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Recruiting Not applicable

Evaluation of Maxillary Expansion Using Clear Aligners' Therapy in Patients With Cleft Lip and Palate at the Mixed Dentition Stage

NCT06994754 · tracked via the Priya Life Science Egypt tracker
Phase
Not applicable
Started
2025-04-06
Last updated
2025-06-12

Condition(s) studied

Maxillary DeficiencyCleft Lip and Palate

Investigational drug(s) / intervention(s)

clear aligners

clear aligners: aligners made with 1mm thickness sheet and covering the whole palate

Study summary

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

Sex
ALL
Min age
6 Years
Max age
12 Years
Healthy volunteers
No
Inclusion Criteria: * 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. * Presence of maxillary constriction that needs maxillary expansion. * Good periodontal health. * No previous orthodontic treatment. Exclusion Criteria: * Syndromic cleft lip and palate patients. * Taking medications that influence growth.

Primary outcome measure(s)

  • Transverse dento-skeletal changes — six months
    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.

Trial sites (1)

FacilityCityRegionStatus
Faculty of Dentistry - Cairo University Cairo Select Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06994754 on ClinicalTrials.gov ↗ ← All trials in Egypt