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

Last updated: June 3, 2024
Sponsor: McGuire Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

N/A

Treatment

OsteoGen Plug

BioGide

Clinical Study ID

NCT06447844
OGP2024-01
  • Ages 18-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Subjects 18 to 75-yrs of age.

  • Subjects with a nonterminal premolar in need of extraction with intention to pursueimplant 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 areacceptable which do not perforate the cortical plate).

  • Proposed treatment site must have intact adjacent natural teeth. (no adjacentedentulous sites or implants).

  • Subjects can provide self-care (oral hygiene) without disabilities requiringassistance 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

Exclusion Criteria:

  • Subjects with reported allergy or hypersensitivity to any of the products to be usedin 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 theirprojected study duration.

  • Subjects who would require a tissue supported interim prosthesis i.e. acrylic /valplast RPD (tooth supported interim prostheses i.e. essix retainers areacceptable)

  • 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 tobaseline examination.

  • Subjects taking anticoagulant medications such as warfarin or Plavix or Eliquis whoare 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 thoselisted above, will not be able to complete the study per protocol.

Study Design

Total Participants: 70
Treatment Group(s): 2
Primary Treatment: OsteoGen Plug
Phase:
Study Start date:
March 28, 2024
Estimated Completion Date:
November 28, 2029

Study 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.

Connect with a study center

  • McClain and Schallhorn Periodontics and Implant Dentistry

    Aurora, Colorado 80012-3260
    United States

    Active - Recruiting

  • Colorado Gum Care

    Broomfield, Colorado 80020
    United States

    Active - Recruiting

  • The Perio Studio

    Boston, Massachusetts 02108
    United States

    Active - Recruiting

  • Seven Lakes Periodontics

    Fenton, Michigan 48430
    United States

    Active - Recruiting

  • Perio & Implant Associates of Middle TN

    Nashville, Tennessee 37215
    United States

    Active - Recruiting

  • Perio Health Professionals

    Houston, Texas 77063-7229
    United States

    Active - Recruiting

  • Gulf Coast Periodontics

    Victoria, Texas 77904
    United States

    Active - Recruiting

  • WisNova Institute of Dental Specialists

    Kenosha, Wisconsin 53144-4292
    United States

    Active - Recruiting

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