Assessment of Ridge Preservation Using Moldable Beta-tricalcium Phosphate Bone Grafting System
NCT ID: NCT02702609
Last Updated: 2020-10-22
Study Results
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View full resultsBasic Information
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COMPLETED
NA
45 participants
INTERVENTIONAL
2016-08-02
2019-08-19
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Moldable beta-TCP grafting system
Device: easy-graft CLASSIC (beta-Tricalcium Phosphate)
easy-graft CLASSIC
easy-graft will be grafted to a single extraction socket to preserve the ridge dimension for future implant placement.
Allograft
Device: Freeze-Dried Bone Allograft (FDBA) with collagen plug
FDBA with collagen plug
FDBA will be grafted to a single extraction socket and covered by collagen plug to preserve the ridge dimension for future implant placement.
Interventions
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easy-graft CLASSIC
easy-graft will be grafted to a single extraction socket to preserve the ridge dimension for future implant placement.
FDBA with collagen plug
FDBA will be grafted to a single extraction socket and covered by collagen plug to preserve the ridge dimension for future implant placement.
Eligibility Criteria
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Inclusion Criteria
* At least 18 years old
* In need of one posterior tooth, excluding third molar molars, planned for extraction and replacement with a dental implant (If the subject requires two adjacent socket preservation, they can still be enrolled in the study but only one site will be used for the study)
* Intact ridge as verified with cone-beam CT scan
* At least one natural tooth adjacent to the study site present.
Exclusion Criteria
* Dehiscence or fenestration identified at the time of reviewing CBCT.
* Non-treated caries or uncontrolled periodontal disease present affecting the teeth in adjacent to study teeth.
* Any of natural teeth adjacent to the study site presents active periapical endodontic lesion ("active periapical endodontic lesion" will be determined per consultation by endodontics specialist).
* Adjacent tooth (mesial and distal) to study site was extracted within last 6 months
* Adjacent teeth (or tooth) to study site with significant soft tissue loss
* Smoker using more than 10 cigarettes or equivalent per day
* Smokeless tobacco use or e-cigarette use
* Current alcohol or drug abuser
* Systemic or local disease or condition that would compromise post-operative healing and/or osseointegration e.g. uncontrolled diabetes
* Need for systemic corticosteroids or any other medication that would influence post-operative healing and/or osseointegration
* Pregnancy, as indicated by positive serum human chorionic gonadotropin (HCG) test result.
* Unable or unwilling to return for follow-up visits for a period of 5 months
* Unlikely to be able to comply with study procedures according to Investigators judgement
* Subject in other clinical trials
18 Years
ALL
No
Sponsors
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Sunstar Americas
INDUSTRY
Responsible Party
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Locations
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The University of Iowa College of Dentistry
Iowa City, Iowa, United States
University of Maryland School of Dentistry
Baltimore, Maryland, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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CLP-2015-12-17-1
Identifier Type: -
Identifier Source: org_study_id
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