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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial compares two methods of preserving bone after tooth extraction: using a bone graft alone (MinerOss® X Plug) or with an added collagen membrane (Striate+ Membrane). The focus is on evaluating new bone formation in each method to aid future dental implants. Suitable participants are those needing a single-rooted tooth removed and having healthy surrounding teeth and bone. As an unphased trial, this study allows participants to contribute to valuable research that could enhance dental treatments.

Will I have to stop taking my current medications?

The trial requires that participants are not currently taking medications that affect bone turnover or blood thinners. If you are on such medications, you may need to stop them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

A previous study found that the MinerOss® X Plug works well in bone grafting procedures and is generally well-tolerated by patients, with no significant reports of serious side effects. This suggests it is safe for use in dental procedures, such as preserving the socket after tooth removal.

Research shows that the Striate+ Membrane has been used successfully in similar procedures, with patients not reporting major safety issues when it covers grafts. Overall, both the MinerOss® X Plug and the Striate+ Membrane have a good safety record in dental settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the MinerOss® X Plug for socket preservation because it offers a new approach to bone grafting by using a specialized bone graft plug. Unlike traditional bone grafts that require complete flap closure, the MinerOss® X Plug allows for healing by secondary intention, potentially simplifying the procedure. Additionally, when combined with a non-crosslinked collagen membrane, it might enhance bone regeneration and support better outcomes. This could mean a less invasive and more effective option for preserving the bone structure after tooth extraction.

What evidence suggests that this trial's treatments could be effective for socket preservation?

Research has shown that MinerOss® X Plug, composed of 80% cow bone and 20% collagen, helps maintain bone structure after tooth extraction. This preservation is crucial for keeping the bone's shape. Studies have found it effective in maintaining the height and shape of the jawbone after teeth removal. In this trial, one group will receive the MinerOss® X Plug alone for socket preservation.

Animal studies suggest that the Striate+ Membrane promotes bone growth and prevents unwanted tissue from encroaching on the area. In this trial, another group will receive both the MinerOss® X Plug and the Striate+ Membrane. Together, these treatments aim to support effective bone healing and recovery after tooth extraction. ^{1 2 6 7 8}

Who Is on the Research Team?

David M Kim, DDS, DMSc

Principal Investigator

Harvard School of Dental Medicine

Are You a Good Fit for This Trial?

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

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

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05838651

Socket Preservation With BioHorizon's Striate+ Membrane ... MinerOss® X Plug: A xenograft composed of 80% bovine cancellous particulate and 20% bovine Type I collagen. The 20% collagen prevents particulate migration.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10474704/

Effect of three different grafting materials on immediate ... This study compared the effectiveness of three bone grafting materials used for treating class II fresh extraction sockets in the esthetic zone ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12194317/

Evaluation of the Effectiveness of the Socket Preservation ... Results: The results showed that the allogeneic material was more effective in preserving alveolar buccal height and was probably more rapidly ...

4. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/78/NCT05419778/Prot_SAP_000.pdf

Histological evaluation of alveolar ridge preservation using ... Histological evaluation of alveolar ridge preservation using MInerOss® versus Osteogen plug® bone graft techniques: clinical study analysis part II.

5. mdpi.com mdpi.com/2304-6767/11/9/215

Success of Xenografts in Alveolar Ridge Preservation ... Vital information that would improve outcomes of ARP procedures include how much bone is formed, which biomaterials resorb the most, and which ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8158510/

Bone Grafts and Substitutes in Dentistry: A Review of Current ... This review will critically present the various dental bone graft and substitute materials that have been used to achieve a successful dental implant.

7. biohorizons.com biohorizons.com/products/MinerOssXPlug

MinerOss X Plug | Xenograft for Bone Grafting MinerOss X Plugs are designed to simplify and streamline the grafting process with two size options conveniently shaped for a variety of graft sites.

8. withpower.com withpower.com/trial/phase-socket-preservation-4-2023-4780d

MinerOss X Plug + Striate+ Membrane for Socket ... The primary objective of this proposed clinical trial is to provide detailed comparison and evidence of new bone formation in patients undergoing socket ...