Assessment of Bone Volume Using Patient Specific Autogenous Bone Plug Versus Particulate Autogeno… (NCT07137975) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Assessment of Bone Volume Using Patient Specific Autogenous Bone Plug Versus Particulate Autogenous Bone for Unilateral Alveolar Ridge Reconstruction
Egypt16 participantsStarted 2025-08-30
Plain-language summary
Most common complications that arise from alveolar cleft repair surgeries are; failure of graft integration, wound dehiscence, scar tissue formation, infections, bone exposure and oral-nasal fistula formation.
Alveolar cleft patients have compromised soft tissue which increase the chance of graft exposure.
To Augment the alveolar defect in three-dimensions, accurate assessment of alveolar cleft is essential, virtual surgical planning can be combined with 3D printing to re-create the defect virtually. Based of virtually created defect a patient specific mold can be designed. Printed mold will be used as a medium for adding particulate autogenous graft mixed with fibrin glue creating a plug with the precise shape of the alveolar cleft, the fibrin glue will assist in forming the plug as well as acting as a scaffold for migrating fibroblasts as well as a hemostatic barrier, stimulates mesenchymal cell, induces and promotes angiogenesis, and also initiates early osteogenesis.
Who can participate
Age range
7 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.
1. Inclusion criteria:
* Patients with unilateral alveolar clefts who completed pre-operative expansion.
* Patients with good oral hygiene.
* Patients free from any medical condition that might compromise the healing process.
* Both males and females will be included in trail.
* Age range from 7 years to 12 years.
2. Exclusion criteria:
* Unmotivated/uncooperative patients and/or parents.
* Patients who previously underwent unsuccessful treatment trails.
* Patients with insufficient ridge expansion.
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.