Slow Expansion and Protraction in Cleft Lip and Palate Patients

Cleft Lip and Palate Clinical Trial

Official title:

Evaluation of the Treatment Outcome of Cleft Palate Patients Treated With Differential Opening Expander With Slow Protocol and Face Mask

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04997083
• Other study ID #: ORTHO-109-2-D
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2021
• Est. completion date: July 2023

Study information

• Verified date: August 2021
• Source: Faculty of Dental Medicine for Girls
• Contact: Amira H. Eldawy, Master
• Phone: +201112788674
• Email: amiraeldawy.p5821[@]azhar.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Evaluate the treatment outcome of slow maxillary expansion protocol on patients with cleft lip and palate, using a differential opening expander and face mask which will be measured and recorded by cone beam computed tomography (CBCT).

Description:

Cleft lip and palate are among the most common deformities in children. Cleft patients are usually having orofacial problems as missing or unerupted permanent teeth, alveolar bone defect, speech difficulty. Patients with cleft lip and palate (CLP) commonly have maxillary arch constriction (maxillary hypoplasia) and Class III malocclusions due to deficient of maxillary growth. The upper jaw of patients with cleft palate will be expanded using maxillary Expander with Differential Opening (EDO) which has two screws; one anterior and one posterior. This will be done with slow expansion protocol, which is one 1/4 turn three times weekly. Petit facemask will be used to protract the retracted maxilla. The differences in measurements between before and after treatment will be assessed by cone beam computed tomography (CBCT).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: July 2023
• Est. primary completion date: July 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 8 Years to 12 Years

Eligibility

Inclusion Criteria:

• All patient age ranges from 8 to 12 years.
• Patients of both sexes.
• Cleft lip and palate patients.
• All the cases showed maxillary arch constriction and deficiency.
• All patients had maxillary permanent first molars.
• Primary lip adhesion and palatal closure.

Exclusion Criteria:

• Patients had received any surgical assisted rapid maxillary expansion or maxillary protraction of fixed orthodontics before.
• Maxillary dentition unsuitable to bond the expander (less than two dental units beside permanent first molar).
• Absent maxillary permanent first molars.
• Uncooperative patients/parents.

Related Conditions & MeSH terms

• Cleft Lip
• Cleft Lip and Palate

Intervention

Device:
• Maxillary Expander with Differential Opening (EDO)
The EDO is designed with two expansion screws positioned transversely. When more expansion is required between the canines, the anterior screw can be further activated. Both expansion screws can be activated to open in a parallel configuration. Pivoting corner screws allow for different amounts of expansion without significant risk of binding during activation.
• Petit face mask
The face mask is anatomical, multi-adjustable, lightweight and an ideal therapeutic alternative for the correction of Class III malocclusion. It consists of forehead cap, chin cap, and cross bar.

Locations

Country	Name	City	State
Egypt	Faculty of dental medicine for girls, Al-Azhar University	Cairo	Nasr City

Sponsors (1)

Lead Sponsor	Collaborator
Faculty of Dental Medicine for Girls

Country where clinical trial is conducted

Egypt, 

References & Publications (2)

Alves ACM, Janson G, Mcnamara JA Jr, Lauris JRP, Garib DG. Maxillary expander with differential opening vs Hyrax expander: A randomized clinical trial. Am J Orthod Dentofacial Orthop. 2020 Jan;157(1):7-18. doi: 10.1016/j.ajodo.2019.07.010. — View Citation

Massaro C, Garib D, Cevidanes L, Janson G, Yatabe M, Lauris JRP, Ruellas AC. Maxillary dentoskeletal outcomes of the expander with differential opening and the fan-type expander: a randomized controlled trial. Clin Oral Investig. 2021 Feb 12. doi: 10.1007/s00784-021-03832-9. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in 3 dimensions of skull before and after expansion	Full skull Cone Beam Computerized Tomography	Six months

External Links

•   Maxillary dentoskeletal outcomes of the expander with differential opening and the fan-type expander: a randomized controlled trial
•   Maxillary expander with differential opening vs Hyrax expander: A randomized clinical trial