OsteoGen Plug vs. Freeze-dried Bone Allograft With Collagen Barrier

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-28

Study Completion Date

2029-11-28

Brief Summary

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The study will be a multi-site, randomized, two-arm, controlled clinical trial using OsteoGen® Plug (Test) vs Freeze-dried Bone Allograft with collagen barrier (Control) for alveolar ridge preservation (ARP) in posterior extraction sites with intact buccal cortical plates.

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Detailed Description

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After tooth extraction and debridement, sockets will be packed with either test product (OGP), or control product (BioGide). Subjects will then undergo follow-up assessments conducted at day 7 (+3 days), day 14 (+3 days), and day 30 (+3 days) for oral exam, PROs, AEs, and complication assessments. Subjects will undergo follow-up assessments conducted at day 60 (+3 days) and day 90 (+3 days), for oral exam, PROs, AEs, complication assessments, standardized PA radiographs. Subjects will undergo follow-up assessments conducted at day 120 (+3 days) for oral exam, PROs, AEs, complication assessments, standardized PA radiograph, intraoral scan, and CBCT.

OPTIONAL Subjects will undergo follow-up assessments conducted at day 135 (+14 days) for oral exam, AEs, complication assessments, histologic core procurement, additional grafting assessment, prosthetic driven implant placement assessment.

Subjects will undergo follow-up assessments conducted at day 143 (+5 days) for oral exam, AEs, end of study.

Conditions

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Nonterminal Premolar Needing Extraction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

a multi-site, randomized, two-arm, controlled clinical trial using OsteoGen® Plug (Test) vs Freeze-dried Bone Allograft with collagen barrier

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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OsteoGen Plug

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 Type EXPERIMENTAL

OsteoGen Plug

Intervention Type DEVICE

OsteoGen® Plug is contoured to fill the three roots of the socket. Plug is delivered dry into a thoroughly debrided and actively bleeding socket. The OsteoGen® Plug is condensed firmly into the socket.

BioGide

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

Group Type ACTIVE_COMPARATOR

BioGide

* Subjects with reported allergy or hypersensitivity to any of the products to be used in the study.
* Subjects with untreated / active periodontal disease.
* Subjects with vesiculobullous processes or other similar chronic oral lesions / conditions resulting in gingival irritation, discomfort/pain, or erosions.
* Tobacco/Cannabis users including cigarettes, vape, cigars, or smokeless tobacco.
* Uncontrolled medical conditions (e.g., diabetes mellitus, hypertension, cancer)
* Subjects who are lactating or pregnant or planning to become pregnant through their projected study duration.
* Subjects who would require a tissue supported interim prosthesis i.e. acrylic / valplast RPD (tooth supported interim prostheses i.e. essix retainers are acceptable)
* Subjects with long-term history of oral bisphosphonates (\> 10 years).
* Subjects with a history of intravenous bisphosphonates.
* Subjects taking medications known to affect gingival conditions. (e.g., hyperplasia)
* Subjects taking corticosteroids or immunosuppressants on a regular basis prior to baseline examination.
* Subjects taking anticoagulant medications such as warfarin or Plavix or Eliquis who are not medically cleared to hold medication prior to and during procedure.
* Subjects participating in other clinical studies involving therapeutic intervention (either medical or dental).
* Subjects, who in the opinion of the investigator, for any reason other than those listed above, will not be able to complete the study per protocol.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No