Cleft Lip and PalateNCT07916766
Customized Differential Palatal Expansion in Children With Cleft Lip and Palate
A study testing Custom-Designed Palatal-Coverage Thermoplastic Aligner in people with Cleft Lip and Palate, run by Marmara University at 1 site in Turkey (Türkiye).
Trial summary
The aim of this study was to establish a novel approach to maxillary expansion using clear aligners in individuals with cleft lip and palate during the mixed dentition period and to explore its applicability in routine clinical practice. Read more about this study
- Who is it for?
- Ages 6 to 9 years
- Conditions the study is for
- Cleft Lip and Palate
- What is being tested?
- Custom-Designed Palatal-Coverage Thermoplastic Aligner
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 7 May 2024to 23 Mar 2026
- 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 6 to 9 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children aged 6-9 years at the time of study enrollment.
- Patients with nonsyndromic cleft lip and palate in the mixed dentition stage.
- Patients requiring maxillary expansion.
- No previous orthodontic treatment or maxillary expansion.
- Adequate dental support for the application of the expansion appliance.
- No systemic disease affecting orthodontic treatment.
Who cannot join
- Patients outside the specified age range at enrollment.
- Patients with syndromic cleft lip and palate.
- Patients with systemic diseases affecting orthodontic treatment.
- Patients who had previously undergone orthodontic treatment or maxillary expansion.
- Insufficient dental support or inadequate clinical crown height for appliance retention.
- Patients in the late mixed dentition stage requiring maxillary protraction with facemask therapy.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara University, Faculty of Dentistry, Department of Orthodontics
Istanbul, Istanbul, 34854
About this study
Official title: Dentoalveolar Effects Of Slow Maxillary Expansion With Removable Thermoplastic Aligners In Children With Cleft Lip And Palate
The aim of this study was to establish a novel approach to maxillary expansion using clear aligners in individuals with cleft lip and palate during the mixed dentition period and to explore its applicability in routine clinical practice. The proposed treatment modality was designed with the intention of improving patient comfort, facilitating oral hygiene, and maintaining oral health during the expansion process.
Eight children with cleft lip and palate, aged 7-9 years, underwent individualized maxillary expansion using a novel, custom-designed thermoplastic appliance developed by the research team. Unlike conventional clear aligners, the appliance extended over the palatal region and was designed to facilitate controlled, differential maxillary expansion through a fully digital workflow.
Three-dimensional digital dental models obtained before and after treatment were used to evaluate changes in maxillary arch dimensions, palatal volume, and tooth inclinations. Additionally, the accuracy of the treatment approach was assessed by comparing the digitally planned expansion with the clinically achieved expansion.
Read the detailed description
A total of eight patients (n = 8) with cleft lip and palate in the mixed dentition stage who required maxillary expansion were included in this study.
Digital impressions were obtained using a three-dimensional intraoral scanner and converted into STL files. The digital models were imported into NemoStudio software, where the maxillary segments were digitally separated according to the cleft line and repositioned to achieve the planned expansion and correction of arch form deformities.
A custom-designed thermoplastic aligner system developed by the research team was used. The aligner design incorporated the palatal region to facilitate controlled and differential maxillary expansion. Sequential digital models were generated using 0.25-mm activation increments, and the final digital setups were transferred to a three-dimensional printing workflow for the fabrication of thermoplastic aligners. Patients wore the aligners sequentially, with each aligner used for 5-7 days.
Transverse dimensions, dental arch measurements, palatal volume, palatal depth, and tooth inclination changes were assessed using digital models obtained immediately before expansion and 0-2 months after treatment. Additionally, the accuracy of the expansion protocol was evaluated by comparing the planned and achieved transverse expansion at the canine and molar levels.
- Conditions
- Cleft Lip and Palate
- Being tested
- Custom-Designed Palatal-Coverage Thermoplastic Aligner
- Keywords
- Maxillary Expansion, Clear Aligner Appliance, Mixed Dentition, Differential Expansion, Digital Orthodontics
- Medical subject headings
- Cleft Lip
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Custom-Designed Palatal-Coverage Thermoplastic AlignerDevice
A custom-designed thermoplastic aligner appliance incorporating the palatal region was developed by the research team for individualized maxillary expansion in children with cleft lip and palate. Three-dimensional digital models were used to segment the maxillary arch along the cleft line and plan differential expansion movements according to each patient's transverse deficiency. Sequential appliances were fabricated using digitally planned 0.25-mm activation increments and worn for 5-7 days per stage.
| Study group | Role | What they receive |
|---|---|---|
| Customized Differential Maxillary Expansion | Experimental | Eight children with cleft lip and palate in the mixed dentition period received individualized maxillary expansion using a custom-designed thermoplastic aligner appliance incorporating the palatal region. Expansion movements were digitally planned according to each patient's transverse maxillary deficiency. Receives: Device: Custom-Designed Palatal-Coverage Thermoplastic Aligner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maxillary Intercanine Width
Changes in maxillary intercanine width were assessed at the canine cusp tip and gingival levels using pretreatment and posttreatment three-dimensional digital dental models. Measurements were recorded in millimeters (mm).
