Alt-RAMEC Expansion and Protraction by EDO in Cleft Lip and Palate Patient

Cleft Lip and Palate Clinical Trial

Official title:

Evaluation of Alt-RAMEC by EDO With Facemask in Patients With Cleft Lip and Palate (UCLP) Using Cone Beam Computed Tomography (CBCT)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04970095
• Other study ID #: ORTHO-109-2-F
• Status: Recruiting
• Phase: N/A
• Start date: July 15, 2021
• Est. completion date: July 2023

Study information

• Verified date: July 2021
• Source: Faculty of Dental Medicine for Girls
• Contact: sarah s. kahlil, master
• Phone: +201128899261
• Email: sarahabdelaal.p5821[@]azhar.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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). .

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:

• 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

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. consist of forehead cap chin cap 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)

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. — View 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. 2021 Mar 23:10556656211000968. doi: 10.1177/10556656211000968. [Epub ahead of print] — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	change in 3D dimension of skull after and before expansion	Full skull Cone Beam Computerized Tomography	six month

External Links

•   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
•   Maxillary Expander with Differential Opening (EDO)