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

NCT ID: NCT07234149

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-15
• Study Completion Date: 2026-12-16

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.

Detailed Description

Clear aligner therapy has become a popular alternative to conventional fixed orthodontic appliances due to its superior esthetics and comfort. However, the efficiency of aligner treatment often depends on the proper use of composite attachments that enhance tooth movement and retention. Different composite resins are used for this purpose, but their optical stability and effect on enamel integrity after removal remain concerns.

This prospective, split-mouth randomized clinical trial compares a flowable nanocomposite and a packable microhybrid composite used for clear aligner attachments. Each participant will receive both materials in opposite quadrants to minimize inter-individual variability. Outcomes will include enamel color change (ΔE CIE Lab* values), bonding/debonding time, and surface roughness assessment using digital and optical analysis methods.

The study hypothesis is that the flowable nanocomposite will exhibit superior color stability and faster handling time, with comparable enamel surface effects to the packable composite. Results from this trial may help establish standardized protocols for attachment material selection in clinical orthodontic practice.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

packable microcomposite (Group A)

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

Group Type: EXPERIMENTAL

Packable Microhybrid Composite Resin

Intervention Type: DEVICE

Packable microhybrid composite resin used to fabricate clear aligner attachments.

flowable nanohybrid Composite (Group B)

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.

Group Type: ACTIVE_COMPARATOR

flowable nanohybrid Composite Resin

Intervention Type: DEVICE

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

Interventions

flowable nanohybrid Composite Resin

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

Intervention Type: DEVICE

Packable Microhybrid Composite Resin

Packable microhybrid composite resin used to fabricate clear aligner attachments.

Intervention Type: DEVICE

Other Intervention Names

packable microhybrid composite

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Sulaimani

OTHER

Sponsor Role: lead

Responsible Party

Elaf Hussein Hasan

MSc Student in Orthodontics

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ali I Ibrahim

Role: PRINCIPAL_INVESTIGATOR

College of Dentistry, University of Sulaimani.

Locations

Private Orthodontic Clinic - Kirkuk

Kirkuk, Kirkuk Governorate, Iraq

Site Status: RECRUITING

Private Orthodontic Clinic - Kirkuk

Kirkuk, Province, Iraq

Site Status: NOT_YET_RECRUITING

Countries

Iraq

Central Contacts

Elaf Hussein Hasan H Hasan, BSD

Role: CONTACT

elafhussein9494@gmail.com

+9647715671612

. Hadi Mohammad M Ismail, PHD

Role: CONTACT

hadi.ismail@univsul.edu.iq

+9647702106211

Facility Contacts

Elaf H Hasan, BSD,MSD candidate

Role: primary

elafhussein9494@gmail.com

+9647715671612

Elaf H Hasan, BSD,MSD candidate

Role: primary

elafhussein9494@gmail.com

+9647715671612

Hadi M Ismail, PHD

Role: backup

hadi.ismail@univsul.edu.iq

+9647702106211

References

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.

Reference Type: RESULT

PMID: 33848325 (View on PubMed)

Other Identifiers

MSc-Ortho-Aligner-Study-2025;

Identifier Type: OTHER

Identifier Source: secondary_id

USulaimani-Ortho-Aligner-2025

Identifier Type: -

Identifier Source: org_study_id