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Vallomix Socket Preservation Study

StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record History

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  1. Notable Primary endpoints: details revised at 1 of 1 entry Show 5 more changesShow less
    • Enrollment closed, study ongoing
    • Interventions: Allograft (Device), Allograft/Xenograft (Device) to Allograft (Device), Allograft/Xenograft (Device)
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 2 of 2 entries
    • Site details revised
  2. Notable Phase: Phase 4 to Not applicablev4
  3. Notable Phase: Not applicable to Phase 4
    • Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jan 2025 to Jan 13, 2025
    • Site details revised
    v3
  4. Notable Start date: Aug 2024 to Jan 2025
    • Eligibility criteria expanded, about 5 words
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This research aims to compare the effectiveness of two bone grafting materials on preserving jawbone integrity after tooth extraction. Following extraction, the jawbone surrounding the removed tooth can shrink, affecting future implant placement. By placing a bone graft material in the extraction socket, we aim to maintain adequate jawbone space for future implants. This study compares how well the mixture of vallos®f (human source bone) and Bio-Oss (animal source bone) \[test\], and vallos® only \[control\] grafting materials work. Participants with at least one tooth planned for extraction and subsequent implant placement are sought for this study. Participants will be randomly assigned to either the mixture of vallos®f and Bio-Oss (test) group or the vallos® only (control) group. Throughout the approximately 2-year study duration, participants will undergo oral exams, x-rays, surgical procedures, and follow-up visits. All participants will undergo routine tooth extraction, bone graft material placement, and dental implant placement. After the crown is placed on the implant, participants will attend follow-up visits. Participation in the study is voluntary, and the alternative is to continue routine dental care. Risks include minor discomfort from procedures such as tooth extraction and implant placement. The major benefit of participation in the study is the preservation of jaw dimensions following extraction, which will simplify the placement of a dental implant.
Trial Details
NCT Number NCT06472453
Lead Sponsor University of Maryland, Baltimore
Conditions
(from sponsor)
Alveolar Ridge Augmentation
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov