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Bone Graft

OsteoGen Plug vs. Bone Allograft for Wisdom Tooth Extraction

N/A

Recruiting

Research Sponsored by McGuire Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Subjects aged 18 to 75 years

Proposed treatment site must have intact adjacent natural teeth (no adjacent edentulous sites or implants)

Must not have

Subjects taking medications known to affect gingival conditions (e.g., hyperplasia)

Subjects with untreated/active periodontal disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 4 months post implant placement

Awards & highlights

Summary

"This trial will compare two different treatments for preserving the bone in the back of the mouth after a tooth extraction. One treatment uses OsteoGen® Plug and the other uses Freeze-dried Bone Al

Who is the study for?

This trial is for individuals who need their wisdom teeth removed and have a healthy outer wall of the socket. It's not suitable for those with certain health conditions or habits that could affect bone healing.

What is being tested?

The study compares two methods of preserving jawbone after wisdom tooth removal: OsteoGen Plug (a synthetic material) versus freeze-dried bone graft with a collagen barrier.

What are the potential side effects?

Possible side effects may include discomfort, swelling, infection at the extraction site, and reactions to materials used in either method.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 75 years old.

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The teeth next to my treatment site are natural and healthy.

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I can take care of my own oral hygiene without help.

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I need a nonterminal premolar tooth extracted and plan to get an implant.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am taking medication that can affect my gum health.

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I have active gum disease that hasn't been treated.

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I have chronic mouth sores or conditions causing gum pain or erosion.

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I need a temporary dental prosthesis not supported by teeth.

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I have been taking oral bisphosphonates for more than 10 years.

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I have received intravenous bisphosphonates in the past.

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I regularly take corticosteroids or immunosuppressants.

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I do not have any uncontrolled health conditions like diabetes or high blood pressure.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 4 months post implant placement

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~4 months post implant placement

This trial's timeline: 3 weeks for screening, Varies for treatment, and 4 months post implant placement for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

New bone formation

Secondary study objectives

Change in ridge height compared to screening as determined by Cone Beam Cat Scan (CBCT)

Other study objectives

Change in ridge width compared to screening at 3mm and 5mm below crest

Change in ridge width compared to screening at crest as determined by CBCT. Change in ridge width compared to baseline screening at crest as determined by CBCT. Change in ridge width compared to screening at crest as determined by CBCT.

Clinician reported outcomes for usability (ease of use, time for each graft procedure, site vascularity)

+15 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: OsteoGen PlugExperimental Treatment1 Intervention

OsteoGen® Plug (OGP) is a combination of bovine achilles tendon collagen matrix sourced from Australia or New Zealand and bioactive resorbable calcium apatite crystals intended for ARP. It is provided to clinicians in 3 different sizes to be placed in extraction socket.

Group II: BioGideActive Control1 Intervention

This product is SOC treatment and will be used per packaging instructions.

0 / 12Eligibility criteria met

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Who is running the clinical trial?

Impladent LTDUNKNOWN

McGuire InstituteLead Sponsor

6 Previous Clinical Trials

318 Total Patients Enrolled

~47 spots leftby Sep 2025

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