---
title: OsteoGen Plug vs. Freeze-dried Bone Allograft With Collagen Barrier
nct_id: NCT06447844
overall_status: ACTIVE_NOT_RECRUITING
phase: NA
sponsor: McGuire Institute
study_type: INTERVENTIONAL
primary_condition: Nonterminal Premolar Needing Extraction
countries: United States
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06447844.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06447844"
ct_last_update_post_date: 2026-03-10
last_seen_at: "2026-05-12T07:22:47.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# OsteoGen Plug vs. Freeze-dried Bone Allograft With Collagen Barrier

**Official Title:** OsteoGen® Plug vs Freeze-dried Bone Allograft With Collagen Barrier for Alveolar Ridge Preservation (ARP): A Randomized Controlled Trial

**NCT ID:** [NCT06447844](https://clinicaltrials.gov/study/NCT06447844)

## Key Facts

- **Status:** ACTIVE_NOT_RECRUITING
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 70
- **Lead Sponsor:** McGuire Institute
- **Collaborators:** Impladent LTD
- **Conditions:** Nonterminal Premolar Needing Extraction
- **Start Date:** 2024-03-28
- **Completion Date:** 2029-11-28
- **CT.gov Last Update:** 2026-03-10

## Brief Summary

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.

## Detailed Description

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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

* Subjects 18 to 75-yrs of age.
* Subjects with a nonterminal premolar in need of extraction with intention to pursue implant replacement.
* Proposed treatment site must have intact buccal cortical plates \> 1 mm in thickness (buccal bone dehiscence up to 25% root length is permissible). Apical lesions are acceptable which do not perforate the cortical plate).
* Proposed treatment site must have intact adjacent natural teeth. (no adjacent edentulous sites or implants).
* Subjects can provide self-care (oral hygiene) without disabilities requiring assistance with daily oral hygiene measures.
* Subjects will have read, understood, and signed an institutional review board (IRB) approved Informed Consent Form (ICF).
* Subjects must be able and willing to follow study procedures and instructions.

Exclusion Criteria:

* 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.
```

## Arms

- **OsteoGen Plug** (EXPERIMENTAL) — 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.
- **BioGide** (ACTIVE_COMPARATOR) — This product is SOC treatment and will be used per packaging instructions.

## Interventions

- **OsteoGen Plug** (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** (DEVICE) — BioGide is a resorbable collagen membrane

## Primary Outcomes

- **New bone formation** _(time frame: 120 days)_ — new bone formation will be determined by Cone Beam Cat Scan (CBCT) at Day 120

## Secondary Outcomes

- **Change in ridge height compared to screening as determined by Cone Beam Cat Scan (CBCT)** _(time frame: 120 days)_

## Locations (9)

- McClain and Schallhorn Periodontics and Implant Dentistry, Aurora, Colorado, United States
- Colorado Gum Care, Broomfield, Colorado, United States
- The Perio Studio, Boston, Massachusetts, United States
- Seven Lakes Periodontics, Fenton, Michigan, United States
- Metro West Orthodontics and Periodontics, La Vista, Nebraska, United States
- Perio & Implant Associates of Middle TN, Nashville, Tennessee, United States
- Perio Health Professionals, Houston, Texas, United States
- Gulf Coast Periodontics, Victoria, Texas, United States
- WisNova Institute of Dental Specialists, Kenosha, Wisconsin, United States

## Recent Field Changes (last 30 days)

- `results.hasResults` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `locations.mcclain and schallhorn periodontics and implant dentistry|aurora|colorado|united states` — added _(2026-05-12)_
- `locations.colorado gum care|broomfield|colorado|united states` — added _(2026-05-12)_
- `locations.the perio studio|boston|massachusetts|united states` — added _(2026-05-12)_
- `locations.seven lakes periodontics|fenton|michigan|united states` — added _(2026-05-12)_
- `locations.metro west orthodontics and periodontics|la vista|nebraska|united states` — added _(2026-05-12)_
- `locations.perio & implant associates of middle tn|nashville|tennessee|united states` — added _(2026-05-12)_
- `locations.perio health professionals|houston|texas|united states` — added _(2026-05-12)_
- `locations.gulf coast periodontics|victoria|texas|united states` — added _(2026-05-12)_
- `locations.wisnova institute of dental specialists|kenosha|wisconsin|united states` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06447844.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06447844*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*