← Back to Search

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.Check my eligibility
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.See study design
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
Select...
I am between 18 and 75 years old.
Select...
The teeth next to my treatment site are natural and healthy.
Select...
I can take care of my own oral hygiene without help.
Select...
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:
Select...
I am taking medication that can affect my gum health.
Select...
I have active gum disease that hasn't been treated.
Select...
I have chronic mouth sores or conditions causing gum pain or erosion.
Select...
I need a temporary dental prosthesis not supported by teeth.
Select...
I have been taking oral bisphosphonates for more than 10 years.
Select...
I have received intravenous bisphosphonates in the past.
Select...
I regularly take corticosteroids or immunosuppressants.
Select...
I do not have any uncontrolled health conditions like diabetes or high blood pressure.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
New bone formation
Secondary outcome measures
Change in ridge height compared to screening as determined by Cone Beam Cat Scan (CBCT)
Other outcome measures
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.

Find a Location

Who is running the clinical trial?

Impladent LTDUNKNOWN
McGuire InstituteLead Sponsor
6 Previous Clinical Trials
318 Total Patients Enrolled
~0 spots leftby Jul 2024