Status:
COMPLETED
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
Lead Sponsor:
RevBio
Conditions:
Adhesive Dental
Eligibility:
All Genders
21+ years
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 te...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 27 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 27 2023
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT04121364
Start Date
September 27 2019
End Date
February 27 2023
Last Update
February 21 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
University of Texas Health Science Center - San Antonio
San Antonio, Texas, United States, 78229