Immediate placement and stabilization of dental implants with the Tetranite® implant stabilization material at extraction sites for lower and upper jaw teeth that do not provide sufficient primary stability
Summary description of the study
After tooth loss, replacement with an implant is currently one of the best therapeutic options. The implant relies on a sufficient quantity and quality of jawbone. Immediate implants significantly shorten treatment duration and lead to higher patient satisfaction, while maintaining a high success rate. However, sometimes an immediate implant cannot be placed because sufficient stability in the bone cannot be found. This study tests a novel material, Tetranite® Dental Bone Adhesive - implant stabilization material, to effectively "glue" the implant in place and thereby increase its initial stability. This material has proven to be safe in preclinical studies and can very effectively improve the initial stability of the dental implant without damaging the bone. The material consists of an organic calcium phosphate and an amino acid, phosphoserine, which occurs naturally in bone. It is completely synthetic. The use of the adhesive extends the total time of the procedure by just over 15 minutes. After the healing of the implant, the patient receives an implant crown. The implants are clinically and radiologically followed up after three, six, and 12 months.
(BASEC)
Intervention under investigation
After the gentle removal of the tooth to be extracted, a titanium implant is inserted. Then, the remaining "hole" where the tooth was is filled with the Tetranite material to provide the implant with sufficient stability. After the healing of the implant, the patient receives an implant crown. The implants are clinically and radiologically followed up after three, six, and 12 months.
(BASEC)
Disease under investigation
This study investigates how a novel material behaves that is used for stabilizing the implant in the event of tooth loss and immediate replacement with an "immediate implant".
(BASEC)
1. Patients who need to have a tooth removed and wish to replace it with an implant. 2. Anatomical conditions must allow for implantation. 3. Immediate implants that are not stable in the bone alone. (BASEC)
Exclusion criteria
1. Patients with general medical conditions or untreated conditions in the oral area. 2. Patients with anatomical conditions that do not allow for implantation or immediate implantation. 3. Patients taking medications or substances that could influence the therapy. (BASEC)
Trial sites
Bern, Zurich
(BASEC)
Sponsor
Danielle Giroud MD Clinicals SA
(BASEC)
Contact
Contact Person Switzerland
Prof. Patrick Schmidlin
+41 44 634 34 17
patrick.schmidlin@clutterzzm.uzh.chCenter of Dental Medicine, University of Zürich Clinic of Preventive Dentistry, Periodontology and Cariology Plattenstrasse 11 8032 Zürich patrick.schmidlin@zzm.uzh.ch
(BASEC)
Scientific Information
not available
Name of the authorising ethics committee (for multicentre studies, only the lead committee)
Ethics Committee Zurich
(BASEC)
Date of authorisation
23.02.2024
(BASEC)
ICTRP Trial ID
not available
Official title (approved by ethics committee)
Immediate Placement and Stabilization of Dental Implants with Tetranite® Implant Stabilization Material in Mandibular and Maxillary Tooth Extraction Sites that Fail to Provide Adequate Primary Stability (BASEC)
Academic title
not available
Public title
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Disease under investigation
not available
Intervention under investigation
not available
Type of trial
not available
Trial design
not available
Inclusion/Exclusion criteria
not available
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Primary and secondary end points
not available
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Registration date
not available
Incorporation of the first participant
not available
Secondary sponsors
not available
Additional contacts
not available
Secondary trial IDs
not available
Results-Individual Participant Data (IPD)
not available
Further information on the trial
not available
Results of the trial
Results summary
not available
Link to the results in the primary register
not available