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

Recruiting now · Not applicable

Conditions studied: Clear Aligner Orthodontic Treatment, Composite Attachment, Color Stability of Enamel

In brief

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.

Key facts

Study ID: NCT07234149
Run by: University of Sulaimani
People needed: 20
Starts: 2025-10-15
Expected to finish: 2026-12-16
Last updated by the study team: 2025-11-18

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

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.

You may not qualify if…

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.

Where it is running

Private Orthodontic Clinic - Kirkuk — Kirkuk, Kirkuk Governorate, Iraq (enrolling)
Private Orthodontic Clinic - Kirkuk — Kirkuk, Province, Iraq

Full record on ClinicalTrials.gov

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