OsteoGen Plug vs. Freeze-dried Bone Allograft With Collagen Barrier (NCT06447844) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
OsteoGen Plug vs. Freeze-dried Bone Allograft With Collagen Barrier
United States70 participantsStarted 2024-03-28
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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 prosthe…