Evaluation of a one-piece ceramic implant used for single tooth replacement and three-unit bridge restoration. A cohort clinical trial

Zentrum für ZahnmedizinKlinik für Kronen- und Brückenprothetik, Teilprothetik und zahnärztliche Materialkunde0 sites60 target enrollmentOctober 1, 2009

ConditionsK08.1 Loss of teeth due to accident, extraction or local periodontal disease

Overview

Phase: 未知
Intervention: Not specified
Conditions: K08.1
Sponsor: Zentrum für ZahnmedizinKlinik für Kronen- und Brückenprothetik, Teilprothetik und zahnärztliche Materialkunde
Enrollment: 60
Status: Completed
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 1, 2009

End Date

April 24, 2017

Last Updated

last year

Study Type

Interventional

Sex

All

Investigators

Sponsor

Zentrum für ZahnmedizinKlinik für Kronen- und Brückenprothetik, Teilprothetik und zahnärztliche Materialkunde

Eligibility Criteria

Inclusion Criteria

•1\. Ability to understand the nature of the study and the study related procedures.
•2\. Written informed consent obtained according to international guidelines and local law.
•3\. The subjects must be in the age of 18 to 70 years old.
•4\. The subject must be systemically healthy and have good compliance.
•5\. The subject must be in need of an implant supported partial denture or implant supported single tooth restorations.
•6\. The subjects must have sufficient bone volume and density i.e. an osseous architecture in the implant placement region enough to receive implants of 4\.0 mm in diameter and a sufficient amount of bone for placing implants with a length of at least 8 mm.
•7\. The osseous architecture must be such that it is possible to obtain primary implant stability, i.e. final tightening torque of 35\-45 Ncm.
•8\. The subject must have a stable occlusal relationship with no pronounced bruxism.
•9\. The implant sites must be free from infection and/or extraction remnants

Exclusion Criteria

•1\. Alcohol or drug abuse as noted in patient records or in patient history.
•2\. Smoking
•3\. Health conditions, which do not permit the surgical procedure (see section D5\).
•4\. Reason to believe that the treatment might have a negative effect on the subject?s total situation (psychiatric problems), as noted in patient records or in patient history.
•5\. The patient has infectious disease, heart disease or disease of the circulatory system, metabolic disease, bone metabolism disorders, disturbance of the hematopoetic system, hematological disorders, wound healing disturbances, disorders of the endocrine system (i.e., uncontrolled diabetes), local (i.e., tumors, ulcers etc) or other contraindications for dental surgery as noted in patient records or in patient history. A female participant is pregnant.
•6\. The subject is not able to give her/his informed consent to participate.
•7\. The need of bone augmentation (e.g. sinus augmentation procedure) before implant installation to obtain a prosthetically correct implantation transversally. However, a minor augmentation procedure to cover exposed threads or interproximal/buccal grafting due to deficient sites is not an exclusion criteria.
•8\. Any disorders in the planned implant area such as previous tumors, chronic bone disease, or previous irradiation.
•9\. Severe bruxism or other destructive habits.
•10\. Immediate insertion (e.g. placement of the implant immediately after extraction)