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 @ 2:08 AM
Ignite Modification Date:
2025-12-25 @ 2:08 AM
NCT ID:
NCT06536660
Eligibility Criteria:
Inclusion Criteria:
1. Participants must be 18 years of age or older.
2. Participants must have confirmed indications for jaw surgery with internal fixation, such as alveolar onlay bone grafting, fracture fixation, orthognathic surgery, or reconstructive surgery.
3. Participants should have adequate bone quality and sufficient bone volume to support the placement of magnesium bone plates and screws.
4. Participants must provide written informed consent, indicating their understanding of the potential risks and benefits of magnesium bone plate and screw fixation.
Exclusion Criteria:
1. Participants with certain medical conditions that may affect bone healing or increase the risk of complications, such as uncontrolled diabetes, severe osteoporosis, multiple myelomas, or active bone infections.
2. Participants with medical conditions that may exacerbate or predispose them to systemic side effects of magnesium implants, thus contraindicating their use, should be excluded. These conditions include chronic kidney disease, hypermagnesemia, severe electrolyte imbalances, severe heart disease (especially in those with a history of arrhythmias or heart failure), myasthenia gravis, abnormal thyroid functions, hyperparathyroidism, and adrenocortical insufficiency.
3. Participants with known allergies or hypersensitivity to magnesium.
4. Participants with an ASA score of 3 or above, indicating a higher risk for general anesthesia.
5. Participants who are pregnant or breastfeeding.
6. Participants deemed unlikely to comply with the study protocol, such as attending follow-up appointments or adhering to post-operative care instructions.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06536660
Study Brief:
Protocol Section:
NCT06536660