RecruitingNot Applicable

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

Iraq20 participantsStarted 2025-10-15

Plain-language 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.

Who can participate

Age range

18 Years – 40 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Tooth Color (ΔE) After Attachment Removal

Timeframe: Baseline (before bonding) and after attachment removal

Trial details

NCT IDNCT07234149

SponsorUniversity of Sulaimani

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07-15

Contact for this trial

Elaf Hussein Hasan H Hasan, BSD

+9647715671612 elafhussein9494@gmail.com

View on ClinicalTrials.gov More Clear Aligner Orthodontic Treatment trials