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Clinical Trials in the USA / NCT06447844
Active, not recruiting Not applicable

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

NCT06447844 · tracked via the Priya Life Science USA tracker
Sponsor
McGuire Institute
Phase
Not applicable
Started
2024-03-28
Last updated
2026-05-29

Condition(s) studied

Nonterminal Premolar Needing Extraction

Investigational drug(s) / intervention(s)

OsteoGen PlugBioGide

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.

BioGide: BioGide is a resorbable collagen membrane

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

Sex
ALL
Min age
18 Years
Max age
75 Years
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.

Primary outcome measure(s)

Trial sites (9)

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

More McGuire Institute trials in the USA

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06447844 on ClinicalTrials.gov ↗ ← All trials in the USA