Ridge Preservation With Moldable Beta-tricalcium Phosphate Bone Substitute on Non-containable Non-Molar Extraction Sites
NCT ID: NCT03215667
Last Updated: 2021-01-25
Study Results
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View full resultsBasic Information
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TERMINATED
NA
9 participants
INTERVENTIONAL
2017-08-01
2019-11-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Device treatment
easy-graft CLASSIC (beta-Tricalcium Phosphate) grafting covered with polylactide membrane
easy-graft CLASSIC (beta-Tricalcium Phosphate)
easy-graft will be grafted to a single extraction socket and covered by polylactide membrane to facilitate regeneration of new bone in order to preserve alveolar ridge dimensions.
Interventions
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easy-graft CLASSIC (beta-Tricalcium Phosphate)
easy-graft will be grafted to a single extraction socket and covered by polylactide membrane to facilitate regeneration of new bone in order to preserve alveolar ridge dimensions.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* minimum of 10-mm vertical bone without impinging on adjacent vital structures (Maxillary sinus, neurovascular bundles)
* single-rooted tooth to be extracted
* American Society of Anesthesiologists (ASA) Physical Status Classification I or II
* age \>18 years old
* subjects who had \>50% of height on any portion on the buccal wall of dehiscence and/or fenestration of the extraction socket following extraction will be included from this study
* adjacent teeth to extraction site will be present during healing period
* willingly sign informed consent and authorization.
* pregnancy or nursing woman
* subjects with active systemic or localized infection (exclude chronic periodontitis)
* subjects with a history of any medical conditions that contraindicated or weighed against dental implant placement such as history of bisphosphonate drug use, chemotherapeutic or immunosuppressive agents, autoimmune disease, or poorly controlled diabetes (HBA1c\>7%)
* subjects with smoking habit (more than 10 cigarettes per day)
18 Years
ALL
No
Sponsors
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Sunstar Americas
INDUSTRY
Responsible Party
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Locations
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Indiana University School of Dentistry
Indianapolis, Indiana, 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-2016-11-07-1
Identifier Type: -
Identifier Source: org_study_id
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