Vallomix Socket Preservation Study
NCT Number: NCT06472453
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Alveolar Ridge Augmentation
Interventions: DEVICE: Allograft/Xenograft|DEVICE: Allograft
Sponsor: University of Maryland, Baltimore
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 24
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: SINGLE (OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-08
Completion Date: 2028-06
Locations: University of Maryland School of Dentistry, Baltimore, Maryland, 21231, United States

Summary:
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 the effectiveness of vallomix® (xenogeneic/allogeneic bone) and vallos® (allogeneic bone) grafting materials.

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 vallomix® (test) group or the vallos® (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.

Primary Outcome Measures: Three-dimensional hard and soft tissue change using CBCT/ intraoral scan, Evaluate the efficacies of Alveolar Ridge Preservation in three-dimensional ridge hard and soft tissue change in volumetric and linear measurement using CBCT and intraoral scan over time, Over the course of the study (From the time of study enrollment Alveolar Ridge Preservation [Visit 2] to 1-year post implant-supported crown delivery [Visit 11]).
Secondary Outcome Measures: Comparison of implant positions of digital planning based on the CBCT scan before and after Alveolar Ridge Preservation will be compared., Evaluate the efficacies of Alveolar Ridge Preservation in achieving intended implant placement. The digital planning on the CBCT before and after the e-extraction digital planning, 4-5 months (Before Alveolar Ridge Preservation/ Enrollment [Visit 2] to 4-month follow-up [Visit 7])|Histomorphometric analysis of the bone harvested from the grafted site, Evaluate the bone harvested from the re-grafted site for new bone formation/remaining graft residuals at the time of implant placement (Visit 8) by histomorphometric analysis, 5 months (At the time of implant placement [Visit 8])