[Trial of device that is not approved or cleared by the U.S. FDA]
Primary Purpose
Status
Withheld
Phase
Locations
Intervention
Sponsored by
![[Redacted]](https://trials-media.s3.amazonaws.com/orgs/redacted.jpeg)
About this trial
This is an trial
Eligibility Criteria
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
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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