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

NCT06447844 | Active Not Recruiting FDA Device

• 1 other identifier: OGP2024-01
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 9

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.

Conditions

Nonterminal Premolar Needing Extraction

Outcome Measures

Primary Outcomes (1)

• New bone formation

  new bone formation will be determined by Cone Beam Cat Scan (CBCT) at Day 120

  120 days

Secondary Outcomes (1)

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

  120 days

Other Outcomes (18)

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

  120 days

• Volumetric analysis of soft tissue/ridge height and width via intraoral scans

  120 days

• Histologic assessment of NBF (new bone formation), RG (residual graft particle) and connective tissue at 4 months if implant is placed

  4 months post implant placement

Study Arms (2)

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.

Device: OsteoGen Plug

BioGide

ACTIVE COMPARATOR

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

Device: BioGide

Interventions

BioGide DEVICE

BioGide is a resorbable collagen membrane

BioGide

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.

OsteoGen Plug

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGuire Institute: lead
• Impladent LTD: collaborator

Study Sites (9)

McClain and Schallhorn Periodontics and Implant Dentistry

Aurora, Colorado, 80012-3260, United States

Location

Colorado Gum Care

Broomfield, Colorado, 80020, United States

Location

The Perio Studio

Boston, Massachusetts, 02108, United States

Location

Seven Lakes Periodontics

Fenton, Michigan, 48430, United States

Location

Metro West Orthodontics and Periodontics

La Vista, Nebraska, 68128, United States

Location

Perio & Implant Associates of Middle TN

Nashville, Tennessee, 37215, United States

Location

Perio Health Professionals

Houston, Texas, 77063-7229, United States

Location

Gulf Coast Periodontics

Victoria, Texas, 77904, United States

Location

WisNova Institute of Dental Specialists

Kenosha, Wisconsin, 53144-4292, United States

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 7, 2024
• Study Start: March 28, 2024
• Primary Completion (Estimated): July 28, 2026
• Study Completion (Estimated): November 28, 2029
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

US (9)