Measured: Baseline and immediately after treatment completion
Change in Maxillary Intermolar Width
Changes in maxillary intermolar width were assessed at the molar cusp tip and gingival levels using pretreatment and posttreatment three-dimensional digital dental models. Measurements were recorded in millimeters (mm).
Measured: Baseline and immediately after treatment completion
Change in Mandibular Intercanine and Intermolar Widths
Changes in mandibular intercanine and intermolar widths were assessed using pretreatment and posttreatment three-dimensional digital dental models. Measurements were recorded in millimeters (mm).
Measured: Baseline and immediately after treatment completion
Change in Maxillary Arch Perimeter
Changes in maxillary arch perimeter were assessed by comparing pretreatment and posttreatment three-dimensional digital dental models. Measurements were recorded in millimeters (mm).
Measured: Baseline and immediately after treatment completion
Change in Maxillary Arch Length
Changes in maxillary arch length were assessed by comparing pretreatment and posttreatment three-dimensional digital dental models. Measurements were recorded in millimeters (mm).
Measured: Baseline and immediately after treatment completion
Change in Palatal Volume
Changes in palatal volume were assessed by comparing pretreatment and posttreatment three-dimensional digital maxillary models. Measurements were recorded in cubic millimeters (mm³).
Measured: Baseline and immediately after treatment completion
Change in Palatal Depth
Changes in palatal depth were assessed by comparing pretreatment and posttreatment three-dimensional digital maxillary models. Palatal depth was measured as the perpendicular distance from a line connecting the midpoints of the lingual gingival margins of the maxillary first molars to the deepest point of the palate. Measurements were recorded in millimeters (mm).
Measured: Baseline and immediately after treatment completion
Change in Buccolingual Tooth Inclinations
Changes in the buccolingual inclinations of maxillary teeth were assessed by comparing pretreatment and posttreatment three-dimensional digital dental models. Measurements were recorded in degrees (°).
Measured: Baseline and immediately after treatment completion
Secondary outcomes (1)
Predictability of Digitally Planned Maxillary Expansion
The predictability of maxillary expansion was evaluated by comparing the digitally planned and clinically achieved expansion amounts at the canine and molar levels using three-dimensional digital models. Predictability was expressed as the percentage of achieved expansion relative to the planned expansion.
Measured: Baseline and immediately after treatment completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start7 May 2024
- Primary completion23 Mar 2026
- Study completion23 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cleft Lip and PalateStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yasemin B Acar, Associate Professor, Principal investigator, Department of Orthodontics, Faculty of Dentistry, Marmara UniversityElif A Öztürk, DDS, PhD, Study director, Marmara University, Institute of Health Sciences, Department of Orthodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07916766
- Sponsor's protocol ID
- 09.2024.525
- Other IDs
- 11870
- Status last verified
- Oct 2026
- First submitted
- 30 Oct 2026
- Last updated
- 4 Nov 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 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dentoalveolar Effects Of Slow Maxillary Expansion With Removable Thermoplastic Aligners In Children With Cleft Lip And Palate
- ClinicalTrials.gov ID
- NCT07916766
- Acronym / sponsor ID
- 09.2024.525
- Conditions
- Cleft Lip and Palate
- Keywords
- Maxillary Expansion, Clear Aligner Appliance, Mixed Dentition, Differential Expansion, Digital Orthodontics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 7 May 2024 (actual)
- Primary completion
- 23 Mar 2026 (actual)
- Study completion
- 23 Mar 2026 (actual)
- First posted
- 4 Nov 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 aim of this study was to establish a novel approach to maxillary expansion using clear aligners in individuals with cleft lip and palate during the mixed dentition period and to explore its applicability in routine clinical practice. The proposed treatment modality was designed with the intention of improving patient comfort, facilitating oral hygiene, and maintaining oral health during the expansion process.
Eight children with cleft lip and palate, aged 7-9 years, underwent individualized maxillary expansion using a novel, custom-designed thermoplastic appliance developed by the research team. Unlike conventional clear aligners, the appliance extended over the palatal region and was designed to facilitate controlled, differential maxillary expansion through a fully digital workflow.
Three-dimensional digital dental models obtained before and after treatment were used to evaluate changes in maxillary arch dimensions, palatal volume, and tooth inclinations. Additionally, the accuracy of the treatment approach was assessed by comparing the digitally planned expansion with the clinically achieved expansion.
Detailed description
A total of eight patients (n = 8) with cleft lip and palate in the mixed dentition stage who required maxillary expansion were included in this study.
Digital impressions were obtained using a three-dimensional intraoral scanner and converted into STL files. The digital models were imported into NemoStudio software, where the maxillary segments were digitally separated according to the cleft line and repositioned to achieve the planned expansion and correction of arch form deformities.
