Cleft Lip and Palate Clinical Trial
Official title:
Evaluation of the Treatment Outcome of Cleft Palate Patients Treated With Differential Opening Expander With Slow Protocol and Face Mask
NCT number | NCT04997083 |
Other study ID # | ORTHO-109-2-D |
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 slow maxillary expansion 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: - All patient age ranges from 8 to 12 years. - Patients of both sexes. - Cleft lip and palate patients. - All the cases showed maxillary arch constriction and deficiency. - All patients had maxillary permanent first molars. - Primary lip adhesion and palatal closure. Exclusion Criteria: - Patients had received any surgical assisted rapid maxillary expansion or maxillary protraction of fixed orthodontics before. - Maxillary dentition unsuitable to bond the expander (less than two dental units beside permanent first molar). - Absent maxillary permanent first molars. - 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,
Alves ACM, Janson G, Mcnamara JA Jr, Lauris JRP, Garib DG. Maxillary expander with differential opening vs Hyrax expander: A randomized clinical trial. Am J Orthod Dentofacial Orthop. 2020 Jan;157(1):7-18. doi: 10.1016/j.ajodo.2019.07.010. — View Citation
Massaro C, Garib D, Cevidanes L, Janson G, Yatabe M, Lauris JRP, Ruellas AC. Maxillary dentoskeletal outcomes of the expander with differential opening and the fan-type expander: a randomized controlled trial. Clin Oral Investig. 2021 Feb 12. doi: 10.1007/s00784-021-03832-9. [Epub ahead of print] — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Changes in 3 dimensions of skull before and after expansion | Full skull Cone Beam Computerized Tomography | Six months |
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