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

Not Applicable

• Conditions: Cleft Lip and Palate
• Interventions: Device: Maxillary Expander with Differential Opening (EDO); Device: Petit Face Mask

• Registration Number: NCT04970095
• Lead Sponsor: Faculty of Dental Medicine for Girls

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). .

Study Timeline

• Status Verified: 2021-07
• Study Start: 2021-07-15
• Study First Submitted: 2021-07-16
• Study First Submitted QC: 2021-07-16
• Last Update Submitted: 2021-07-20
• Study First Posted: 2021-07-21
• Last Update Posted: 2021-07-27
• Primary Completion: 2022-07
• Study Completion: 2023-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
cleft lip and palate patient	Maxillary Expander with Differential Opening (EDO)	Clefts patient with transverse maxillary constriction and anteroposterior deficiency
cleft lip and palate patient	Petit Face Mask	Clefts patient with transverse maxillary constriction and anteroposterior deficiency

Primary Outcome Measures

Name	Time	Method
change in 3D dimension of skull after and before expansion	six month	Full skull Cone Beam Computerized Tomography

Trial Locations

Locations (1)

faculty of dental medicine for Girls, Al- Azhar University; 🇪🇬 Cairo, Nasr City, Egypt