Clinical trial NCT06472453: Vallomix Socket Preservation Study
Official title: Prospective Comparative Evaluation of Alveolar Ridge Preservation: Mixing Allograft With Xenograft VS. Allograft Alone in Atraumatic Extraction Sockets
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Alveolar Ridge Augmentation
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2024-06-25
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion criteria:

1. Provision of informed consent
2. At least 18 years old
3. In need of one posterior tooth (premolar or molar), excluding third molar molars, planned for extraction and replacement with a dental implant
4. Type I or II extraction socket/ ridge identified at the time of enrolment with cone-beam CT scan
5. At least one retained natural tooth adjacent to the study site

Exclusion criteria

1. Insufficient interocclusal or interdental space to allow for an implant- supported prosthesis
2. Previous interventions performed involving soft and/or bone grafting in the study site
3. Active treated caries
4. Uncontrolled periodontal disease present
5. Evidence of active periapical, radicular, or endodontic lesions on teeth adjacent to study site
6. History of recent extraction of an adjacent tooth (mesial and distal) to study site within 6 months of enrollment
7. Current smoker with self-reported history of more than 10 cigarettes or equivalent per day
8. Self-reported use of smokeless tobacco or e-cigarette
9. Self-reported history of current alcohol or drug abuse
10. 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
11. Systemic corticosteroids or any other medication that would influence bone metabolism, post-operative healing, and/or osseointegration

Primary outcomes:
measure: Three-dimensional hard and soft tissue change using CBCT/ intraoral scan
timeFrame: 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 outcomes:
measure: Comparison of implant positions of digital planning based on the CBCT scan before and after Alveolar Ridge Preservation will be compared.
timeFrame: 4-5 months (Before Alveolar Ridge Preservation/ Enrollment [Visit 2] to 4-month follow-up [Visit 7])
measure: Histomorphometric analysis of the bone harvested from the grafted site
timeFrame: 5 months (At the time of implant placement [Visit 8])
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland School of Dentistry
state: Maryland
Study officials:
References: