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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Nonterminal Premolar Needing Extraction
• Intervention / Treatment: Device: OsteoGen Plug; Device: BioGide

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.

• Study Type: Interventional
• Enrollment (Estimated): 70
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Colorado
    • Aurora, Colorado, United States, 80012-3260
      • McClain and Schallhorn Periodontics and Implant Dentistry
    • Broomfield, Colorado, United States, 80020
      • Colorado Gum Care
  • Massachusetts
    • Boston, Massachusetts, United States, 02108
      • The Perio Studio
  • Michigan
    • Fenton, Michigan, United States, 48430
      • Seven Lakes Periodontics
  • Nebraska
    • La Vista, Nebraska, United States, 68128
      • Metro West Orthodontics and Periodontics
  • Tennessee
    • Nashville, Tennessee, United States, 37215
      • Perio & Implant Associates of Middle TN
  • Texas
    • Houston, Texas, United States, 77063-7229
      • Perio Health Professionals
    • Victoria, Texas, United States, 77904
      • Gulf Coast Periodontics
  • Wisconsin
    • Kenosha, Wisconsin, United States, 53144-4292
      • WisNova Institute of Dental Specialists

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: OsteoGen Plug; 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.
Active Comparator: BioGide; This product is SOC treatment and will be used per packaging instructions.	Device: BioGide; BioGide is a resorbable collagen membrane

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
New bone formation	new bone formation will be determined by Cone Beam Cat Scan (CBCT) at Day 120	120 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in ridge height compared to screening as determined by Cone Beam Cat Scan (CBCT)	two CBCTs will be compared, one from screening, the other at 120 days.	120 days

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in ridge width compared to screening at 3mm and 5mm below crest	two CBCTs will be compared, one from screening, the other at 120 days.	120 days
Volumetric analysis of soft tissue/ridge height and width via intraoral scans	Intraoral scans will be compared to baseline, pre-surgery and 120 days.	120 days
Histologic assessment of NBF (new bone formation), RG (residual graft particle) and connective tissue at 4 months if implant is placed	histology samples will be collected 4 months post implant placement for analysis on bone growth,	4 months post implant placement
wound closure assessment	wound closure will be assessed at all post surgical visits.	120 days
number of treatment sites requiring additional grafting at time of implant placement	oral exam of dentition to determine if any additional grafting is needed to treatment sites.	During procedure (time of implant placement)
cost effectiveness analysis	comparison of experimental procedure vs. standard treatment.	120 days
baseline buccal plate thickness influence on outcomes	buccal plate thickness documented by CBCT will be compared to outcomes.	120 days
change in phenotype	the change in soft and hard tissue thickness supporting structures of the teeth.	120 days
time comparison between treatment groups from post extraction to ARP procedure completion (final suture)	time will be document for both arms from start of surgery to last suture being placed	surgical visit
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.	two CBCTs will be compared, one from screening, the other at 120 days.	120 days
complication type and incidence rates	complications will be collected at all visits post surgery	120 days
Prosthetic driven implant feasibility assessment	a determination if implant could have been placed without additional grafting.	120 days
Safety and tolerability/biocompatibility:Adverse events	adverse events will be collected from baseline visit through end of study	120 days
Patient demographics and robust health history influence outcomes	patient demographics will be collected at screening and compared to outcomes at Day 120	120 days
Patient reported outcomes (pain, satisfaction)	PROs will be collected from baseline to day 120 to determine level of pain on a scale from 1 (no discomfort) to 10 (as much discomfort as i have ever felt) and satisfaction on a scale of 0 (completely dissatisfied) to 10 (completely satisfied).	120 days
Clinician reported outcomes for usability (ease of use, time for each graft procedure, site vascularity)	clinicians will be asked to provide their opinions on useability of each product. Ease of use scale 0 (completely dissatisfied) to 10 (completely satisfied) and vascularity rating from 1 (avascular blood flow) to 5 (blood flow readily apparent without cortical penetration)	visit 2 post surgery
Long term implant assessments	optional assessment if an implant is placed at some point in the future.Details not yet specified.	post implant placement (outside of study after 120 days)
histology cores if implant placement in future	optional additional histology assessments may be done if implant is placed at some point in the future.	post implant placement (outside of study after 120 days)

Collaborators and Investigators

• Sponsor: McGuire Institute
• Collaborators: Impladent LTD

Study record dates

Study Major Dates

• Study Start (Actual): March 28, 2024
• Primary Completion (Estimated): June 30, 2026
• Study Completion (Estimated): November 28, 2027

Study Registration Dates

• First Submitted: May 29, 2024
• First Submitted That Met QC Criteria: June 3, 2024
• First Posted (Actual): June 7, 2024

Study Record Updates

• Last Update Posted (Actual): May 29, 2026
• Last Update Submitted That Met QC Criteria: May 27, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Other Study ID Numbers: OGP2024-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No