Adhesive Dental Clinical Trial
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
Verified date | August 2023 |
Source | RevBio |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | February 27, 2023 |
Est. primary completion date | March 10, 2022 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 21 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | University of Texas Health Science Center - San Antonio | San Antonio | Texas |
Lead Sponsor | Collaborator |
---|---|
RevBio |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Implant Success (Modified Buser Criteria) | The primary endpoint is a composite measure of implant success (after criteria of Buser, et. al.1) at six-month post-functional loading consisting of: Presence of the implant at its site of implantation; and, Absence of a recurrent peri-implant infection with suppuration; and, Absence of mobility, defined as: Lack of implant rotation subjected to 20 Ncm of clockwise torque applied 15 minutes after implant placement; and. Lack of implant rotation subjected to 35 Ncm of clockwise torque applied 13 weeks after implant placement; and, No construct mobility upon palpation at 6 months post-functional loading; and, Absence of encapsulation defined as continuous radiolucency around the implant in a periapical radiograph. |
6 months | |
Secondary | Adverse Events (Serious, Device Related) | Incidence of Device related Serious adverse events | 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05535426 -
Feasibility Study to Assess Outcomes of Immediately Inserted and Restored Dental Implants Using pH-modified Tetranite
|
N/A |