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: Active, not recruiting
• First Posted: October 9, 2019
• Last Update Posted: September 29, 2020
• 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)
• Actual Enrollment: 20 participants
• Allocation: N/A
• 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: March 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

Locations

United States, Florida

Pikos Institute

Trinity, Florida, United States, 34655

United States, Texas

University of Texas Health Science Center - San Antonio

San Antonio, Texas, United States, 78229

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: September 29, 2020
• Last Verified: September 2020

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