Clinical trial NCT04997083: Slow Expansion and Protraction in Cleft Lip and Palate Patients
Official title: Evaluation of the Treatment Outcome of Cleft Palate Patients Treated With Differential Opening Expander With Slow Protocol and Face Mask
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cleft Lip and Palate
Keywords: Cleft lip and palate
Expansion
Slow expansion
Maxillary expander with differential opening (EDO)
Protraction
Face mask
Cone beam computed tomography (CBCT)
Lead sponsor: Faculty of Dental Medicine for Girls
Sponsor class: OTHER_GOV
First posted: 2021-08-09
Enrollment: 10
Sex: ALL
Minimum age (years): 8
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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).

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Changes in 3 dimensions of skull before and after expansion
timeFrame: Six months
Secondary outcomes:
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of dental medicine for girls, Al-Azhar University
state: Nasr City
Study officials:
affiliation: Lecturer of Orthodontics Department, Faculty of Dental Medicine for Girls, Al-Azhar University
name: Amany M. Diab, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
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 Sep;25(9):5247-5256. doi: 10.1007/s00784-021-03832-9. Epub 2021 Feb 12.