Vallomix Socket Preservation Study

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Maryland, Baltimore

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Allograft/Xenograft

    Device

    Alveolar ridge preservation of a single extraction socket site with a mixture of demineralized cortical bone substitute vallos®" and xenograft Bio-Oss®.

  • Allograft

    Device

    Alveolar ridge preservation of a single extraction socket site with vallos® (mineralized cortico-cancellous bone substitute)

Treatment groups

24 Participants
are divided into 2 treatment groups
Group A: Alveolar ridge preservation with Allograft/Xenograft groupExperimental treatment 1 intervention
Group B: Alveolar ridge preservation with Allograft groupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

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 outcomes

1

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

Time frame
4-5 months (Before Alveolar Ridge Preservation/ Enrollment [Visit 2] to 4-month follow-up [Visit 7])
2

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

Time frame
5 months (At the time of implant placement [Visit 8])

Other outcomes

Sponsors and contacts

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