Clinical trial NCT04121364: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Conditions: Adhesive Dental
Lead sponsor: RevBio
Sponsor class: INDUSTRY
First posted: 2019-10-09
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Non randomized, single arm, objective performance criteria study
Primary purpose: TREATMENT

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.

Detailed description: This is a prospective, multi-center, single arm, pilot clinical study evaluating the use of TN-SM for implant stabilization immediately after tooth extraction. The purpose of this pilot study is to test performance characteristics and capabilities of study design, recruitment criteria, procedures, measures, and operational strategies that are under consideration for use in a subsequent, larger clinical pivotal study. The purpose of the subsequent study will be to provide data demonstrating the safety and efficacy for the use of TN-SM to provide immediate and continued stabilization of implants placed into otherwise unstable sites. Use of TN-SM eliminates the need for the standard practice of bone grafting after tooth extraction and staged implant placement, significantly shortening the overall length of this treatment.

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.

Primary outcomes:
measure: Implant Success (Modified Buser Criteria)
timeFrame: 6 months
Secondary outcomes:
measure: Adverse Events (Serious, Device Related)
timeFrame: 12 months
Other outcomes:
Locations:
city: San Antonio
country: United States
facility: University of Texas Health Science Center - San Antonio
state: Texas
Study officials:
References: