Adhesive DentalNCT04121364
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
A study testing Tetranite in people with Adhesive Dental, run by RevBio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Adhesive Dental
- What is being tested?
- Tetranite
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2019to 27 Feb 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas Health Science Center - San Antonio
San Antonio, Texas, 78229
About this study
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
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.
Read the 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.
- Conditions
- Adhesive Dental
- Being tested
- Tetranite
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TetraniteDevice
Dental Adhesive for increased implant stability
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Tetranite |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
Adverse Events (Serious, Device Related)
Incidence of Device related Serious adverse events
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study start27 Sep 2019
- Primary completion10 Mar 2022
- Study completion27 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adhesive DentalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Non randomized, single arm, objective performance criteria study
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- RevBio
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04121364
- Sponsor's protocol ID
- DVAL18041
- Status last verified
- Aug 2023
- First submitted
- 8 Oct 2019
- Last updated
- 21 Feb 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04121364
- Acronym / sponsor ID
- DVAL18041
- Conditions
- Adhesive Dental
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- RevBioIndustry (pharma, biotech, devices)
- Study start
- 27 Sep 2019 (actual)
- Primary completion
- 10 Mar 2022 (actual)
- Study completion
- 27 Feb 2023 (actual)
- First posted
- 9 Oct 2019 (actual)
- Results
- Posted 21 Feb 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Non randomized, single arm, objective performance criteria study
| Arm | Type | Receives |
|---|---|---|
| Tetranite | Experimental | Device: TetraniteAll 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Signed Informed Consent;
- 21+ Age;
- Require tooth extraction and replacement with dental implant;
- Have opposing dentition;
- Committed to Study and Follow-up period;
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TetraniteDental Adhesive for increased implant stability | Device | Tetranite |
Primary outcome
Implant Success (Modified Buser Criteria)
Time frame: 6 months
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.
1 secondary outcome
Adverse Events (Serious, Device Related)
Time frame: 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tetranite in people with Adhesive Dental, run by RevBio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Feb 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant Success (Modified Buser Criteria) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Feb 2024.