An interventional study of flowable nanohybrid Composite Resin and Packable Microhybrid Composite Resin in Clear Aligner Orthodontic Treatment, Composite Attachment and Color Stability of Enamel, sponsored by University of Sulaimani. Recruiting at 2 sites in Iraq. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-11-18.
Sponsored by University of Sulaimani · Not applicable, Interventional, and Treatment
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.
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.
University of Sulaimani is the lead sponsor of 16 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will receive packable microcomposite attachments (e.g., GC G-ænial Universal ) on one side of the dental arc attachments on one quadrant of the dental arch for clear aligner therapy. Color change, bonding/debonding time, and enamel roughness will be assessed
Device: Packable Microhybrid Composite Resin
Participants will receive flowable nanocomposite (e.g., GC aligner connect ) attachments on the opposite quadrant of the same dental arch.Color change, bonding/debonding time, and enamel roughness will be assessed.
Device: flowable nanohybrid Composite Resin
A flowable nanocomposite (e.g., GC aligne connect) used to fabricate clear aligner attachments on enamel surfaces for comparison
Also known as: packable microhybrid composite
Packable microhybrid composite resin used to fabricate clear aligner attachments.
Change in Tooth Color (ΔE) 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.
Time frame: Baseline (before bonding) and after attachment removal
Plan to share: No — ot applicable. Individual participant data will not be shared. Only summarized results will be published.
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University of Sulaimani