Clinical Study on Zirconia Bridges
zirconia bridge restoration
Congenital Abnormalities+4
+ Stomatognathic Diseases
+ Congenital, Hereditary, and Neonatal Diseases and Abnormalities
Treatment Study
Summary
Study start date: January 1, 2010
Actual date on which the first participant was enrolled.To evaluate the clinical performance and survival rate of NobelProceraTM Bridge Shaded Zirconia on natural teeth in the posterior region for a period of 5 years. The working hypothesis of this clinical study is that industrial centrally produced 3- or 4-unit bridges of shaded yttrium-oxide partially-stabilized (Y-TZP) zirconia (NobelProceraTM Shaded Zirconia) in combination with a veneering ceramic material will show sufficient CDA ratings (80% R+S) and a sufficient survival rate (93%) after 5 years in comparison with a reference level of 95%.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.9 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Any sex
Biological sex of participants that are eligible to enroll.From 18 to 70 Years
Range of ages for which participants are eligible to join.Healthy volunteers not allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: The subject must be at least 18 (or age of consent), and less than 70 at the time of inclusion. The subject is healthy and compliant with good oral hygiene The subject is in need of a posterior fixed partial denture restoration of up to 4 units distal of the canines in the maxilla or mandible. The subject shall have a stable occlusal relationship with a fully restored, fixed opposing dentition. Obtained informed consent from the subject the subject should be available for the 5-year term of the investigation. No apical disorder or inflammation of abutment teeth, adjacent and opposing teeth. Good gingival / periodontal / periapical status of restoring, opposing and adjacent teeth. Healed situation of soft tissue augmentation is allowed. The subject should be available for the 5-year term of the investigation. Exclusion Criteria: The subject is not able to give her/his informed consent to participate. Alcohol or drug abuse as noted in patient records or in patient history. Reason to believe that the treatment might have a negative effect on the patient's total situation (psychiatric problems), as noted in patient records or in patient history. An existing condition where acceptable retention of the restoration is impossible to attain Mobility of the tooth to be restored. Pathologic pocket formation of 4 mm or greater around the tooth to be restored Severe bruxism or other destructive habits Amount of attached soft tissue is insufficient (no attached gingiva on the buccal side of the tooth). Health conditions, which do not permit the restorative procedure
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy Objectives
Primary Objectives