Back to resultsA Clinical Trial to Evaluate the Safety and Effectiveness of MatrixOssTM Bone Graft
Primary Purpose
Dental Diseases
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
MatrixOssTM Bone Graft plus Bio-Gide membrane
Sponsored by
About this trial
This is an interventional treatment trial for Dental Diseases
Eligibility Criteria
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;
- 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;
- Subjects with serious blood system diseases, such as leukemia or other hemorrhagic diseases;
- Subjects with abnormal coagulation function;
- Subjects with severe cardiovascular and cerebrovascular diseases;
- 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.
- Subjects with mental disorder and lack of behavioral autonomy;
- Known allergy or hypersensitivity to animal-derived implantable materials;
- Subjects who refuse to use porcine-derived implantable materials;
- Pregnant and lactating women, or those who plan to conceive within 6 months;
- 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;
- Subjects who smoking more than 5 cigarettes per day;
- Subjects who are alcoholism, drug abuse, or drug dependence;
- 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;
- Other circumstances which are considered by the investigator not suitable for enrollment in this study.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental group
Control group
Arm Description
Those in the experimental group will receive MatrixOssTM Bone Graft plus Bio-Gide membrane.
Those in the control group will receive Bio-Oss Bone Graft plus Bio-Gide membrane
Outcomes
Primary Outcome Measures
Changes in alveolar ridge height from baseline to 24 weeks postoperative.
The alveolar ridge height immediately postoperative and 24 weeks postoperative were measured by CBCT, and changes in alveolar ridge height were calculated. Evaluate whether the changes in alveolar ridge height 24 weeks postoperative in the experimental group was non-inferior to that in the control group.
Secondary Outcome Measures
Changes in alveolar ridge width from baseline to 24 weeks postoperative
The alveolar ridge height immediately postoperative and 24 weeks postoperative were measured by CBCT, and changes in alveolar ridge height were calculated. Compare the changes in alveolar ridge width from baseline to 24 weeks postoperative between the experimental group and control group.
Bone graft density in alveolar socket 24 weeks postoperative
According to the CBCT results at 24 weeks postoperative, the consistency between the bone graft density in alveolar socket and the surrounding alveolar bone density was evaluated. The evaluation contents include:
Lower than surrounding alveolar bone density;
Same as surrounding alveolar bone density;
Higher than surrounding alveolar bone density.
Wound healing
The wound healing conditions of the subjects in the experimental group and control group 10 days postoperative and 4 weeks postoperative were assessed using the Wound Healing Assessment Scale, and the gingival tissue in the implanted area of the material was evaluated as follows:
Score 1 = uneventful healing with no gingival edema, erythema, suppuration, patient discomfort, or flap dehiscence; Score 2 = uneventful healing with slight gingival edema, erythema, patient discomfort, or flap dehiscence but no suppuration; Score 3 = poor wound healing with significant gingival edema, erythema, patient discomfort, flap dehiscence, or any suppuration.
Rejection reaction
Observe whether there are redness, suppuration, inflammation, granulation tissue hyperplasia, exposure/overflow of bone graft and other rejection reactions at the operation site of the subjects in the experimental group and the control group from immediately to 12 weeks postoperative.
Device performance evaluation
The device performance of the experimental device/control device was evaluated by the investigator, and the evaluation criteria were as follows:
Is the product operation convenient?
Convenient
Common
Inconvenient
（2）Is the product easy to fuse with blood?
Easy to fuse
Common
Not easy to fuse
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05371535
Brief Title
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
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 30, 2022 (Anticipated)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Collagen Matrix
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Participant
Allocation
Randomized
Enrollment
188 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Experimental group
Arm Type
Experimental
Arm Description
Those in the experimental group will receive MatrixOssTM Bone Graft plus Bio-Gide membrane.
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Those in the control group will receive Bio-Oss Bone Graft plus Bio-Gide membrane
Intervention Type
Device
Intervention Name(s)
MatrixOssTM Bone Graft plus Bio-Gide membrane
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in alveolar ridge height from baseline to 24 weeks postoperative.
Description
The alveolar ridge height immediately postoperative and 24 weeks postoperative were measured by CBCT, and changes in alveolar ridge height were calculated. Evaluate whether the changes in alveolar ridge height 24 weeks postoperative in the experimental group was non-inferior to that in the control group.
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
Changes in alveolar ridge width from baseline to 24 weeks postoperative
Description
The alveolar ridge height immediately postoperative and 24 weeks postoperative were measured by CBCT, and changes in alveolar ridge height were calculated. Compare the changes in alveolar ridge width from baseline to 24 weeks postoperative between the experimental group and control group.
Time Frame
24 weeks
Title
Bone graft density in alveolar socket 24 weeks postoperative
Description
According to the CBCT results at 24 weeks postoperative, the consistency between the bone graft density in alveolar socket and the surrounding alveolar bone density was evaluated. The evaluation contents include:
Lower than surrounding alveolar bone density;
Same as surrounding alveolar bone density;
Higher than surrounding alveolar bone density.
Time Frame
24 weeks
Title
Wound healing
Description
The wound healing conditions of the subjects in the experimental group and control group 10 days postoperative and 4 weeks postoperative were assessed using the Wound Healing Assessment Scale, and the gingival tissue in the implanted area of the material was evaluated as follows:
Score 1 = uneventful healing with no gingival edema, erythema, suppuration, patient discomfort, or flap dehiscence; Score 2 = uneventful healing with slight gingival edema, erythema, patient discomfort, or flap dehiscence but no suppuration; Score 3 = poor wound healing with significant gingival edema, erythema, patient discomfort, flap dehiscence, or any suppuration.
Time Frame
10 days postoperative and 4 weeks postoperative
Title
Rejection reaction
Description
Observe whether there are redness, suppuration, inflammation, granulation tissue hyperplasia, exposure/overflow of bone graft and other rejection reactions at the operation site of the subjects in the experimental group and the control group from immediately to 12 weeks postoperative.
Time Frame
12 weeks
Title
Device performance evaluation
Description
The device performance of the experimental device/control device was evaluated by the investigator, and the evaluation criteria were as follows:
Is the product operation convenient?
Convenient
Common
Inconvenient
（2）Is the product easy to fuse with blood?
Easy to fuse
Common
Not easy to fuse
Time Frame
24weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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;
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;
Subjects with serious blood system diseases, such as leukemia or other hemorrhagic diseases;
Subjects with abnormal coagulation function;
Subjects with severe cardiovascular and cerebrovascular diseases;
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.
Subjects with mental disorder and lack of behavioral autonomy;
Known allergy or hypersensitivity to animal-derived implantable materials;
Subjects who refuse to use porcine-derived implantable materials;
Pregnant and lactating women, or those who plan to conceive within 6 months;
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;
Subjects who smoking more than 5 cigarettes per day;
Subjects who are alcoholism, drug abuse, or drug dependence;
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;
Other circumstances which are considered by the investigator not suitable for enrollment in this study.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Meenakshi Paliwal
Phone
201-405-1477
Ext
324
Email
mpaliwal@collagenmatrix.com
First Name & Middle Initial & Last Name or Official Title & Degree
Peggy Hansen
Email
phansen@collagenmatrix.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Jian Pan
Organizational Affiliation
West China Stomatological Hospital of Sichuan University
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Clinical Trial to Evaluate the Safety and Effectiveness of MatrixOssTM Bone Graft
We'll reach out to this number within 24 hrs