Clear Aligner TherapyNCT07726485
Evaluation of the Effect of Aligner Seaters on the Predictability of Tooth Movement in Clear Aligner Therapy.
A study testing Aligner seater in people with Clear Aligner Therapy and Malocclusions, run by University of Baghdad at 1 site in Iraq.
Trial summary
The goal of clinical trial is to know the role clear aligner seater. The main question it aims to answer is to evaluate the use of clear aligner seater on the effectiveness of clear aligner therapy by questioning the predictability of proposed treatment plan. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Clear Aligner Therapy, Malocclusions
- What is being tested?
- Aligner seater
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteIraq
- Study dates
- 16 Feb 2026to Sep 2027
- 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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female participants.
- Age between 18 and 45 years.
- Mild to moderate crowding or spacing.
- ANB angle between 1° and 5°.
- Planned for non-extraction clear aligner treatment.
- Willing and able to provide written informed consent and comply with the study protocol.
Who cannot join
- Craniofacial syndromes (e.g., cleft lip and/or palate) or other congenital craniofacial anomalies.
- Severe crowding.
- Signs and/or symptoms of temporomandibular disorders (TMD).
- Previous orthodontic treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effect of Aligner Seaters on the Predictability of Tooth Movement in Clear Aligner Therapy: A Randomized Clinical Trial
The goal of clinical trial is to know the role clear aligner seater. The main question it aims to answer is to evaluate the use of clear aligner seater on the effectiveness of clear aligner therapy by questioning the predictability of proposed treatment plan.
- Group A (Regular-use group): Use chewy with the 1st insertion of each aligner sets for a day or a couple of days until the aligner seated well with no gap with the teeth. The patients will be instructed to bite on the chewy while the aligners are in position for few seconds.
- Group B (customized-use group): In addition to the regular use of the chewy, the participants will be instructed to bite for few seconds while the aligners are in their mouth at bedtime on a daily bases.
Read the detailed description
A single-operator, multi-center randomized controlled trial (RCT) with a 1:1 allocation ratio will be conducted among patients seeking orthodontic treatment with clear aligner therapy. The study will take place at the Postgraduate Orthodontic Clinic, College of Dentistry, University of Baghdad, Baghdad, Iraq. Eligible participants will be randomly assigned to one of two aligner seater (chewy) use protocols. To minimize inter-operator variability, all participants will be treated by the same orthodontist.
A standardized clinical protocol will be followed. Each participant will undergo extraoral and intraoral photography, intraoral scanning using the Medit i700 scanner (Medit Corp., Seoul, South Korea), and radiographic assessment including cone-beam computed tomography (CBCT) and lateral cephalometric radiography.
On the day of aligner insertion, gingival index and plaque index will be recorded. The teeth will be isolated and cleaned with a water-pumice slurry using a rubber polishing cup mounted on a low-speed handpiece. The enamel surfaces will be rinsed and dried with oil-free compressed air, followed by conventional acid etching with 37% phosphoric acid for 30 seconds. The etched surfaces will then be rinsed for 10 seconds according to the manufacturer's instructions and air-dried until a frosty white appearance is observed.
A universal adhesive (BISCO All-BOND UNIVERSAL, USA) will be applied to the etched enamel surfaces using a nylon brush, followed by gentle air thinning for 2 seconds with the air stream directed perpendicular to the enamel surface. Attachment templates will be filled with Neo Spectra™ ST Universal Composite (Dentsply Sirona), a nanohybrid composite material, and attachments will be bonded according to the aligner manufacturer's prescribed attachment positions. The composite will then be light-cured for 20 seconds.
Group A (Regular-use group): Participants will use the aligner seater during the initial insertion of each new aligner for one to two days, or until the aligner is fully seated without visible gaps. Participants will be instructed to bite on the aligner seater for a few seconds while the aligner is in place.
Group B (Customized-use group): In addition to the regular-use protocol described for Group A, participants will be instructed to bite on the aligner seater for a few seconds each night at bedtime throughout the study period.
