Clear Aligner Orthodontic TreatmentNCT07234149
Tooth Discoloration and Chairside Handling Time (Bonding-Debonding) in Flowable Versus Packable Composites for Clear Aligner Bonded Attachments: A Randomized Clinical Trial
A study testing flowable nanohybrid Composite Resin and Packable Microhybrid Composite Resin in people with Clear Aligner Orthodontic Treatment and Composite Attachment, run by University of Sulaimani at 2 sites in Iraq.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Clear Aligner Orthodontic Treatment, Composite Attachment, Color Stability of Enamel
- What is being tested?
- flowable nanohybrid Composite Resin and Packable Microhybrid Composite Resin
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 2 sitesIraq
- Study dates
- 15 Oct 2025to 16 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Iraq2 sites, 2 recruiting
- Recruiting
Private Orthodontic Clinic - Kirkuk
Kirkuk, Kirkuk Governorate
Elaf H Hasan, BSD,MSD candidate, +9647715671612, elafhussein9494@gmail.com
- Not yet recruiting
Private Orthodontic Clinic - Kirkuk
Kirkuk, Province
Elaf H Hasan, BSD,MSD candidate, +9647715671612, elafhussein9494@gmail.com
Hadi M Ismail, PHD, +9647702106211, hadi.ismail@univsul.edu.iq
About this study
Official title: Comparison of Color Stability, Bonding Time, and White Spot Lesion Between Flowable Nanocomposite and Packable Microhybrid Composite Used for Clear Aligner Attachments: A Split-Mouth Randomized Clinical Trial
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.
Read the 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.
- Being tested
- flowable nanohybrid Composite Resin, Packable Microhybrid Composite Resin
- Keywords
- Composite Attachment Flowable Nanocomposite Packable Microhybrid Composite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
flowable nanohybrid Composite ResinDevice
Also called packable microhybrid composite
A flowable nanocomposite (e.g., GC aligne connect) used to fabricate clear aligner attachments on enamel surfaces for comparison
Packable Microhybrid Composite ResinDevice
Packable microhybrid composite resin used to fabricate clear aligner attachments.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Device: flowable nanohybrid Composite Resin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline (before bonding) and after attachment removal
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2025
- Study start15 Oct 2025
- Primary completion15 Jul 2026 (estimated)
- Study completion16 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clear Aligner Orthodontic TreatmentStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Split-mouth randomized clinical trial in which each participant receives both interventions on opposite quadrants.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sulaimani
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elaf Hussein Hasan, Ministry of Health, Iraq
- Investigators
- Ali I Ibrahim, Principal investigator, College of Dentistry, University of Sulaimani.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07234149
- Sponsor's protocol ID
- USulaimani-Ortho-Aligner-2025
- Other IDs
- MSc-Ortho-Aligner-Study-2025;
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 18 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: ot applicable. Individual participant data will not be shared. Only summarized results will be published.
Publications
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.
PubMed 33848325
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Color Stability, Bonding Time, and White Spot Lesion Between Flowable Nanocomposite and Packable Microhybrid Composite Used for Clear Aligner Attachments: A Split-Mouth Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07234149
- Acronym / sponsor ID
- USulaimani-Ortho-Aligner-2025
- Keywords
- Composite Attachment Flowable Nanocomposite Packable Microhybrid Composite
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University of SulaimaniUniversity, hospital or other
- Study start
- 15 Oct 2025 (actual)
- Primary completion
- 15 Jul 2026 (estimated)
- Study completion
- 16 Dec 2026 (estimated)
- First posted
- 18 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Split-mouth randomized clinical trial in which each participant receives both interventions on opposite quadrants.
| Arm | Type | Receives |
|---|---|---|
| packable microcomposite (Group A) | Experimental | Device: Packable Microhybrid Composite ResinParticipants 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 | Device: flowable nanohybrid Composite ResinParticipants 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| flowable nanohybrid Composite ResinAlso: packable microhybrid compositeA flowable nanocomposite (e.g., GC aligne connect) used to fabricate clear aligner attachments on enamel surfaces for comparison | Device | flowable nanohybrid Composite (Group B) |
| Packable Microhybrid Composite ResinPackable microhybrid composite resin used to fabricate clear aligner attachments. | Device | packable microcomposite (Group A) |
Primary outcome
Change in Tooth Color (ΔE) After Attachment Removal
Time frame: Baseline (before bonding) and 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2025.
- Results publication: PubMed 33848325Lin 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.
- Individual participant dataSharing planned: No. ot applicable. Individual participant data will not be shared. Only summarized results will be published.
Related trials for Clear Aligner Orthodontic Treatment
RecruitingObservational study
Clinical Evaluation of Customized Attachment Composites in Clear Aligner Therapy
Clear Aligner Therapy, Aligner Attachment Wear
Not yet recruiting
Salivary Flow, pH, and Buffering Capacity in Fixed and Clear Aligner Orthodontic Treatment
Orthodontic Treatment, Saliva
Not yet recruiting
Orthodontic Treatment Outcomes of Self Ligating System Compared to Clear Aligner System
Angle Class I Maloclussion, Dental Crowding
Active, not recruiting
Impact of Lingual Attachment on WSL Development in Clear Aligner Patients: A Randomized Controlled Clinical Trial
White Spot Lesion of Tooth
Enrolling by invitation
Split-Mouth Comparison of Invisalign Attachments
Wear, Restoration, Volume Assessment
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ali I Ibrahim principal investigator
College of Dentistry, University of Sulaimani.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing flowable nanohybrid Composite Resin and Packable Microhybrid Composite Resin in people with Clear Aligner Orthodontic Treatment and Composite Attachment, run by University of Sulaimani at 2 sites in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iraq. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Elaf Hussein Hasan H Hasan, BSD (+9647715671612, elafhussein9494@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Tooth Color (ΔE) After Attachment Removal (time frame: Baseline (before bonding) and after attachment removal). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07234149, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2025.