UnknownNot Applicable

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 range18 Years – 65 Years

SexALL

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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;

What they're measuring

Changes in alveolar ridge height from baseline to 24 weeks postoperative.

Timeframe: 24 weeks

Trial details

NCT IDNCT05371535

SponsorCollagen Matrix

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2022-11-30

Contact for this trial

Meenakshi Paliwal

201-405-1477 mpaliwal@collagenmatrix.com

View on ClinicalTrials.gov More Dental Diseases trials