Actively Recruiting
Evaluation of Maxillary Expansion Using Clear Aligners' Therapy in Patients With Cleft Lip and Palate at the Mixed Dentition Stage: A Pilot Study
Led by Cairo University · Updated on 2025-06-12
10
Participants Needed
1
Research Sites
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating if clear aligners can expand the upper dental arch in children aged 6 to 8 years old with cleft lip and palate who have collapsed arches. This study aims to determine whether these aligners can cause changes in the width, front-to-back, and vertical dimensions of the dento-skeletal structure. The trial is a pilot study focused on patients with bilateral cleft lip and palate in the mixed dentition stage. Participants will use a series of clear aligners made from 1mm thick sheets that cover the entire palate. Each aligner is worn for 10 days, and patients will visit the clinic monthly for checkups. Around 8 to 12 aligners are planned per patient based on detailed scans and 3D planning software. After completing the aligner treatment, 3D x-rays and intraoral scans will be taken to assess the changes achieved. Throughout the study, participants will have clinical examinations, intraoral and extraoral photos, and full skull CBCT scans before and after treatment. Teeth and palate data will be segmented and analyzed using specialized software to measure the dento-skeletal changes. The main outcome is the transverse dento-skeletal changes evaluated over six months, with follow-up visits every month and detailed monitoring of progress and results.
CONDITIONS
Brief Title
Evaluation of Maxillary Expansion Using Clear Aligners' Therapy in Patients With Cleft Lip and Palate at the Mixed Dentition Stage
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Mixed dentition.
- Both males and females.
- Bilateral cleft lip and palate.
- Lip repair performed between 3 and 6 months of age.
- Palate repair performed between 12 and 24 months of age.
- Presence of maxillary constriction needing expansion.
- Good periodontal health.
- No previous orthodontic treatment.
You will not qualify if you...
- Syndromic cleft lip and palate patients.
- Taking medications that influence growth.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Approximately 6 months
Participants receive maxillary expansion therapy using clear aligners made with 1mm thickness sheets covering the whole palate.
Monthly visits for aligner delivery and follow-up
Trial Site Locations
Total: 1 location
1
Faculty of Dentistry - Cairo University
Cairo, Select, Egypt, 11511
Actively Recruiting
Research Team
M
mahmoud Abo-Salem, M.SC
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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