All participants will receive standardized written instructions regarding clear aligner care and the manufacturer's recommendations. A study-specific questionnaire will be completed to assess pain during treatment. Participants will attend follow-up visits every 30 days (after every three aligners), during which gingival index, plaque index, intraoral photographs, digital intraoral scans, and questionnaire data will be collected. Participants will also be instructed to contact the treating orthodontist immediately if attachment loss occurs.
Participants will be followed for four months.
- Conditions
- Clear Aligner Therapy, Malocclusions
- Being tested
- Aligner seater
- Keywords
- Clear aligner therapy, Clear Aligner Seater
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aligner seaterDevice
Participants use silicone aligner seaters during clear aligner therapy. The study compares two different protocols of aligner seater use: regular use and customize use.
| Study group | Role | What they receive |
|---|---|---|
| Regular-use of chewy group | Active comparator | Use chewy with the 1st insertion of each aligner sets for a day or a couple of days until the aligner seated well with no gap with the teeth. The patients will be instructed to bite on the chewy while the aligners are in position for few seconds Receives: Device: Aligner seater |
| Customized-use of chewy group | Experimental | In addition to the regular use of the chewy, the participants will be instructed to bite for few seconds while the aligners are in their mouth at bedtime on a daily bases. Receives: Device: Aligner seater |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary outcome measure
Tooth movement predictability will be assessed as the absolute difference between the prescribed and achieved tooth movement in linear (mm) and angular (degrees) measurements using three-dimensional digital model superimposition. Digital models will be analyzed using Geomagic Control X software.
Measured: Four months
Secondary outcomes (2)
Pain during clear aligner therapy
Pain intensity will be assessed using a Visual Analog Scale (VAS) questionnaire at 1 hour, 6 hours, 2 days, 5 days, and 7 days after insertion of first aligner.
Measured: 1 hour, 6 hours, 2 days, 5 days, and 7 days after insertion of first aligner.
Periodontal health
Periodontal health will be assessed using the Bleeding on Probing (BOP) index and the Plaque Index (PI).
Measured: Baseline and every monthly follow-up visit throughout the 4-month study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2026
- Study start16 Feb 2026
- Primary completionAug 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clear Aligner TherapyStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farah Alaa Hussein, University of Baghdad
- Investigators
- Farah Alaa Hussein, B.D.S., Principal investigator, University of Baghdad/ collage of DentistryHadeel Adel Al-lami, Ph.D orthodontics, Study director, University of Baghdad/ collage of Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07726485
- Sponsor's protocol ID
- 1105425
- Status last verified
- Jul 2026
- First submitted
- 22 Jun 2026
- Last updated
- 24 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Aligner Seaters on the Predictability of Tooth Movement in Clear Aligner Therapy: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07726485
- Acronym / sponsor ID
- 1105425
- Conditions
- Clear Aligner Therapy, Malocclusions
- Keywords
- Clear aligner therapy, Clear Aligner Seater
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 16 Feb 2026 (actual)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 24 Jul 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.
The goal of clinical trial is to know the role clear aligner seater. The main question it aims to answer is to evaluate the use of clear aligner seater on the effectiveness of clear aligner therapy by questioning the predictability of proposed treatment plan.
- Group A (Regular-use group): Use chewy with the 1st insertion of each aligner sets for a day or a couple of days until the aligner seated well with no gap with the teeth. The patients will be instructed to bite on the chewy while the aligners are in position for few seconds.
- Group B (customized-use group): In addition to the regular use of the chewy, the participants will be instructed to bite for few seconds while the aligners are in their mouth at bedtime on a daily bases.
Detailed description
A single-operator, multi-center randomized controlled trial (RCT) with a 1:1 allocation ratio will be conducted among patients seeking orthodontic treatment with clear aligner therapy. The study will take place at the Postgraduate Orthodontic Clinic, College of Dentistry, University of Baghdad, Baghdad, Iraq. Eligible participants will be randomly assigned to one of two aligner seater (chewy) use protocols. To minimize inter-operator variability, all participants will be treated by the same orthodontist.
A standardized clinical protocol will be followed. Each participant will undergo extraoral and intraoral photography, intraoral scanning using the Medit i700 scanner (Medit Corp., Seoul, South Korea), and radiographic assessment including cone-beam computed tomography (CBCT) and lateral cephalometric radiography.
