Vallomix Socket Preservation Study
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Allograft/Xenograft, Allograft.
- Who it may be relevant to
- Registry conditions: Alveolar Ridge Augmentation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Comparative Evaluation of Alveolar Ridge Preservation: Mixing Allograft With Xenograft VS. Allograft Alone in Atraumatic Extraction Sockets
Overview
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.
Interventions
- Device Allograft/Xenograft
Alveolar ridge preservation of a single extraction socket site with a mixture of demineralized cortical bone substitute vallos®" and xenograft Bio-Oss®. - Device Allograft
Alveolar ridge preservation of a single extraction socket site with vallos® (mineralized cortico-cancellous bone substitute)
Primary outcome measures
- Three-dimensional hard and soft tissue change using CBCT/ intraoral scan [Time frame: 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 (2)
- Comparison of implant positions of digital planning based on the CBCT scan before and after Alveolar Ridge Preservation will be compared. [Time frame: 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 [Time frame: 5 months (At the time of implant placement [Visit 8])]
Eligibility criteria
Inclusion criteria
- 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
- At least one retained natural tooth adjacent to the study site
Exclusion criteria
- 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
- Evidence of active periapical, radicular, or endodontic lesions on teeth adjacent to study site
- History of recent extraction of an adjacent tooth (mesial and distal) to study site within 6 months of enrollment
- Current smoker with self-reported history of more than 10 cigarettes or equivalent per day
- Self-reported use of smokeless tobacco or e-cigarette
- Self-reported history of current alcohol or drug abuse
- Systemic or local disease or condition that would compromise bone metabolism, post-operative healing and/or osseointegration e.g. uncontrolled diabetes with self-reported most recent HbA1c > 8.0 within last six-month
- Systemic corticosteroids or any other medication that would influence bone metabolism, post-operative healing, and/or osseointegration
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
United States · 1 center
- University of Maryland School of Dentistry — Baltimore
Identifiers
NCT: NCT06472453 · HP-00110704 · SAP# 101-080