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
Zusammenfassung der Studie
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)
Untersuchte Intervention
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)
Untersuchte Krankheit(en)
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)
Ausschlusskriterien
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)
Studienstandort
Bern, Zürich
(BASEC)
Sponsor
Danielle Giroud MD Clinicals SA
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
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)
Wissenschaftliche Auskünfte
nicht verfügbar
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
23.02.2024
(BASEC)
ICTRP Studien-ID
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Offizieller Titel (Genehmigt von der Ethikkommission)
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)
Wissenschaftlicher Titel
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Untersuchte Krankheit(en)
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Untersuchte Intervention
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Ein-/Ausschlusskriterien
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Primäre und sekundäre Endpunkte
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Ergebnisse der Studie
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