[Trial of device that is not approved or cleared by the U.S. FDA]
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
London, United Kingdom, W1G 7JD
- Norton Implants
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
Screening 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 sites 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 ASA I or ASA II;
- Subjects who present with a sound bony housing with a visible buccal plate evident at the crest and fenestrations or dehiscences limited to <5.0mm diameter 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.
- Extraction Site Enrollment Inclusion 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 HDD > 2mm in the buccal direction between the implant surface and the labial plate at the most coronal aspect of the extraction socket.
Extraction Site Enrollment Inclusion 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 HDD > 2mm in the buccal direction between the implant surface and the labial plate at the most coronal aspect of the extraction socket.
Exclusion Criteria:
Screening Exclusion Criteria
- Subjects with a systemic disease or condition affecting a major organ system that would preclude dental implant surgery (e.g., malignant neoplasm or chemotherapy in the past 6 months, uncontrolled diabetes, major infection, Cushing's syndrome, metabolic bone disease, immunosuppression, blood dyscrasias, healing bone fracture, myocardial infarction or cerebrovascular accident within the last six months, etc.);
- Subjects with any contraindications for oral surgical procedures (e.g. scleroderma, etc.);
- Subjects with mucosal diseases (e.g. erosive lichen planus, mucous membrane pemphigoid, erythema multiforme, etc.) in the localized area around the study implant site;
- 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 receiving, or having a recent or long-term history (> 5 years) of receiving, oral anti-osteoclastic agents [e.g., bisphosphonates, Fosamax® and Prolia® (denosumab); Forsteo® (teriparatide), strontium ranelate, etc.], or anti-angiogenesis factors;
- Subjects receiving or having a recent history of receiving (within 1 year) intravenous anti-osteoclastic agents (e.g. Ibandronate, Boniva®; Zoledronate, Zometa®).
- 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.
Extraction Site Enrollment Exclusion Criteria
- 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;
- Any implant site in which placement of the selected implant leaves an HDD greater than 5mm in any direction between the implant surface and the most coronal aspect of the osteotomy;
- Any site which provides primary implant stability after seating as demonstrated by insertion torque of greater than or equal to 15Ncm;
- Any implant site where, during the osteotomy preparation, a submarginal perforation develops
Study Plan
How is the study designed?
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: Tetranite Stabilized Dental Implants with Provisional Crown
Extraction of maxillary anterior teeth followed by immediate insertion and stabilization of dental implants with Tetranite in otherwise non-stable sites.
A provisional crown will also be inserted during this surgery.
|
Dental adhesive for increased implant stabilization
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What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Implant Stabilization by Resonance Frequency Analysis
Time Frame: 12-month
|
The primary endpoint is sufficient bone-to-implant interfacial stiffness post-placement of the implant stabilized by TN-SM, whereby, sufficient bone-to-implant interfacial stiffness is measured by Resonance Frequency Analysis (RFA) expressed as mean Implant Stability Quotient (ISQ, 0-100 scale, where higher is better) at 1-year post TN-SM device and implant placement.
For the study to be considered successful, the lower bound of the one-sided 97.5% confidence interval for the mean ISQ should exceed the clinical threshold of 60.
|
12-month
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Implant Stabilization by Resonance Frequency Analysis
Time Frame: 15 minutes, 3 months, and 7 months
|
Sufficient bone-to-implant interfacial stiffness measured by Resonance Frequency Analysis (RFA) expressed as Implant Stability Quotient (ISQ, 0-100 scale, where higher ISQ is better) at 15 minutes, 1 week, 1 month, 3 months, and 7 months post-implant placement.
For each timepoint to be considered successful, the lower bound of the one-sided 97.5% confidence interval for the mean ISQ should exceed the clinical threshold of 60;
|
15 minutes, 3 months, and 7 months
|
|
Device Related Adverse Events
Time Frame: 12-month
|
Low incidence, severity and duration of device-related adverse events throughout the 12-month post-implant placement follow-up period;
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12-month
|
|
Implant Stabilization by Forward Torque Assessment
Time Frame: 15 minutes
|
Immediate implant stabilization demonstrated by no rotation of the implant subjected to forward torque of 20 Ncm at 15 minutes after application of the TN-SM;
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15 minutes
|
|
Implant Success (Composite Measure)
Time Frame: 12-month
|
Composite measure of implant success throughout the 12-month post-loading follow-up period consisting of:
|
12-month
|
|
Bone Level Maintenance
Time Frame: 12-month
|
Crestal bone level maintenance assessed by analysis of two-dimensional periapical radiographic records showing no more than a 1.0mm loss of height throughout the 12-month post-loading follow-up period;
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12-month
|
|
Volume Loss
Time Frame: 12-month
|
Dimensional changes in bone volume will be evaluated: before tooth extraction, and through the 12-month post-loading follow-up period.
CBCT data will be used to perform these assessments; Peri-implant tissue health demonstrated by direct measurement around the implant at 12 months after placement of the implant as compared to existing conditions in the oral cavity near adjacent teeth to the implant site and to baseline around the implant at 3 months post placement
|
12-month
|
|
Patient Satisfaction
Time Frame: 12-month
|
Subject satisfaction using the VAS scale (0-100) for pain where 0 is no pain, esthetic outcome and function.
|
12-month
|
Collaborators and Investigators
Sponsor
Sponsor
Collaborators
Collaborators
Investigators
Investigators
- Study Chair: Grayson Allen, MBA, RevBio
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Start
Primary Completion
Primary Completion
Study Completion
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
Other Study ID Numbers
- DVAL19033
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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