Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| MSc-Ortho-Aligner-Study-2025; | Other Identifier | College of Dentistry, University of Sulaimani; Research Ethics Committee, College of Dentistry, University of Sulaimani |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| flowable nanohybrid Composite Resin | Device | A flowable nanocomposite (e.g., GC aligne connect) used to fabricate clear aligner attachments on enamel surfaces for comparison |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elaf Hussein Hasan H Hasan, BSD | Contact | +9647715671612 | elafhussein9494@gmail.com | |
| . Hadi Mohammad M Ismail, PHD | Contact | +9647702106211 | hadi.ismail@univsul.edu.iq |
| Name | Affiliation | Role |
|---|---|---|
| Ali I Ibrahim | College of Dentistry, University of Sulaimani. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Private Orthodontic Clinic - Kirkuk | Recruiting | Kirkuk | Kirkuk Governorate | Iraq |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33848325 | Result | 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. |
Not provided
Not provided
ot applicable. Individual participant data will not be shared. Only summarized results will be published.
Not provided
Not provided
Not provided
Not provided
Not provided
Split-mouth randomized clinical trial in which each participant receives both interventions on opposite quadrants.
Not provided
Not provided
Single-blind design: the outcome assessor will be blinded to the type of composite used on each quadrant.
|
| Packable Microhybrid Composite Resin | Device | Packable microhybrid composite resin used to fabricate clear aligner attachments. |
|
| Private Orthodontic Clinic - Kirkuk | Not yet recruiting | Kirkuk | Province | Iraq |
|