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Demineralized Bone Allograft Fibers Versus Particulate In Sinus Augmentation
The purpose of this clinical trial is to assess if the addition of DFDBA fibers to DBBM results in greater vital bone formation than the addition of DFDBA particles to DBBM. The study team will examine the effects of the addition of DFDBA fibers to DBBM on vital bone formation. Specifically, we will assess histologically the percent vital bone formation with each of the groups during implant placement, six months after the sinus augmentation procedure. We will also evaluate the radiographic volume achieved with both groups of materials.
Conditions:
🦠 Bone Loss in Jaw
🗓️ Study Start (Actual) 25 September 2023
🗓️ Primary Completion (Estimated) May 2025
✅ Study Completion (Estimated) May 2026
👥 Enrollment (Estimated) 26
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 San Antonio, Texas, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Patients between age 18 and 89
    • * Patients needing sinus augmentation to support implant placement in the posterior maxilla
    • * Patients must be nonsmokers, former smokers, or current smokers who smoke \<10 cigarettes per day, by self-report
    • * Female patients who have undergone a hysterectomy, tubal ligation, or menopause, and non- pregnant women of child-bearing potential.

    Exclusion Criteria:

    • * Patients who disclose that they will not be able to cooperate with the follow-up schedule.
    • * Patients who are mentally incompetent, prisoners, or pregnant (as obtained via chart review or self-report)
    • * Pregnant women or women intending to become pregnant during study period
    • * Smokers who smoke \> 10 cigarettes per day
Ages Eligible for Study: 18 Years to 89 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 7 December 2023
  • First Submitted that Met QC Criteria 7 December 2023
  • First Posted 18 December 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 7 December 2023
  • Last Update Posted 18 December 2023
  • Last Verified December 2023
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