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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

NCT07234149 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-11-18

No results posted yet for this study

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.

Conditions

  • Clear Aligner Orthodontic Treatment
  • Composite Attachment
  • Color Stability of Enamel

Interventions

DEVICE

flowable nanohybrid Composite Resin

A flowable nanocomposite (e.g., GC aligne connect) used to fabricate clear aligner attachments on enamel surfaces for comparison

DEVICE

Packable Microhybrid Composite Resin

Packable microhybrid composite resin used to fabricate clear aligner attachments.

Sponsors & Collaborators

  • University of Sulaimani

    lead OTHER

Principal Investigators

  • Ali I Ibrahim · College of Dentistry, University of Sulaimani.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2025-10-15
Primary Completion
2026-07-15
Completion
2026-12-16

Countries

  • Iraq

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07234149 on ClinicalTrials.gov