An interventional study of clear aligners in Maxillary Deficiency and Cleft Lip and Palate, sponsored by Cairo University. Recruiting at 1 site in Egypt. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-06-12.
Sponsored by Cairo University · Not applicable, Interventional, and Treatment
The goal of this clinical trial is to learn if the aligners can expand upper dental arch in patients with cleft lip and palate at age of 6-8 years old to correct their collapsid archs. The main questions it aims to answer are:
Does aligners can achieve transverse dento-skeletal changes? Does aligners can achieve anteroposterior and vertical dento-skeletal changes?
Participants will:
Wear sequence of aligners (each for 10 days). Visit the clinic every month for checkups. 3D x-ray and intraoral scan will be taken after completion of the aligners set to evaluate the intervention.
Cleft lip and palate (CLP) is the most prevalent among all craniofacial anomalies, affecting one in every 700 births and disturbing the quality of life of more than 7 million people around the world.
Cleft lip and palate are defined as malformations characterized by the non-union of the upper lip and/or palate, either separately or in conjunction with another syndrome. Its etiology is rather complex and definitely multifactorial, where complex interplay between genetic and environmental factors play a significant role in the incidence and cause of cleft.
Cleft lips can be unilateral or bilateral, and may involve the alveolus or palate. Unilateral cleft lip shows a 2:1 left predominance.
Lip and palate surgical repairs are performed in the first months and years of life respectively. As a consequence, the growth and development of the maxillary segments are compromised by scar tissues, presenting a significant maxillary transverse deficiency with medially collapsed cleft segments accompanied with anterior crossbite or both anterior and posterior crossbites. Most CLP patients present a narrower anterior than posterior maxillary arch frequently showing a crossbite in both canine and premolar areas and a normal occlusal transverse molar relationship.
Maxillary expansion is usually performed before the secondary alveolar bone grafting procedure. Expansion improves the maxillary arch morphology and causes the segmental alignment creating appropriate conditions for bone grafting surgery as well as correcting the posterior crossbites.
Variable appliances have been used for maxillary arch expansion in cleft patients for example Quad-helix, Hyrax and Haas expanders with its modifications with or without teeth alignment.
The investigators will conducted this clinical trial to evaluate if clear aligners (the new substitute to the conventional metal orthodontics) can achieve true dentoskeletal expansion in the three dimensions.
After clinical examination, intraoral scan taken also intra-oral and extra-oral photos. Requesting full skull CBCT.
Segmentation of teeth and palate using 3-shape software. Using aligner module to plan around 8-12 aligners with maximum velocity of 0.3 mm translation and 3 degree of rotation.
Exporting the models and fabrication of aligners using 1 mm thickness sheets. Delivery of aligners to the patient. Follow up every month. Full face CBCT and intraoral scan will be taken after completion of the intervention.
Measuring and superimpose the data before and after to extract the results.
62 studies on the registry are indexed under Retrognathia; 15 are open to participants now.
This study's planned enrollment of 10 is below the median of 34 across 52 interventional studies indexed under Retrognathia.
Browse Retrognathia studies →Cairo University is the lead sponsor of 4,941 studies on the registry; 1,458 are open to participants now.
Of its 37 completed or terminated interventional studies of FDA-regulated products, 5 (14%) have results posted.
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Exclusion Criteria:
Device: clear aligners
aligners made with 1mm thickness sheet and covering the whole palate
Transverse dento-skeletal changes
Using pre and post treatment cone beam computed tomography (CBCT), 3D point identification and landmark development will be done. On the CBCT, skeletal transvers maxillary width, anterior, middle and posterior cleft width, intermolar, inter premolar and inter-canine widths will be measured.
Time frame: six months
Plan to share: Yes — All IPD collected throughout the trial
No publications or documents are linked to this record.
Started Apr 2025 (actual). Primary completion is estimated for Oct 2026, 18 months after the start.
Of 30 interventional studies with no phase under Retrognathia, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 14 and three quarters within 35. This study's planned 18 months is close to that.
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