NCT05371535

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
188

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started May 2022

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 9, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 12, 2022

Completed
18 days until next milestone

Study Start

First participant enrolled

May 30, 2022

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2023

Completed
Last Updated

May 12, 2022

Status Verified

May 1, 2022

Enrollment Period

6 months

First QC Date

May 9, 2022

Last Update Submit

May 9, 2022

Conditions

Dental Diseases

Outcome Measures

Primary Outcomes (1)

  • 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.

    24 weeks

Secondary Outcomes (5)

  • Changes in alveolar ridge width from baseline to 24 weeks postoperative

    24 weeks

  • Bone graft density in alveolar socket 24 weeks postoperative

    24 weeks

  • Wound healing

    10 days postoperative and 4 weeks postoperative

  • Rejection reaction

    12 weeks

  • Device performance evaluation

    24weeks

Study Arms (2)

Experimental group

EXPERIMENTAL

Those in the experimental group will receive MatrixOssTM Bone Graft plus Bio-Gide membrane.

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

Device: MatrixOssTM Bone Graft plus Bio-Gide membrane

Interventions

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.

Control groupExperimental group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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;
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Stomatognathic Diseases

Study Officials

  • Dr. Jian Pan

    West China Stomatological Hospital of Sichuan University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Meenakshi Paliwal

CONTACT

201-405-1477mpaliwal@collagenmatrix.com

Peggy Hansen

CONTACT

phansen@collagenmatrix.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2022

First Posted

May 12, 2022

Study Start

May 30, 2022

Primary Completion

November 30, 2022

Study Completion

June 30, 2023

Last Updated

May 12, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share