Vallomix Socket Preservation Study
- Conditions
- Alveolar Ridge Augmentation
- Interventions
- Device: Allograft/XenograftDevice: Allograft
- Registration Number
- NCT06472453
- Lead Sponsor
- University of Maryland, Baltimore
- Brief 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 24
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Alveolar ridge preservation with Allograft/Xenograft group Allograft/Xenograft The patients in both groups will go through the same treatment but with two different bone grafting materials depending on the assigned group. The patients in this group will have alveolar ridge preservation with demineralized cortical allograft and xenograft bone substitute called "vallomix". Alveolar ridge preservation with Allograft group Allograft The patients in both groups will go through the same treatment but with two different bone grafting materials depending on the assigned group. The patients in this group will have alveolar ridge preservation with mineralized cortico-cancellous bone substitute called "vallos".
- Primary Outcome Measures
Name Time Method Three-dimensional hard and soft tissue change using CBCT/ intraoral scan 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]). 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
- Secondary Outcome Measures
Name Time Method Comparison of implant positions of digital planning based on the CBCT scan before and after Alveolar Ridge Preservation will be compared. 4-5 months (Before Alveolar Ridge Preservation/ Enrollment [Visit 2] to 4-month follow-up [Visit 7]) 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
Histomorphometric analysis of the bone harvested from the grafted site 5 months (At the time of implant placement [Visit 8]) 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
Trial Locations
- Locations (1)
University of Maryland School of Dentistry
🇺🇸Baltimore, Maryland, United States