A custom-designed thermoplastic aligner system developed by the research team was used. The aligner design incorporated the palatal region to facilitate controlled and differential maxillary expansion. Sequential digital models were generated using 0.25-mm activation increments, and the final digital setups were transferred to a three-dimensional printing workflow for the fabrication of thermoplastic aligners. Patients wore the aligners sequentially, with each aligner used for 5-7 days.
Transverse dimensions, dental arch measurements, palatal volume, palatal depth, and tooth inclination changes were assessed using digital models obtained immediately before expansion and 0-2 months after treatment. Additionally, the accuracy of the expansion protocol was evaluated by comparing the planned and achieved transverse expansion at the canine and molar levels.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Customized Differential Maxillary Expansion | Experimental | Device: Custom-Designed Palatal-Coverage Thermoplastic AlignerEight children with cleft lip and palate in the mixed dentition period received individualized maxillary expansion using a custom-designed thermoplastic aligner appliance incorporating the palatal region. Expansion movements were digitally planned according to each patient's transverse maxillary deficiency. |
Who may qualify
- Ages
- 6 to 9 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Children aged 6-9 years at the time of study enrollment.
- Patients with nonsyndromic cleft lip and palate in the mixed dentition stage.
- Patients requiring maxillary expansion.
- No previous orthodontic treatment or maxillary expansion.
- Adequate dental support for the application of the expansion appliance.
Key exclusion criteria (6 listed)
- Patients outside the specified age range at enrollment.
- Patients with syndromic cleft lip and palate.
- Patients with systemic diseases affecting orthodontic treatment.
- Patients who had previously undergone orthodontic treatment or maxillary expansion.
- Insufficient dental support or inadequate clinical crown height for appliance retention.
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 |
|---|---|---|
| Custom-Designed Palatal-Coverage Thermoplastic AlignerA custom-designed thermoplastic aligner appliance incorporating the palatal region was developed by the research team for individualized maxillary expansion in children with cleft lip and palate. Three-dimensional digital models were used to segment the maxillary arch along the cleft line and plan differential expansion movements according to each patient's transverse deficiency. Sequential appliances were fabricated using digitally planned 0.25-mm activation increments and worn for 5-7 days per stage. | Device | Customized Differential Maxillary Expansion |
Primary outcome
Change in Maxillary Intercanine Width
Time frame: Baseline and immediately after treatment completion
Changes in maxillary intercanine width were assessed at the canine cusp tip and gingival levels using pretreatment and posttreatment three-dimensional digital dental models. Measurements were recorded in millimeters (mm).
Change in Maxillary Intermolar Width
Time frame: Baseline and immediately after treatment completion
Changes in maxillary intermolar width were assessed at the molar cusp tip and gingival levels using pretreatment and posttreatment three-dimensional digital dental models. Measurements were recorded in millimeters (mm).
Change in Mandibular Intercanine and Intermolar Widths
Time frame: Baseline and immediately after treatment completion
Changes in mandibular intercanine and intermolar widths were assessed using pretreatment and posttreatment three-dimensional digital dental models. Measurements were recorded in millimeters (mm).
Change in Maxillary Arch Perimeter
Time frame: Baseline and immediately after treatment completion
Changes in maxillary arch perimeter were assessed by comparing pretreatment and posttreatment three-dimensional digital dental models. Measurements were recorded in millimeters (mm).
Change in Maxillary Arch Length
Time frame: Baseline and immediately after treatment completion
Changes in maxillary arch length were assessed by comparing pretreatment and posttreatment three-dimensional digital dental models. Measurements were recorded in millimeters (mm).
Change in Palatal Volume
Time frame: Baseline and immediately after treatment completion
Changes in palatal volume were assessed by comparing pretreatment and posttreatment three-dimensional digital maxillary models. Measurements were recorded in cubic millimeters (mm³).
Change in Palatal Depth
Time frame: Baseline and immediately after treatment completion
Changes in palatal depth were assessed by comparing pretreatment and posttreatment three-dimensional digital maxillary models. Palatal depth was measured as the perpendicular distance from a line connecting the midpoints of the lingual gingival margins of the maxillary first molars to the deepest point of the palate. Measurements were recorded in millimeters (mm).
Change in Buccolingual Tooth Inclinations
Time frame: Baseline and immediately after treatment completion
Changes in the buccolingual inclinations of maxillary teeth were assessed by comparing pretreatment and posttreatment three-dimensional digital dental models. Measurements were recorded in degrees (°).
1 secondary outcome
Predictability of Digitally Planned Maxillary Expansion
Time frame: Baseline and immediately after treatment completion
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 4 Nov 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.
Yasemin B Acar, Associate Professor principal investigator
Department of Orthodontics, Faculty of Dentistry, Marmara University
Elif A Öztürk, DDS, PhD study director
Marmara University, Institute of Health Sciences, Department of Orthodontics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Custom-Designed Palatal-Coverage Thermoplastic Aligner in people with Cleft Lip and Palate, run by Marmara 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 6 inclusion and 6 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 4 Nov 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?
Change in Maxillary Intercanine Width (time frame: Baseline and immediately after treatment completion). The study lists 8 primary outcomes in all. 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 4 Nov 2026.