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Tooth Discoloration and Chairside Handling Time (Bonding-Debonding) in Flowable Versus Packable Composites for Clear Aligner Bonded Attachments: A Randomized Clinical Trial

RecruitingNAAges 18 Years - 40 YearsAllUniversity of Sulaimani
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In plain words

What the trial is, and whether it could suit you

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 (ฮ”E) 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 characteristic

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * 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 โ‰ค 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 Criteria: * 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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What it tests

  • flowable nanohybrid Composite Resin
  • Packable Microhybrid Composite Resin
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Where

2 sites
Private Orthodontic Clinic - Kirkuk
Kirkuk, Iraq
Private Orthodontic Clinic - Kirkuk
Kirkuk, Iraq
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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