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

NCT04121364 | Completed Results

• 1 other identifier: DVAL18041
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Adhesive Dental

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Adverse Events (Serious, Device Related)

  12 months

Study Arms (1)

Tetranite

EXPERIMENTAL

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

Interventions

Tetranite DEVICE

Dental Adhesive for increased implant stability

Tetranite

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed Informed Consent;
• + 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• RevBio: lead

Study Sites (1)

University of Texas Health Science Center - San Antonio

San Antonio, Texas, 78229, United States

Location

Results Point of Contact

• Title: Dr. Alan Pollack
• Organization: RevBio

apollack@revbio.com

9145226972

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Non randomized, single arm, objective performance criteria study

Study Record Dates

• First Submitted: October 8, 2019
• First Posted: October 9, 2019
• Study Start: September 27, 2019
• Primary Completion: March 10, 2022
• Study Completion: February 27, 2023
• Last Updated: February 21, 2024
• Results First Posted: February 21, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)