Evaluation of the clinical safety and performance of a narrow diameter (2.9 mm) bone-level implant: a 1-year prospective single-arm multicenter study.
Adverse device events
Bone-level tapered
Implant success
Implant survival
Marginal bone-level change
Narrow-diameter implant
PES
Prospective study
Roxolid®
Journal
International journal of implant dentistry
ISSN: 2198-4034
Titre abrégé: Int J Implant Dent
Pays: Germany
ID NLM: 101676532
Informations de publication
Date de publication:
19 09 2023
19 09 2023
Historique:
received:
13
04
2023
accepted:
29
08
2023
medline:
21
9
2023
pubmed:
19
9
2023
entrez:
19
9
2023
Statut:
epublish
Résumé
Narrow-diameter implants facilitate single-tooth restoration when interdental or inter-implant spaces and bone volume are inadequate for using standard diameter implants. This study reports the short-term data on the clinical safety and performance of a bone-level-tapered two-piece implant with a 2.9 mm diameter in the clinical practice setting. This study was retrospectively registered on March 1st, 2016 (NCT02699866). Implants were placed in partially healed extraction sockets of the central and lateral incisors in the mandible and lateral incisors in the maxilla for single-tooth replacement. The primary outcome was to assess implant survival at 12 months after placement. Secondary outcomes included implant success, pink esthetic score, marginal bone-level changes, and safety. Twenty four males and 17 females with a mean age of 44.5 (± 18.3 standard deviation) received the implant. Three out of 41 implants were lost yielding a survival rate of 92.7% (95%-CI: 79.0%; 97.6%) at 1 year. One patient reported an ongoing foreign body sensation, pain, and/or dysesthesia at month 12. The average pink esthetic score at 6 months was 11.2 (95%-CI: 10.5; 11.9). The bone level was stable with a mean bone-level change of-0.3 mm (± 0.42 mm standard deviation) at 1 year after implantation. No serious adverse events or adverse device events were reported. The use of a 2.9 mm diameter bone-level-tapered implant is a safe and reliable treatment option for narrow tooth gaps at the indicated locations. Overall performance and good survival rates support their use in cases, where wider implants are unsuitable.
Identifiants
pubmed: 37725234
doi: 10.1186/s40729-023-00495-x
pii: 10.1186/s40729-023-00495-x
pmc: PMC10509112
doi:
Substances chimiques
Dental Implants
0
Banques de données
ClinicalTrials.gov
['NCT02699866']
Types de publication
Multicenter Study
Journal Article
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
32Informations de copyright
© 2023. Deutsche Gesellschaft für Implantologie im Zahn‐, Mund‐ und Kieferbereich e.V., Japanese Society of Oral Implantology.
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