A Clinical Trial to Evaluate the Safety and Effectiveness of MatrixOssTM Bone Graft (NCT05371535) | Clinical Trial Compass
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A Clinical Trial to Evaluate the Safety and Effectiveness of MatrixOssTM Bone Graft
188 participantsStarted 2022-05-30
Plain-language summary
The objective of this clinical trial is to evaluate the efficacy and safety of MatrixOssTM Bone Graft in bone defect repair caused by tooth extraction.
Who can participate
Age range
18 Years – 65 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
. Male or female patients aged 18-65 years (including 18 years and 65 years);
. Bone loss caused by singe tooth extraction requiring bone grafting;
. At least one natural tooth adjacent to the targeted tooth;
. The subjects could understand the purpose of this trial, voluntarily participate in this trial and willing to sign an Informed Consent Form (ICF).
Exclusion criteria
. Bone defect caused by invasive or malignant bone tumors；
. Subjects with uncontrolled periodontitis, acute periapical inflammation;
. Subjects who are receiving or had received any drug in last 3 months that may influence or promote bone metabolism;
. Active infectious disease, various bone defects during the active phase of metabolic bone disease;
. Subjects with acute or chronic infection (osteomyelitis) at the surgical site;
. Subjects with osteoporosis or osteomalacia;
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
Changes in alveolar ridge height from baseline to 24 weeks postoperative.
. Alanine Aminotransferase，ALT）Aspartate Aminotransferase，AST） Subjects with abnormal liver or kidney functions (ALT or AST or creatinine exceeds 1.5 times the upper limit of normal range);
. Subjects who has a history of or is undergoing cervico-facial radiotherapy or chemotherapy;