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Immediate Placement and Stabilization of Dental Implants With Tetranite Stabilization Material in Mandibular and Maxillary Tooth Extraction Sites That Fail to Provide Adequate Primary Stability

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04121364
Recruitment Status : Recruiting
First Posted : October 9, 2019
Last Update Posted : October 11, 2019
Sponsor:
Information provided by (Responsible Party):
LaunchPad Medical

Brief Summary:
This study is to determine if a new bone adhesive is useful in stabilizing dental tooth implants. Data collected from the study will examine the strength, performance, and the safety of the material.

Condition or disease Intervention/treatment Phase
Adhesive Dental Device: Tetranite Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Non randomized, single arm, objective performance criteria study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Immediate Placement and Stabilization of Dental Implants With Tetranite® Stabilization Material in Mandibular and Maxillary Tooth Extraction Sites That Fail to Provide Adequate Primary Stability
Actual Study Start Date : September 27, 2019
Estimated Primary Completion Date : September 27, 2021
Estimated Study Completion Date : November 27, 2021

Arm Intervention/treatment
Experimental: Tetranite
All patients enrolled in study will receive the dental adhesive with a dental implant. The robustness of the dental implant stability will be assessed at various time points.
Device: Tetranite
Dental Adhesive for increased implant stability




Primary Outcome Measures :
  1. Number of patients with appropriate functional loading after crown Placement [ Time Frame: 6 months ]
    Torque will be applied to the Implant. If the implant does not rotate the implant will be considered a success.


Secondary Outcome Measures :
  1. Adverse Events (Serious, Device Related) [ Time Frame: 12 months ]
    Incidence of Device related Serious adverse events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04121364


Contacts
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Contact: George Kay, DMD 555 555 5555 gkay@launchpadmedical.com
Contact: Brian Hess 555 555 5555 bhess@launchpadmedical.com

Locations
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United States, Florida
Pikos Institute Recruiting
Trinity, Florida, United States, 34655
Contact: Michael Pikos, DDS    727-781-0491    Learn@PikosInstitute.com   
Principal Investigator: Michael Pikos, DDS         
Sponsors and Collaborators
LaunchPad Medical
Investigators
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Study Director: George Kay, DMD LaunchPad Medical

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Responsible Party: LaunchPad Medical
ClinicalTrials.gov Identifier: NCT04121364    
Other Study ID Numbers: DVAL18041
First Posted: October 9, 2019    Key Record Dates
Last Update Posted: October 11, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes