Clinical trial NCT04970095: Alt-RAMEC Expansion and Protraction by EDO in Cleft Lip and Palate Patient
Official title: Evaluation of Alt-RAMEC by EDO With Facemask in Patients With Cleft Lip and Palate (UCLP) Using Cone Beam Computed Tomography (CBCT)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cleft Lip and Palate
Keywords: Alt-RAMEC
expansion
cleft lip and palate patient
cone beam computed tomography (CBCT)
protraction
facemask
MAXILLARY EXPANDER WITH DIFFERENTIAL OPENING (EDO)
Lead sponsor: Faculty of Dental Medicine for Girls
Sponsor class: OTHER_GOV
First posted: 2021-07-21
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 Alternate Rapid Maxillary Expansion and Constriction Alt-RAMEC 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.Clefts patient 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 by Maxillary Expander with Differential Opening (EDO) with alternate rapid maxillary expansion and constriction (Alt-RAMEC) , which is opened by opening the expansion device by 1 mm per day for a week, then closing the device at a rate of 1 mm per day in the second week and so on alternately for 7 consecutive weeks after the completion of the expansion, the facemask device will be used to protraction of maxilla the measurement and difference before and after treatment will be assessment by cone beam computed tomography (CBCT). .

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Patients had received any surgical assisted expansion or maxillary protraction or fixed orthodontics before.

  2. Maxillary dentition unsuitable to bond the expander (less than two dental unit bedside first permanent molar) .

  3. Absent maxillary permanent first molars. 4. Uncooperative patients/parents

Primary outcomes:
measure: change in 3D dimension of skull after and before expansion
timeFrame: six month
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: maha m. mohamed, phd
role: STUDY_DIRECTOR
References:
citation: Garib D, Lauris RC, Calil LR, Alves AC, Janson G, De Almeida AM, Cevidanes LH, Lauris JR. Dentoskeletal outcomes of a rapid maxillary expander with differential opening in patients with bilateral cleft lip and palate: A prospective clinical trial. Am J Orthod Dentofacial Orthop. 2016 Oct;150(4):564-574. doi: 10.1016/j.ajodo.2016.05.006.
citation: Singh S, Batra P, Raghavan S, Sharma K, Srivastava A. Evaluation of Alt-RAMEC With Facemask in Patients With Unilateral Cleft lip and Palate (UCLP) Using Cone Beam Computed Tomography (CBCT) and Finite Element Modeling-A Clinical Prospective Study. Cleft Palate Craniofac J. 2022 Feb;59(2):166-176. doi: 10.1177/10556656211000968. Epub 2021 Mar 23.