Phase
Condition
N/ATreatment
OsteoGen Plug
BioGide
Clinical Study ID
Ages 18-75 All Genders
Study Summary
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
Study Description
Connect with a study center
McClain and Schallhorn Periodontics and Implant Dentistry
Aurora, Colorado 80012-3260
United StatesActive - Recruiting
Colorado Gum Care
Broomfield, Colorado 80020
United StatesActive - Recruiting
The Perio Studio
Boston, Massachusetts 02108
United StatesActive - Recruiting
Seven Lakes Periodontics
Fenton, Michigan 48430
United StatesActive - Recruiting
Perio & Implant Associates of Middle TN
Nashville, Tennessee 37215
United StatesActive - Recruiting
Perio Health Professionals
Houston, Texas 77063-7229
United StatesActive - Recruiting
Gulf Coast Periodontics
Victoria, Texas 77904
United StatesActive - Recruiting
WisNova Institute of Dental Specialists
Kenosha, Wisconsin 53144-4292
United StatesActive - Recruiting
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