About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Provision of informed consent
At least 18 years old
In need of one posterior tooth (premolar or molar), excluding third molar molars, planned for extraction and replacement with a dental implant
Type I or II extraction socket/ ridge identified at the time of enrolment with cone-beam CT scan
Disqualifiers
Insufficient interocclusal or interdental space to allow for an implant- supported prosthesis
Previous interventions performed involving soft and/or bone grafting in the study site
Active treated caries
Uncontrolled periodontal disease present
Trial design
Parallel
Treatments tested in this trial
Allograft/Xenograft
DeviceAlveolar ridge preservation of a single extraction socket site with a mixture of demineralized cortical bone substitute vallos®" and xenograft Bio-Oss®.
Allograft
DeviceAlveolar ridge preservation of a single extraction socket site with vallos® (mineralized cortico-cancellous bone substitute)
Treatment groups
Trial outcomes
Primary outcomes
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
Secondary outcomes
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
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
Sponsors and contacts
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