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N/A Completed N=20 Treatment

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

Adhesive Dental
Source: ClinicalTrials.gov NCT04121364 ↗
Enrolled (actual)
20
Serious AEs
65.0%
Results posted
Feb 2024
Primary outcomePrimary: Implant Success (Modified Buser Criteria) — 6 participants

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.

Outcome Measures

OutcomeResultp-value
PRIMARY
Implant Success (Modified Buser Criteria)
6
SECONDARY
Adverse Events (Serious, Device Related)

Eligibility Criteria

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.
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04121364). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.

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