MinerOss X Plug + Striate+ Membrane for Socket Preservation

Overseen By Chia-Yu Chen, DDS, DMSc

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Harvard School of Dental Medicine

Must not be taking: Blood thinners

Disqualifiers: Periodontal disease, Diabetes, Malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The primary objective of this proposed clinical trial is to provide detailed comparison and evidence of new bone formation in patients undergoing socket preservation utilizing MinerOss® X Plug with and without Striate+ Membrane to maintain ridge dimension after a tooth extraction.

Research Team

David M Kim, DDS, DMSc

Principal Investigator

Harvard School of Dental Medicine

Eligibility Criteria

This trial is for men and women aged 20-70 who want dental implants to replace a single-rooted tooth they need extracted, with healthy neighboring teeth. Participants should be in good health, not on complicating medications, and willing to consent and return for follow-ups.

Inclusion Criteria

I am between 20 and 70 years old and want dental implant treatment.

Subjects who are willing to sign an informed consent, participate and return for follow-up visits.

I am not on any medications that could affect the study.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo socket preservation using MinerOss X Plug with or without Striate+ Membrane

12 months

Regular visits for clinical, radiographic, histologic, and histomorphometric analyses

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• MinerOss® X Plug
• Striate+ Membrane

Trial Overview The study compares new bone growth in patients after tooth extraction using MinerOss® X Plug alone or combined with Striate+ Membrane for socket preservation. The goal is to see if these methods help maintain the shape of the jawbone.

Participant Groups

Group I: Bone Graft + Membrane Experimental Treatment 2 Interventions

Socket preservation sites with bone graft (MinerOss® X Plug) and a non-crosslinked collagen membrane without complete flap closure (secondary intention healing) (n=10)

Group II: Bone Graft Alone Active Control 1 Intervention

Socket preservation sites with bone graft (MinerOss® X Plug) alone without complete flap closure (secondary intention healing) (n=10)

Who Is Running the Clinical Trial?

Harvard School of Dental Medicine

Lead Sponsor

Trials

12

Recruited

630+

BioHorizons, Inc.

Industry Sponsor

Trials

17

Recruited

500+

Camlog Oral Reconstruction Foundation

Collaborator

Trials

5

Recruited

170+