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

Launched by MCGUIRE INSTITUTE · Jun 3, 2024

Keywords

ClinConnect Summary

This clinical trial is looking at two different options to help preserve the bone in the jaw after a nonterminal premolar tooth is extracted, with the goal of making it easier to place a dental implant later. One option being tested is called OsteoGen® Plug, and the other is a freeze-dried bone allograft combined with a collagen barrier. The study will involve participants who are between 18 and 75 years old, have a specific type of tooth that needs to be removed, and have enough healthy bone structure around the tooth.

To join the study, participants should be able to care for their own oral hygiene and not have certain medical conditions, such as untreated gum disease or allergies to the products used in the trial. During the study, participants will receive one of the two treatments and will be monitored to see how well their jawbone is preserved. This trial is currently recruiting participants, and it's a great opportunity for those who are planning to get a dental implant after removing a problematic tooth.

Gender

ALL

Eligibility criteria

• 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.