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

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

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.

Study Overview

• Status: Completed
• Conditions: Adhesive Dental
• Intervention / Treatment: Device: Tetranite

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • San Antonio, Texas, United States, 78229
      • University of Texas Health Science Center - San Antonio

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events (Serious, Device Related)	Incidence of Device related Serious adverse events	12 months

Collaborators and Investigators

• Sponsor: RevBio
• Investigators: Study Director: George Kay, DMD, RevBio

Study record dates

Study Major Dates

• Study Start (Actual): September 27, 2019
• Primary Completion (Actual): March 10, 2022
• Study Completion (Actual): February 27, 2023

Study Registration Dates

• First Submitted: October 8, 2019
• First Submitted That Met QC Criteria: October 8, 2019
• First Posted (Actual): October 9, 2019

Study Record Updates

• Last Update Posted (Estimated): February 21, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: DVAL18041

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes