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)
NCT number | NCT04970095 |
Other study ID # | ORTHO-109-2-F |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 15, 2021 |
Est. completion date | July 2023 |
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).
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 |
Country | Name | City | State |
---|---|---|---|
Egypt | faculty of dental medicine for Girls, Al- Azhar University | Cairo | Nasr City |
Lead Sponsor | Collaborator |
---|---|
Faculty of Dental Medicine for Girls |
Egypt,
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
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 |
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