NCT05400213

Wound Healing Following Tooth Extraction and Ridge Preservation Using DFDBA Alone in Particulate Fiber Form and in Combination With Xenograft

Randomized Controlled Trial of Wound Healing Following Tooth Extraction and Ridge Preservation Using Decalcified Freeze-dried Bone Allograft (DFDBA) Alone in Particulate Fiber Form and in Combination With Xenograft

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 102 (actual)
• Sponsor: The University of Texas Health Science Center at San Antonio · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

The primary aim of the study is to determine the amount of newly formed vital bone, residual graft material, and "connective tissue/other" 18 to 20 weeks after ridge preservation is performed using DFDBA fibers alone, DFDBA particulate alone, a combination of xenograft and DFDBA particulate, or a combination of xenograft and DFDBA fibers.

Detailed description

The study plan is to extract non-molar teeth and graft with the various graft materials. Each subject will provide a single non-molar tooth site for study treatment. Following approx. 18-20 weeks of healing, the study team will harvest a core biopsy at the time of implant placement. The implant osteotomy is prepared with a trephine drill and the core inside the trephine is placed in 10% formalin for future processing and histomorphometric analysis. The core biopsy will be evaluated for the primary histologic outcome of % vital bone formation and the secondary histologic outcomes of % residual graft material, and % "CT/other" (fibrous tissue and marrow space). The study team will also evaluate the following secondary clinical outcomes using a custom measuring stent for each subject: change in ridge width; change in buccal ridge height and change in lingual ridge height. During the 18 to 20-week healing period, patients will be followed as needed per standard care to evaluate healing.

Conditions

• Dental Extraction
• Wound Heal

Interventions

Type	Name	Description
DEVICE	Vallos (DCP)	Demineralized freeze-dried bone allograft (DFBA) in a small particle form
DEVICE	Vallomix (DCF)	A combination of cow-derived xenograft and human-derived DFDBA particulate
DEVICE	Vallos-F (DPX)	Demineralized freeze-dried bone allograft (DFDBA) in a fiber form
DEVICE	Vallomix-F (DFX)	A combination of cow-derived xenograft and human-derived DFDBA fibers

Timeline

• Start date: 2022-08-02
• Primary completion: 2024-08-23
• Completion: 2024-12-18
• First posted: 2022-06-01
• Last updated: 2025-06-19
• Results posted: 2025-06-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study