About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Mixed dentition.
Both males and females.
Bilateral cleft lip and palate.
Lip repair performed between 3 and 6 months of age and palate repair performed between 12and 24 months of age.
Disqualifiers
Syndromic cleft lip and palate patients.
Taking medications that influence growth.
Trial design
Single group
Treatments tested in this trial
clear aligners
Devicealigners made with 1mm thickness sheet and covering the whole palate
Treatment groups
Trial outcomes
Primary outcomes
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.
Sponsors and contacts
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