Actively Recruiting
Tooth Discoloration and Chairside Handling Time (Bonding-Debonding) in Flowable Versus Packable Composites for Clear Aligner Bonded Attachments: A Randomized Clinical Trial
Led by University of Sulaimani · Updated on 2025-11-18
20
Participants Needed
2
Research Sites
61 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Tooth Discoloration and Chairside Handling Time (Bonding-Debonding) in Flowable Versus Packable Composites for Clear Aligner Bonded Attachments: A Randomized Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 40 years
- Patients with Class I malocclusion expected to complete treatment within 6 months
- Completed clear aligner therapy and scheduled for attachment removal at the study clinic
- Permanent teeth with intact buccal enamel at assessment sites
- No caries, restorations, cracks, fluorosis, or hypoplasia on assessed surfaces
- No tooth bleaching within 6 months before baseline
- Good general health (ASA I-II) and able to give written informed consent
- Satisfactory oral hygiene and gingival health (Gingival Index 1)
- Willing and able to complete spectrophotometric measurements, photographs, scans, and pain/discomfort assessments
- Available for all visits and follow-up assessments
You will not qualify if you...
- Younger than 18 or older than 40 years
- Severe or very severe anterior crowding (LII > 6 mm) or spacing
- Presence of posterior crossbites, open bites, or skeletal discrepancies
- Systemic diseases (ASA > II) affecting healing, pain perception, or enamel quality
- Teeth with caries, restorations, fractures, enamel cracks, fluorosis, hypoplasia, or discolorations on buccal surfaces
- Tooth bleaching within the last 6 months
- History of major dental surgery or trauma in the study area
- Poor oral hygiene or gingival inflammation (Gingival Index > 1)
- Pregnant or lactating women
- Allergy or hypersensitivity to composite resins or dental adhesives
- Unable or unwilling to provide informed consent or comply with study visits
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Private Orthodontic Clinic - Kirkuk
Kirkuk, Kirkuk Governorate, Iraq
Actively Recruiting
2
Private Orthodontic Clinic - Kirkuk
Kirkuk, Province, Iraq
Not Yet Recruiting
Research Team
E
Elaf Hussein Hasan H Hasan, BSD
CONTACT
.
. Hadi Mohammad M Ismail, PHD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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