An interventional study of Custom-Designed Palatal-Coverage Thermoplastic Aligner in Cleft Lip and Palate, sponsored by Marmara University. Completed at 1 site in Turkey (Türkiye). Open to participants aged 6 Years to 9 Years. Per ClinicalTrials.gov, last updated 2026-11-04.
Sponsored by Marmara University · Not applicable, Interventional, and Treatment
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.
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.
168 studies on the registry are indexed under Cleft Lip; 51 are open to participants now.
This study's enrollment of 8 is below the median of 30 across 116 interventional studies indexed under Cleft Lip.
Browse Cleft Lip studies →Marmara University is the lead sponsor of 599 studies on the registry; 138 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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.
Exclusion Criteria:
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.
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.
Device: Custom-Designed Palatal-Coverage Thermoplastic Aligner
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.
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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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 (°).
Time frame: Baseline and immediately after treatment completion
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.
Time frame: Baseline and immediately after treatment completion
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2024 to primary completion in Mar 2026, 22 months.
Of 64 non-industry interventional studies with no phase under Cleft Lip, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 33. This study's 22 months is close to that.
Counting every sponsor, half of 65 studies reached it within 22 months; a quarter within 15 and three quarters within 33.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.