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

• ClinicalTrials.gov Identifier: NCT04121364
• Recruitment Status: Recruiting
• First Posted: October 9, 2019
• Last Update Posted: October 11, 2019
• Sponsor: LaunchPad Medical
• Information provided by (Responsible Party): LaunchPad Medical

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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

Eligibility Criteria

• 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.

Contacts and Locations

Contacts

Contact: George Kay, DMD; 555 555 5555; gkay@launchpadmedical.com

Contact: Brian Hess; 555 555 5555; bhess@launchpadmedical.com

Locations

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

• Study Director: George Kay, DMD; LaunchPad Medical

More Information

• Responsible Party: LaunchPad Medical
• ClinicalTrials.gov Identifier: NCT04121364
• Other Study ID Numbers: DVAL18041
• First Posted: October 9, 2019
• Last Update Posted: October 11, 2019
• Last Verified: October 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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