Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
24 participants
INTERVENTIONAL
2025-01-13
2028-06-30
Brief Summary
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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
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Alveolar ridge preservation with Allograft/Xenograft group
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 the mixture of demineralized cortical allograft vallos®f and xenograft bone substitute called Bio-Oss®.
Allograft/Xenograft
Alveolar ridge preservation of a single extraction socket site with a mixture of demineralized cortical bone substitute vallos®" and xenograft Bio-Oss®.
Alveolar ridge preservation with Allograft group
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®.
Allograft
Alveolar ridge preservation of a single extraction socket site with vallos® (mineralized cortico-cancellous bone substitute)
Interventions
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Allograft/Xenograft
Alveolar ridge preservation of a single extraction socket site with a mixture of demineralized cortical bone substitute vallos®" and xenograft Bio-Oss®.
Allograft
Alveolar ridge preservation of a single extraction socket site with vallos® (mineralized cortico-cancellous bone substitute)
Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
ALL
Yes
Sponsors
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University of Maryland, Baltimore
OTHER
Responsible Party
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Locations
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University of Maryland School of Dentistry
Baltimore, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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Hanae Saito, DDS MS CCRC
Role: primary
Other Identifiers
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SAP# 101-080
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
HP-00110704
Identifier Type: -
Identifier Source: org_study_id