Clinical trial NCT05535426: Feasibility Study to Assess Outcomes of Immediately Inserted and Restored Dental Implants Using pH-modified Tetranite
Official title: A Prospective Human Clinical Study to Assess Primary Stability and Change in Stability by Resonance Frequency Analysis of Immediately Inserted and Restored Dental Implants Using pH-Modified Tetranite® Implant Stabilization Material
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Adhesive Dental
Keywords: dental implant
stabilization
resonance frequency analysis (RFA)
bone adhesive
implant success
bone height
primary stability
Lead sponsor: RevBio
Sponsor class: INDUSTRY
First posted: 2022-09-10
Enrollment: 15
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm, objective performance criteria study
Primary purpose: TREATMENT

Brief summary: The aim of this Pilot Study is to demonstrate the safety and efficacy of the use of Tetranite Implant Stabilization Material (TN-ISM) in delivering enhanced stability to immediately restored dental implants inserted into fresh extraction sockets, with both clinical and patient-related successful outcomes.

Detailed description: The purpose of the present study is to evaluate the safety and efficacy of a single stage approach using Tetranite Implant Stabilization Material (TN-ISM). The purpose of the efficacy component of this study is a composite comprising: (1) First - To demonstrate and evaluate the ability of TN-ISM to achieve immediate implant stabilization in sites otherwise unable to provide primary stability without requiring the delay in treatment imposed by the current multi-staged standard-of-care method; (2) Second - To demonstrate and evaluate the ability of TN-ISM to achieve increasing short-term stabilization of implants as the device undergoes initial resorption and replacement with new bone; (3) Third - To demonstrate the ability of TN-ISM to aid in the maintenance of alveolar ridge contours without buccal plate collapse and loss of crestal bone height; and Fourth (4) - To demonstrate and evaluate the ability of a TN-ISM stabilized implant to achieve implant success (after criteria of Buser, et. al 1) after 12 months in situ while the device undergoes significant resorption, facilitates osteoconduction, and replacement with new bone. In addition to the Primary Endpoints of establishing the Safety and Efficacy of Implant Stabilization and Implant Success throughout the initial 12 months of post-implant and device placement, the study also assesses several secondary endpoints over the course of the study and one-year follow-up, as outlined in the sections below. These include assessment of incidence, duration, and severity of adverse effects and events; assessment of increasing implant stiffness; assessment of bone levels, bone volumetric changes; patient satisfaction surveys, and assessment of periodontal and peri-implant health integral to implant success.

Eligibility criteria: Inclusion Criteria:

* Subjects must have voluntarily signed the informed consent form before any study related procedures;
* Subjects must be males or females who are a minimum of 20 years of age;
* Subjects who require a single anterior maxillary tooth extraction and desire a replacement with a dental implant and immediate temporary crown. Candidate subjects may require more than one extraction, and all sitesbut only one site will be considered for inclusion in the study;
* Subjects must have opposing dentition (natural teeth, fixed or removable restorations);
* Subjects must be committed to the study and the required follow-up visits;
* Subjects must be American Society of Anesthesiology Grade (ASA) I or ASA II;
* Subjects who present with a sound bony housing with a visible buccal plate evident at the crest and fenestrations limited to \<5.0mm diameter on a cone beam CT;
* Subjects who present with a sound bony housing with a visible buccal plate evident at the crest and dehiscences limited to \<3.0mm in any direction on a cone beam CT;
* There must be sufficient bone height crestal to critical anatomical structures, i.e., the piriform foramen, and maxillary sinus, to safely place a dental implant within the bone contours. Extraction sockets should be able to accommodate an implant ≥9.0mm in length;
* Anatomical conditions must be present to allow an implant crown restoration to be placed at the candidate site, e.g., sufficient interocclusal space, incisal Class1 or Class 2 Div 1 relation, appropriate angulation of the ridge, etc.

Exclusion Criteria:

* There is at least 2mm of apical bone below the apex of the extraction socket for positive seating of the implant;
* Any implant site in which placement of the selected implant leaves an (Horizontal Dimension of Defect) HDD \> 2mm in the buccal direction between the implant surface and the labial plate at the most coronal aspect of the extraction socket.

Primary outcomes:
measure: Implant Stabilization by Resonance Frequency Analysis
timeFrame: 12 months
Secondary outcomes:
measure: Implant Stabilization by Resonance Frequency Analysis
timeFrame: 15 minutes, 3 months, and 7 months
measure: Device Related Adverse Events
timeFrame: 12 months
measure: Implant Stabilization by Manual Palpation
timeFrame: 15 minutes, 1 month, 3 months, and 7 months
measure: Implant Success (Composite Measure)
timeFrame: 12 months
measure: Volume Loss
timeFrame: 12 months
measure: Per-implant tissue health
timeFrame: 12 months
measure: Patient Satisfaction
timeFrame: 12 months
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Norton Implants
Study officials:
References:
citation: Cochran DL, Jones A, Sugita R, Brown MC, Guda T, Prasad H, Ong JL, Pollack A, Kay GW. Immediate Dental Implant Stabilization in a Canine Model Using a Novel Mineral-Organic Adhesive: 4-Month Results. Int J Oral Maxillofac Implants. 2020 Jan/Feb;35(1):39-51. doi: 10.11607/jomi.7891.