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[Trial of device that is not approved or cleared by the U.S. FDA]

Primary Purpose

Status
Withheld
Phase
Locations
Intervention
Sponsored by
[Redacted]
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an trial

Eligibility Criteria

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Inclusion Criteria:

  • Signed Informed Consent;
  • 21+ Age;
  • Require tooth extraction and replacement with dental implant;
  • Have opposing dentition;
  • Committed to Study and Follow-up period;
  • ASA I or II;
  • Planned "implant site" must have 1 adjacent tooth;
  • Sufficient bone Height for safe dental implant placement;
  • At least 2 mm of apical bone for seating of implant.

Exclusion Criteria:

  • Any significant disease that would preclude a dental implant
  • Any oral surgery contraindications
  • Subjects with mucosal Disease
  • Subjects with bone diseases or conditions (e.g. Paget's disease, fibrous dysplasia, history of osteomyelitis, etc.) in the region of the potential study implant site;
  • Subjects with a history of local radiation therapy in the head/neck area or osteonecrosis of the jaws;
  • Subjects with any acute and untreated endodontic lesions or periodontal disease;
  • Subjects receiving, or having a recent or long-term history of receiving, oral or parenteral anti-osteoclastic agents [e.g., bisphosphonates, Xgeva® and Prolia® (denosumab); Forteo® (teriparatide), strontium ranelate, etc.], or anti-angiogenesis factors;
  • Subjects who have major active substance abuse problems (e.g., alcoholism, opiate addiction, methamphetamine abuse, etc.);
  • Subjects who are pregnant or intending to become pregnant during the duration of the study;
  • Subjects who are heavy smokers (defined as >10 cigarettes per day or >1 cigar per day or equivalent of electronic cigarette vaping) or chew tobacco;
  • Subjects with inadequate oral hygiene or who are unmotivated for adequate home care;
  • Subjects who have physical or mental handicaps that would interfere with the ability to perform adequate oral hygiene;
  • Subjects who have undergone administration of any investigational device within 30 days of enrollment in the study;
  • Subjects who are allergic or otherwise sensitive to any materials likely encountered during the course of the study (e.g. titanium, suture materials, local anesthetics);
  • Subjects with conditions or circumstances, which, in the opinion of the Investigator, would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance or unreliability
  • Any site into which the implant is not or cannot be placed during the same visit as the extraction;
  • Any implant site where there is a dehiscence or fenestration of buccal or lingual plates of bone greater than 5mm in any direction.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    Secondary Outcome Measures

    Full Information

    First Posted
    October 8, 2019
    Last Updated
    August 7, 2023
    Sponsor
    [Redacted]
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    1. Study Identification

    Unique Protocol Identification Number
    NCT04121364
    Brief Title
    [Trial of device that is not approved or cleared by the U.S. FDA]
    Official Title
    [Trial of device that is not approved or cleared by the U.S. FDA]

    2. Study Status

    Overall Recruitment Status
    Withheld
    Study Start Date
    undefined (undefined)
    Primary Completion Date
    undefined (undefined)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Name of the Sponsor
    [Redacted]

    4. Oversight

    5. Study Description

    6. Conditions and Keywords

    7. Study Design

    10. Eligibility

    12. IPD Sharing Statement

    Learn more about this trial

    [Trial of device that is not approved or cleared by the U.S. FDA]

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