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

Description

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

Study Overview

Study Details

Study overview

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.

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

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

Condition
Nonterminal Premolar Needing Extraction
Intervention / Treatment

-

Contacts and Locations

Aurora

McClain and Schallhorn Periodontics and Implant Dentistry, Aurora, Colorado, United States, 80012-3260

Broomfield

Colorado Gum Care, Broomfield, Colorado, United States, 80020

Boston

The Perio Studio, Boston, Massachusetts, United States, 02108

Fenton

Seven Lakes Periodontics, Fenton, Michigan, United States, 48430

Nashville

Perio & Implant Associates of Middle TN, Nashville, Tennessee, United States, 37215

Houston

Perio Health Professionals, Houston, Texas, United States, 77063-7229

Victoria

Gulf Coast Periodontics, Victoria, Texas, United States, 77904

Kenosha

WisNova Institute of Dental Specialists, Kenosha, Wisconsin, United States, 53144-4292

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

McGuire Institute,

Study Record Dates

2029-11-28