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NCT07091448 · ClinicalTrials.gov registry record · Phase 4
Biotivity A-C Membrane Socket Preservation Study
A Phase 4 study, sponsored by University of Maryland, Baltimore.
- Not yet
- Registry status
- Phase 4
- Development phase
- 12
- Enrollment target
NCT07091448: Clinical Trial Phase 4 study, sponsored by University of Maryland, Baltimore.
NCT07091448 is a Phase 4 study that has not yet begun recruiting, run by University of Maryland, Baltimore. The registered enrollment target is 12 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07091448, a Phase 4 study, has not yet begun recruiting, sponsored by University of Maryland, Baltimore.
- NOT YET RECRUITING
- Registry status
- Phase 4
- Development phase
- 12 participants
- Enrollment target
Study Summary
This is a prospective, randomized controlled pilot clinical trial evaluating the efficacy of a human placental-derived amnion chorion membrane (Biotivity™ A/C Plus Membrane) versus a conventional collagen membrane in alveolar ridge preservation (ARP) following atraumatic extraction of single posterior teeth. A total of 12 subjects will be enrolled at the University of Maryland School of Dentistry. The study aims to assess both soft tissue wound healing and hard/soft tissue dimensional changes over a 5-month period prior to dental implant placement. Throughout the approximately 6-month 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 and barrier placement, and dental implant placement. 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.
Primary Outcome
Wound healing will be assessed during post-surgery follow-up visits using the Early Wound Healing Index (Wachtel et al., 2003), which classifies flap closure into five categories (1 = complete closure, no fibrin; 5 = necrosis), and Wound Healing Index (WHI) described by Huang (2025 ) with three categories (1 = uneventful healing with no gingival edema, erythema, suppuration, patient dis-comfort, or flap dehiscence; 2 = uneventful healing with slight gingival edema, erythema, patient discomfort, o
Interventions
- DEVICE Amnion chorion membrane
- DEVICE Collagen membrane
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2026-04-01 |
| Est. Completion | 2028-10-31 |
| Phase | Phase 4 |
What is known before NCT07091448 opens enrollment
NCT07091448 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 2 interventions - of which Amnion chorion membrane is the first listed.
NCT07091448 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07091448 about?
NCT07091448 is a clinical study titled "Biotivity A-C Membrane Socket Preservation Study". This is a prospective, randomized controlled pilot clinical trial evaluating the efficacy of a human placental-derived amnion chorion membrane (Biotivity™ A/C Plus Membrane) versus a conventional collagen membrane in alveolar ridge preservation (ARP) following atraumatic extraction of single posteri...
What is the current status of trial NCT07091448?
This trial is currently not yet recruiting. It is a Phase 4 study. The enrollment target is 12 participants. The study started on 2026-04-01. Estimated completion is 2028-10-31.
What interventions are being tested in trial NCT07091448?
The interventions under investigation include: Amnion chorion membrane (DEVICE), Collagen membrane (DEVICE).
Who is sponsoring clinical trial NCT07091448?
This trial is sponsored by University of Maryland, Baltimore, which has 560 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07091448's enrollment target sits among peer trials
12 1913th of 2000 higher than 70 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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