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

NCT07234149 | Recruiting

• 2 other identifiers: USulaimani-Ortho-Aligner-2025MSc-Ortho-Aligner-Study-2025;
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Composite Attachment Flowable Nanocomposite Packable Microhybrid Composite

Outcome Measures

Primary Outcomes (1)

• Change in Tooth Color (ΔE) After Attachment Removal

  The color change (ΔE) of the enamel surface will be measured using a VITA Easyshade spectrophotometer based on CIE Lab\* values before bonding and after debonding of the attachments. A ΔE value ≥ 3.3 will be considered clinically perceptible.

  Baseline (before bonding) and after attachment removal

Study Arms (2)

packable microcomposite (Group A)

EXPERIMENTAL

Participants will receive packable microcomposite attachments (e.g., GC G-ænial Universal ) on one side of the dental arc attachments on one quadrant of the dental arch for clear aligner therapy. Color change, bonding/debonding time, and enamel roughness will be assessed

Device: Packable Microhybrid Composite Resin

flowable nanohybrid Composite (Group B)

ACTIVE COMPARATOR

Participants will receive flowable nanocomposite (e.g., GC aligner connect ) attachments on the opposite quadrant of the same dental arch.Color change, bonding/debonding time, and enamel roughness will be assessed.

Device: flowable nanohybrid Composite Resin

Interventions

flowable nanohybrid Composite Resin DEVICE

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

Also known as: packable microhybrid composite

flowable nanohybrid Composite (Group B)

Packable Microhybrid Composite Resin DEVICE

Packable microhybrid composite resin used to fabricate clear aligner attachments.

packable microcomposite (Group A)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• University of Sulaimani: lead

Study Sites (2)

Private Orthodontic Clinic - Kirkuk

Kirkuk, Kirkuk Governorate, Iraq

RECRUITING

Private Orthodontic Clinic - Kirkuk

Kirkuk, Province, Iraq

NOT YET RECRUITING

Related Publications (1)

• Lin S, Huang L, Li J, Wen J, Mei L, Xu H, Zhang L, Li H. Assessment of preparation time and 1-year Invisalign aligner attachment survival using flowable and packable composites. Angle Orthod. 2021 Sep 1;91(5):583-589. doi: 10.2319/063020-598.1.

  PMID: 33848325 RESULT

Study Officials

• Ali I Ibrahim

  College of Dentistry, University of Sulaimani.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elaf Hussein Hasan H Hasan, BSD

CONTACT

+9647715671612; elafhussein9494@gmail.com

. Hadi Mohammad M Ismail, PHD

CONTACT

+9647702106211; hadi.ismail@univsul.edu.iq

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single-blind design: the outcome assessor will be blinded to the type of composite used on each quadrant.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MSc Student in Orthodontics

Model Details: Split-mouth randomized clinical trial in which each participant receives both interventions on opposite quadrants.

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 18, 2025
• Study Start: October 15, 2025
• Primary Completion (Estimated): July 15, 2026
• Study Completion (Estimated): December 16, 2026
• Last Updated: November 18, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IR (2)