical trial compares a flowable nanocomposite and a packable microhybrid composite used for clear aligner attachments. Each participant will receive both materials in opposite quadrants to minimize inter-individual variability. Outcomes will include enamel color change (ΔE CIE Lab* values), bonding/debonding time, and surface roughness assessment using digital and optical analysis methods.
The study hypothesis is that the flowable nanocomposite will exhibit superior color stability and faster handling time, with comparable enamel surface effects to the packable composite. Results from this trial may help establish standardized protocols for attachment material selection in clinical orthodontic practice.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
A flowable nanocomposite (e.g., GC aligne connect) used to fabricate clear aligner attachments on enamel surfaces for comparison
Other names: packable microhybrid composite
Packable microhybrid composite resin used to fabricate clear aligner attachments.
Time frame: Baseline (before bonding) and after attachment removal
The color change (ΔE) of the enamel surface will be measured using a VITA Easyshade spectrophotometer based on CIE Lab* values before bonding and after debonding of the attachments. A ΔE value ≥ 3.3 will be considered clinically perceptible.
Contact information is provided by the study sponsor or research team.
. Hadi Mohammad M Ismail, PHD
CONTACT
Elaf Hussein Hasan H Hasan, BSD
CONTACT
University of Sulaimani
Other
Comparison of Color Stability, Bonding Time, and White Spot Lesion Between Flowable Nanocomposite and Packable Microhybrid Composite Used for Clear Aligner Attachments: A Split-Mouth Randomized Clinical Trial
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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.