Tooth Discoloration and Chairside Handling Time (Bonding-Debonding) in Flowable Versus Packable Composites for Clear Aligner Bonded Attachments: A Randomized Clinical Trial
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
University of Sulaimani
20 participants
Oct 15, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria10
- Adults 18-40 years.
- patients with class l malocclusion with in which there treatment will be completed in 6 month .
- Completed clear aligner therapy and scheduled for attachment debonding at the study clinic.
- Permanent teeth with intact buccal enamel at assessment sites.
- No caries, restorations, cracks, fluorosis, or hypoplasia on assessed surfaces.
- No bleaching within 6 months prior to baseline.
- Good general health (ASA I-II) and able to provide written informed consent.
- Satisfactory oral hygiene and gingival health (e.g., GI ≤ 1).
- Willing and able to complete measurements: spectrophotometric shade (CIE L\*, a\*, b\*), photographs/scans, and VAS for pain/discomfort.
- Available for all visits and follow-up assessment.
Exclusion Criteria10
- Patients younger than 18 or older than 40 years.
- Patients presenting with severe or very severe anterior crowding (LII \> 6 mm) or spacing will exclude from the study. Cases with posterior crossbites, open bites, or skeletal discrepancies
- Presence of systemic diseases (ASA \> II) that may affect healing, pain perception, or enamel quality.
- Teeth with caries, restorations, fractures, enamel cracks, fluorosis, hypoplasia, or discolorations on the buccal surfaces at assessment sites.
- Patients who have undergone tooth bleaching within the last 6 months.
- History of major dental surgery or trauma in the study region.
- Patients with poor oral hygiene or gingival inflammation (GI \> 1).
- Pregnant or lactating women.
- Patients with allergy or hypersensitivity to composite resins or dental adhesives.
- Individuals unable to provide informed consent or not willing to comply with study visits.
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Interventions
A flowable nanocomposite (e.g., GC aligne connect) used to fabricate clear aligner attachments on enamel surfaces for comparison
Packable microhybrid composite resin used to fabricate clear aligner attachments.
Locations(2)
View Full Details on ClinicalTrials.gov
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NCT07234149