Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2025-12-25 @ 3:30 AM
NCT ID:
NCT05283005
Eligibility Criteria:
Inclusion Criteria:
* Patients with complete maxillary alveolar cleft either unilateral or bilateral at the age of mixed dentition (between 7 and 13 years old).
* repaired cleft lip.
* Patients with cleft lip and palate who have not undergone alveolar grafting procedure.
* Patients with unerupted maxillary permanent canine in the cleft region.
* Patients with medical history that did not hinder surgical intervention and have adequate proper oral hygiene.
* Both genders males and females will be included
Exclusion Criteria:
* General contraindications to surgical intervention of the area. Patients with ill repaired cleft lip that will hinder the appropriate reconstruction of the alveolar cleft.
* Patients with associated syndrome.
* Patients requiring concomitant Orthognathic surgical procedure.
* Subjected to irradiation in the head and neck area less than 1 year before surgery.
* Untreated periodontitis.
* Poor oral hygiene.
* Uncontrolled diabetes.
* Immunosuppressed or immunocompromised.
* Treated or under treatment with intravenous amino-bisphosphonates.
* Active infection or severe inflammation in the area intended for graft placement.
* Patients participating in other studies, if the present protocol could not be properly followed.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
6 Years
Maximum Age:
14 Years
Study:
NCT05283005
Study Brief:
Protocol Section:
NCT05283005