Dental DiseasesNCT05371535
A Clinical Trial to Evaluate the Safety and Effectiveness of MatrixOssTM Bone Graft
A study testing MatrixOssTM Bone Graft plus Bio-Gide membrane in people with Dental Diseases, run by Collagen Matrix.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Diseases
- What is being tested?
- MatrixOssTM Bone Graft plus Bio-Gide membrane
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- No sites listed yet
- Study dates
- 30 May 2022to 30 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
No sites are listed yet.
Peggy Hansen contact
About this study
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
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.
Read the 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.
- Conditions
- Dental Diseases
- Being tested
- MatrixOssTM Bone Graft plus Bio-Gide membrane
- Medical subject headings
- Stomatognathic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MatrixOssTM Bone Graft plus Bio-Gide membraneDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Those in the experimental group will receive MatrixOssTM Bone Graft plus Bio-Gide membrane. Receives: Device: MatrixOssTM Bone Graft plus Bio-Gide membrane |
| Control group | Active comparator | Those in the control group will receive Bio-Oss Bone Graft plus Bio-Gide membrane Receives: Device: MatrixOssTM Bone Graft plus Bio-Gide membrane |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks
Secondary outcomes (5)
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.
Measured: 24 weeks
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.
Measured: 24 weeks
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.
Measured: 10 days postoperative and 4 weeks postoperative
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.
Measured: 12 weeks
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
Measured: 24weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2022
- Study start30 May 2022 (estimated)
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Collagen Matrix
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dr. Jian Pan, Principal investigator, West China Stomatological Hospital of Sichuan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05371535
- Sponsor's protocol ID
- WCHSIRB-D-2022-154
- Status last verified
- May 2022
- First submitted
- 9 May 2022
- Last updated
- 12 May 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05371535
- Acronym / sponsor ID
- WCHSIRB-D-2022-154
- Conditions
- Dental Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Collagen MatrixIndustry (pharma, biotech, devices)
- Study start
- 30 May 2022 (estimated)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 12 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Device: MatrixOssTM Bone Graft plus Bio-Gide membraneThose in the experimental group will receive MatrixOssTM Bone Graft plus Bio-Gide membrane. |
| Control group | Active comparator | Device: MatrixOssTM Bone Graft plus Bio-Gide membraneThose in the control group will receive Bio-Oss Bone Graft plus Bio-Gide membrane |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (21 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MatrixOssTM Bone Graft plus Bio-Gide membraneTo verify the efficacy and safety of MatrixOssTM Bone Graft developed and manufactured by Collagen Matrix, Inc. for bone defect repair caused by tooth extraction. | Device | Control group, Experimental group |
Primary outcome
Changes in alveolar ridge height from baseline to 24 weeks postoperative.
Time frame: 24 weeks
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.
5 secondary outcomes
Changes in alveolar ridge width from baseline to 24 weeks postoperative
Time frame: 24 weeks
Bone graft density in alveolar socket 24 weeks postoperative
Time frame: 24 weeks
Wound healing
Time frame: 10 days postoperative and 4 weeks postoperative
Rejection reaction
Time frame: 12 weeks
Device performance evaluation
Time frame: 24weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peggy Hansen contact
Dr. Jian Pan principal investigator
West China Stomatological Hospital of Sichuan University
Questions about this trial
What is this clinical trial studying?
A study testing MatrixOssTM Bone Graft plus Bio-Gide membrane in people with Dental Diseases, run by Collagen Matrix.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 May 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Meenakshi Paliwal (201-405-1477 ext. 324, mpaliwal@collagenmatrix.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in alveolar ridge height from baseline to 24 weeks postoperative. (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2022.