On the day of aligner insertion, gingival index and plaque index will be recorded. The teeth will be isolated and cleaned with a water-pumice slurry using a rubber polishing cup mounted on a low-speed handpiece. The enamel surfaces will be rinsed and dried with oil-free compressed air, followed by conventional acid etching with 37% phosphoric acid for 30 seconds. The etched surfaces will then be rinsed for 10 seconds according to the manufacturer's instructions and air-dried until a frosty white appearance is observed.
A universal adhesive (BISCO All-BOND UNIVERSAL, USA) will be applied to the etched enamel surfaces using a nylon brush, followed by gentle air thinning for 2 seconds with the air stream directed perpendicular to the enamel surface. Attachment templates will be filled with Neo Spectra™ ST Universal Composite (Dentsply Sirona), a nanohybrid composite material, and attachments will be bonded according to the aligner manufacturer's prescribed attachment positions. The composite will then be light-cured for 20 seconds.
Group A (Regular-use group): Participants will use the aligner seater during the initial insertion of each new aligner for one to two days, or until the aligner is fully seated without visible gaps. Participants will be instructed to bite on the aligner seater for a few seconds while the aligner is in place.
Group B (Customized-use group): In addition to the regular-use protocol described for Group A, participants will be instructed to bite on the aligner seater for a few seconds each night at bedtime throughout the study period.
All participants will receive standardized written instructions regarding clear aligner care and the manufacturer's recommendations. A study-specific questionnaire will be completed to assess pain during treatment. Participants will attend follow-up visits every 30 days (after every three aligners), during which gingival index, plaque index, intraoral photographs, digital intraoral scans, and questionnaire data will be collected. Participants will also be instructed to contact the treating orthodontist immediately if attachment loss occurs.
Participants will be followed for four months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular-use of chewy group | Active comparator | Device: Aligner seaterUse chewy with the 1st insertion of each aligner sets for a day or a couple of days until the aligner seated well with no gap with the teeth. The patients will be instructed to bite on the chewy while the aligners are in position for few seconds |
| Customized-use of chewy group | Experimental | Device: Aligner seaterIn addition to the regular use of the chewy, the participants will be instructed to bite for few seconds while the aligners are in their mouth at bedtime on a daily bases. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male and female participants.
- Age between 18 and 45 years.
- Mild to moderate crowding or spacing.
- ANB angle between 1° and 5°.
- Planned for non-extraction clear aligner treatment.
Key exclusion criteria (4 listed)
- Craniofacial syndromes (e.g., cleft lip and/or palate) or other congenital craniofacial anomalies.
- Severe crowding.
- Signs and/or symptoms of temporomandibular disorders (TMD).
- Previous orthodontic treatment.
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 |
|---|---|---|
| Aligner seaterParticipants use silicone aligner seaters during clear aligner therapy. The study compares two different protocols of aligner seater use: regular use and customize use. | Device | Customized-use of chewy group, Regular-use of chewy group |
Primary outcome
Primary outcome measure
Time frame: Four months
Tooth movement predictability will be assessed as the absolute difference between the prescribed and achieved tooth movement in linear (mm) and angular (degrees) measurements using three-dimensional digital model superimposition. Digital models will be analyzed using Geomagic Control X software.
2 secondary outcomes
Pain during clear aligner therapy
Time frame: 1 hour, 6 hours, 2 days, 5 days, and 7 days after insertion of first aligner.
Periodontal health
Time frame: Baseline and every monthly follow-up visit throughout the 4-month study period
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 24 Jul 2026.
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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.
Farah Alaa Hussein, B.D.S. principal investigator
University of Baghdad/ collage of Dentistry
Hadeel Adel Al-lami, Ph.D orthodontics study director
University of Baghdad/ collage of Dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aligner seater in people with Clear Aligner Therapy and Malocclusions, run by University of Baghdad at 1 site 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 6 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 24 Jul 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 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?
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?
Primary outcome measure (time frame: Four 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 24 Jul 2026.