MalocclusionNCT07352644
Factors Affecting Attachment Loss in Clear Aligner Treatment
A study testing Clear Aligners with Composite Attachments in people with Malocclusion and Crowded Teeth, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial summary
This prospective clinical study evaluated the incidence of composite attachment loss in patients undergoing clear aligner treatment and identified patient-, tooth-, and treatment-related factors associated with attachment debonding. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Malocclusion, Crowded Teeth, Attachment
- What is being tested?
- Clear Aligners with Composite Attachments
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 1 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Permanent dentition. Mild to moderate crowding. No history of previous orthodontic treatment with fixed appliances or clear aligners
Who cannot join
- Poor oral health. Bruxism. Crown restorations. Dental fluorosis. Enamel hypoplasia or other structural abnormalities affecting attachment bonding
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Factors Affecting Attachment Loss in Clear Aligner Treatment: A Prospective Clinical Study
This prospective clinical study evaluated the incidence of composite attachment loss in patients undergoing clear aligner treatment and identified patient-, tooth-, and treatment-related factors associated with attachment debonding. Twenty-one patients were followed for six months, and attachment failures were recorded at routine visits. Outcomes were compared according to attachment type (conventional vs. optimized), attachment size, tooth type, dental arch, and patient-related factors.
Read the detailed description
Composite attachments are integral to clear aligner therapy for improving force delivery, retention, and control of complex tooth movements. Despite their biomechanical importance, attachment loss remains a common clinical challenge and may compromise treatment efficiency and predictability. In this prospective study, attachments were bonded following the manufacturer's protocol using a high-viscosity composite. Patients were followed for six months, and attachment failures were documented with respect to type, size, tooth position, and patient-related behaviors. The primary objective was to determine the incidence of attachment loss and to identify factors associated with debonding, thereby contributing to clinical strategies that may reduce attachment failure and enhance treatment outcomes.
- Conditions
- Malocclusion, Crowded Teeth, Attachment
- Being tested
- Clear Aligners with Composite Attachments
- Keywords
- ATTACHMENT, ATTACHMENT LOSS, c, CLEAR ALIGNER TREATMENT
- Medical subject headings
- Malocclusion, Crowding
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clear Aligners with Composite AttachmentsDevice
Participants received clear aligner therapy (Invisalign®, Align Technology, San Jose, CA, USA). Composite attachments were bonded according to the manufacturer's protocol using a high-viscosity composite. Both conventional and optimized attachment types were used as part of the planned orthodontic treatment, and attachment loss was prospectively evaluated during a 6-month follow-up period.
| Study group | Role | What they receive |
|---|---|---|
| Clear Aligner Treatment | Experimental | Participants received clear aligner therapy (Invisalign®) with composite attachments bonded according to the manufacturer's protocol. Both conventional and optimized attachment types were used as part of the planned orthodontic treatment, and attachment loss was prospectively evaluated over a 6-month follow-up period. Receives: Device: Clear Aligners with Composite Attachments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Attachment Loss Rate
Proportion of composite attachments exhibiting complete detachment or partial debonding (irregular residual composite) during routine follow-up visits. Attachment loss was assessed by direct intraoral examination and tactile verification using a dental explorer.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2026
- Study start1 Jan 2022
- Primary completion1 Jun 2022
- Study completion1 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MalocclusionStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Şerife Şahin, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07352644
- Sponsor's protocol ID
- 2022/19
- Other IDs
- 2022/19
- Status last verified
- Jan 2026
- First submitted
- 12 Jan 2026
- Last updated
- 20 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Factors Affecting Attachment Loss in Clear Aligner Treatment: A Prospective Clinical Study
- ClinicalTrials.gov ID
- NCT07352644
- Acronym / sponsor ID
- 2022/19
- Conditions
- Malocclusion, Crowded Teeth, Attachment
- Keywords
- ATTACHMENT, ATTACHMENT LOSS, c, CLEAR ALIGNER TREATMENT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 1 Jun 2022 (actual)
- First posted
- 20 Jan 2026 (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 prospective clinical study evaluated the incidence of composite attachment loss in patients undergoing clear aligner treatment and identified patient-, tooth-, and treatment-related factors associated with attachment debonding. Twenty-one patients were followed for six months, and attachment failures were recorded at routine visits. Outcomes were compared according to attachment type (conventional vs. optimized), attachment size, tooth type, dental arch, and patient-related factors.
Detailed description
Composite attachments are integral to clear aligner therapy for improving force delivery, retention, and control of complex tooth movements. Despite their biomechanical importance, attachment loss remains a common clinical challenge and may compromise treatment efficiency and predictability. In this prospective study, attachments were bonded following the manufacturer's protocol using a high-viscosity composite. Patients were followed for six months, and attachment failures were documented with respect to type, size, tooth position, and patient-related behaviors. The primary objective was to determine the incidence of attachment loss and to identify factors associated with debonding, thereby contributing to clinical strategies that may reduce attachment failure and enhance treatment outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Clear Aligner Treatment | Experimental | Device: Clear Aligners with Composite AttachmentsParticipants received clear aligner therapy (Invisalign®) with composite attachments bonded according to the manufacturer's protocol. Both conventional and optimized attachment types were used as part of the planned orthodontic treatment, and attachment loss was prospectively evaluated over a 6-month follow-up period. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Permanent dentition. Mild to moderate crowding. No history of previous orthodontic treatment with fixed appliances or clear aligners
Key exclusion criteria (1 listed)
- Poor oral health. Bruxism. Crown restorations. Dental fluorosis. Enamel hypoplasia or other structural abnormalities affecting attachment bonding
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 |
|---|---|---|
| Clear Aligners with Composite AttachmentsParticipants received clear aligner therapy (Invisalign®, Align Technology, San Jose, CA, USA). Composite attachments were bonded according to the manufacturer's protocol using a high-viscosity composite. Both conventional and optimized attachment types were used as part of the planned orthodontic treatment, and attachment loss was prospectively evaluated during a 6-month follow-up period. | Device | Clear Aligner Treatment |
Primary outcome
Attachment Loss Rate
Time frame: 6 months
Proportion of composite attachments exhibiting complete detachment or partial debonding (irregular residual composite) during routine follow-up visits. Attachment loss was assessed by direct intraoral examination and tactile verification using a dental explorer.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clear Aligners with Composite Attachments in people with Malocclusion and Crowded Teeth, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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: finished, as of the sponsor's last update on 20 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attachment Loss Rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Jan 2026.