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
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ClinicalTrials.gov Identifier: NCT04121364 |
Recruitment Status :
Active, not recruiting
First Posted : October 9, 2019
Last Update Posted : September 29, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Adhesive Dental | Device: Tetranite | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Intervention Model Description: | Non randomized, single arm, objective performance criteria study |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
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 |
Actual Study Start Date : | September 27, 2019 |
Estimated Primary Completion Date : | March 27, 2021 |
Estimated Study Completion Date : | November 27, 2021 |
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.
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Device: Tetranite
Dental Adhesive for increased implant stability |
- Number of patients with appropriate functional loading after crown Placement [ Time Frame: 6 months ]Torque will be applied to the Implant. If the implant does not rotate the implant will be considered a success.
- Adverse Events (Serious, Device Related) [ Time Frame: 12 months ]Incidence of Device related Serious adverse events

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Ages Eligible for Study: | 21 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04121364
United States, Florida | |
Pikos Institute | |
Trinity, Florida, United States, 34655 | |
United States, Texas | |
University of Texas Health Science Center - San Antonio | |
San Antonio, Texas, United States, 78229 |
Study Director: | George Kay, DMD | LaunchPad Medical |
Responsible Party: | LaunchPad Medical |
ClinicalTrials.gov Identifier: | NCT04121364 |
Other Study ID Numbers: |
DVAL18041 |
First Posted: | October 9, 2019 Key Record Dates |
Last Update Posted: | September 29, 2020 |
Last Verified: | September 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | Yes |
Device Product Not Approved or Cleared by U.S. FDA: | Yes |