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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04970095
Enrollment
10
Registered
2021-07-21
Start date
2021-07-15
Completion date
2023-07-31
Last updated
2021-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

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)

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). .

Interventions

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.

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

Sponsors

Faculty of Dental Medicine for Girls
Lead SponsorOTHER_GOV

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
8 Years to 12 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
change in 3D dimension of skull after and before expansionsix monthFull skull Cone Beam Computerized Tomography

Countries

Egypt

Contacts

Primary Contactsarah s. kahlil, master
sarahabdelaal.p5821@azhar.edu.eg+201128899261
Backup Contactmohamed m. elabd, master
sarahlala83@gmail.com+201064244061

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026