Evaluation of Bilateral Alveolar Cleft Grafting With Micro Plate Stabilization Versus Conventiona… (NCT06523855) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Evaluation of Bilateral Alveolar Cleft Grafting With Micro Plate Stabilization Versus Conventional Grafting Technique
Egypt12 participantsStarted 2024-07-24
Plain-language summary
The aim of the study is to enhance the maxillary segments stability during graft healing using microplate fixation to be compared with conventional grafting technique regarding gained bone quality and quantity.
Who can participate
Age range
9 Years – 12 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with bilateral complete maxillary alveolar cleft at the age of mixed dentition (between 9 and 12 years old).
* repaired cleft lip.
* 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 unilateral maxillary alveolar cleft.
* Patients with ill repaired cleft lip that will hinder the appropriate reconstruction of the alveolar cleft
* 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.
* Active infection or severe inflammation in the area intended for graft placement
* Unable to open mouth sufficiently to accommodate the surgical tooling.
* Patients participating in other studies, if the present protocol could not be properly followed.
* Unable to attend a 9-month follow-up.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Bone density immediate versus 6 months postoperatively.