Comparing tooth discoloration and chairside bonding time for flowable versus packable composites used with clear aligner attachments
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
This test will see if a flowable nanocomposite or a packable microhybrid composite causes less tooth discoloration and is faster to place for adults undergoing clear aligner treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 40 Years |
| Sex | All |
| Sponsor | University of Sulaimani Academic / other |
| Locations | 2 sites (Kirkuk, Kirkuk Governorate and 1 other locations) |
| Trial ID | NCT07234149 on ClinicalTrials.gov |
What this trial studies
This is a prospective split‑mouth randomized trial in which 20 adult patients will receive flowable nanocomposite attachments on one side of the arch and packable microhybrid attachments on the opposite side to minimize individual variation. The primary outcome is enamel color change (CIE L*a*b* ΔE) after attachment removal measured with a spectrophotometer, and secondary outcomes include bonding and debonding chairside time plus enamel surface roughness before and after treatment. Bonding and debonding procedures will be timed and digital/optical methods used for surface analysis. The work will be performed at the Orthodontic Department, College of Dentistry, University of Sulaimani with procedures carried out in affiliated private orthodontic clinics in Kirkuk.
Who should consider this trial
Good fit: Adults aged 18–40 with Class I malocclusion and mild crowding who have intact buccal enamel, good oral hygiene, and are scheduled for attachment debonding after clear aligner treatment are ideal candidates.
Not a fit: Patients with enamel defects, restorations or cracks on assessed surfaces, recent bleaching, severe crowding or spacing, or those unable to attend clinic visits are unlikely to benefit from the findings.
Why it matters
Potential benefit: If successful, the results could identify a composite that reduces attachment‑related staining and shortens chairside handling during clear aligner therapy.
How similar studies have performed: Laboratory and a few limited clinical reports have compared composite types for attachments with mixed results, but randomized split‑mouth clinical data directly comparing these specific materials are sparse.
Eligibility criteria
Show full inclusion / exclusion criteria
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 ≤ 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.
Where this trial is running
Kirkuk, Kirkuk Governorate and 1 other locations
- Private Orthodontic Clinic - Kirkuk — Kirkuk, Kirkuk Governorate, Iraq (Recruiting)
- Private Orthodontic Clinic - Kirkuk — Kirkuk, Province, Iraq (Not_yet_recruiting)
Study contacts
- Principal investigator: Ali I Ibrahim — College of Dentistry, University of Sulaimani.
- Study coordinator: Elaf Hussein Hasan H Hasan, BSD
- Email: elafhussein9494@gmail.com
- Phone: +9647715671612
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.