Clinical trial NCT05371535: A Clinical Trial to Evaluate the Safety and Effectiveness of MatrixOssTM Bone Graft
Official title: A Prospective, Randomized, Multi-center, Parallel Controlled Trial Evaluating the Efficacy and Safety of MatrixOssTM Bone Graft in Bone Defect Repair Caused by Tooth Extraction
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Diseases
Lead sponsor: Collagen Matrix
Sponsor class: INDUSTRY
First posted: 2022-05-12
Enrollment: 188
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects included will be randomly assigned into the experimental group and the control group at a ratio of 1:1. Those in the experimental group will receive MatrixOssTM Bone Graft plus Bio-Gide membrane, and those in the control group will receive Bio-Oss Bone Graft plus Bio-Gide membrane.
Primary purpose: TREATMENT

Brief 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.

Detailed description: This is a prospective, randomized, multi-center and parallel controlled clinical trial. It is planned to be carried out in more than 3 (including 3) hospitals with qualifications as a national-level clinical trial institution. Subjects included will be randomly assigned into the experimental group and the control group at a ratio of 1:1. Those in the experimental group will receive MatrixOssTM Bone Graft plus Bio-Gide membrane, and those in the control group will receive Bio-Oss Bone Graft plus Bio-Gide membrane. To evaluate whether the changes in alveolar ridge height from baseline to 24 weeks postoperative in the experimental group is non-inferior to that in the control group, so as to verify the efficacy and safety of MatrixOssTM Bone Graft developed and manufactured by Collagen Matrix, Inc. for bone defect repair caused by tooth extraction.

Eligibility criteria: Inclusion Criteria:

1. Male or female patients aged 18-65 years (including 18 years and 65 years);
2. Bone loss caused by singe tooth extraction requiring bone grafting;
3. At least one natural tooth adjacent to the targeted tooth;
4. 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:

1. Bone defect caused by invasive or malignant bone tumors；
2. Subjects with uncontrolled periodontitis, acute periapical inflammation;
3. Subjects who are receiving or had received any drug in last 3 months that may influence or promote bone metabolism;
4. Active infectious disease, various bone defects during the active phase of metabolic bone disease;
5. Subjects with acute or chronic infection (osteomyelitis) at the surgical site;
6. Subjects with osteoporosis or osteomalacia;
7. 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);
8. Subjects who has a history of or is undergoing cervico-facial radiotherapy or chemotherapy;
9. Subjects with serious blood system diseases, such as leukemia or other hemorrhagic diseases;
10. Subjects with abnormal coagulation function;
11. Subjects with severe cardiovascular and cerebrovascular diseases;
12. Subjects with systemic diseases may affect postoperative healing and/or osseointegration, such as diabetes, uncontrolled hypertension (systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg), hyperparathyroidism, etc.
13. Subjects with mental disorder and lack of behavioral autonomy;
14. Known allergy or hypersensitivity to animal-derived implantable materials;
15. Subjects who refuse to use porcine-derived implantable materials;
16. Pregnant and lactating women, or those who plan to conceive within 6 months;
17. Subjects with implants adjacent to the targeted teeth that can cause oral imaging artifacts, such as metal dentures, porcelain teeth, etc. that may cause oral imaging artifacts;
18. Subjects who smoking more than 5 cigarettes per day;
19. Subjects who are alcoholism, drug abuse, or drug dependence;
20. Subjects who have participated or are participating in a drug clinical trials in last 3 months, or have participated in other medical device clinical trials in last 30 days;
21. Other circumstances which are considered by the investigator not suitable for enrollment in this study.

Primary outcomes:
measure: Changes in alveolar ridge height from baseline to 24 weeks postoperative.
timeFrame: 24 weeks
Secondary outcomes:
measure: Changes in alveolar ridge width from baseline to 24 weeks postoperative
timeFrame: 24 weeks
measure: Bone graft density in alveolar socket 24 weeks postoperative
timeFrame: 24 weeks
measure: Wound healing
timeFrame: 10 days postoperative and 4 weeks postoperative
measure: Rejection reaction
timeFrame: 12 weeks
measure: Device performance evaluation
timeFrame: 24weeks
Other outcomes:
Locations:
Study officials:
affiliation: West China Stomatological Hospital of Sichuan University
name: Dr. Jian Pan
role: PRINCIPAL_INVESTIGATOR
References: