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

NCT06994754 | Recruiting DMC

• 1 other identifier: ORTH 3-3-7
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Maxillary Deficiency; Cleft Lip and Palate

Keywords

Maxillary Expansion by Aligners

Outcome Measures

Primary Outcomes (1)

• 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.

  six months

Study Arms (1)

Bilateral cleft lip and palate patients

EXPERIMENTAL

Device: clear aligners

Interventions

clear aligners DEVICE

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

Bilateral cleft lip and palate patients

Eligibility Criteria

• Age: 6 Years - 12 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Syndromic cleft lip and palate patients.
• Taking medications that influence growth.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Dentistry - Cairo University

Cairo, Select, 11511, Egypt

RECRUITING

MeSH Terms

Conditions

Retrognathia; Cleft Lip

Condition Hierarchy (Ancestors)

Jaw Abnormalities; Jaw Diseases; Musculoskeletal Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Stomatognathic Diseases; Mandibular Diseases; Stomatognathic System Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Lip Diseases; Mouth Diseases; Mouth Abnormalities

Central Study Contacts

mahmoud Abo-Salem, M.SC

CONTACT

+201112052622; mahmoud.abdelsalam@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master degree candidate at Orthodontic Department

Study Record Dates

• First Submitted: March 29, 2025
• First Posted: May 29, 2025
• Study Start: April 6, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 12, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will share

Locations

EG (1)