Performance Evaluation of FullCeram Implants in Single Tooth Gaps
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|ClinicalTrials.gov Identifier: NCT02163395|
Recruitment Status : Active, not recruiting
First Posted : June 13, 2014
Results First Posted : July 16, 2015
Last Update Posted : December 4, 2018
- Straumann Monotype FullCeram implants serve as a suitable alternative for implant therapy especially in the aesthetic zone
- The survival rate of Straumann Ceramic implants should be at least 85% (max 6 implant losses out of 40 patients) after the first year
|Condition or disease||Intervention/treatment||Phase|
|Tooth Loss||Device: FullCeram implant||Not Applicable|
This is a prospective, open label, single arm, multicenter study. The total study duration for each patient should be 35 to 42 month including a 3-year follow-up). It is acceptable to have the visit performed up to 6 month after the aspired date.
The primary study parameter will be analyzed as soon as every patient passed visit 6 (annual follow-up visit, 12 month +/- 4 weeks).
Implants will be placed transmucosally and will be protected by a thermoplastic splint for healing. A provisional prosthesis will be placed (out of occlusion) 12-14 weeks post implant placement. The final crown will be done between study week 24 and 28. Implant survival, implant success, bone loss, periodontal parameters and adverse events will be assessed in the follow-up visits.
In total 8 visits are scheduled in this study. The investigational device: Straumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment heights of 4.0 or 5.5 mm. This is a CE marked product.
Three centres in Germany will participate. The study and any amendments will be performed as far as possible according to ISO 14155 (Second Edition, 2011-02-01) and conform to the Declaration of Helsinki (last revised Seoul 2008) and local legal and regulatory requirements.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective Open Label Single Arm Study to Evaluate the Performance of Straumann Monotype FullCeram (Zirconium Dioxide) Implants in Single Tooth Gaps in the Maxilla and Mandible|
|Study Start Date :||October 2011|
|Actual Primary Completion Date :||September 2013|
|Estimated Study Completion Date :||September 2022|
Straumann FullCeram Implant is a monotype ZrO2 implant with a diameter of 4.1 mm, available in lengths of 8, 10, 12 and 14 mm and abutment heights of 4.0 or 5.5 mm
Device: FullCeram implant
Other Name: Straumann Monotype FullCeram (Zirconium dioxide)
- The Implant Survival [ Time Frame: Measured at 12 months +/- 4 weeks after implant placement ]A surviving implant is an integrated implant in the patient's jaw bone at the time of assessment.
- The Implant Success [ Time Frame: Measured at Week 26, Month 12, Month 24 and Month 36 ]
According to Buser et al 1992 an implant will be deemed a success if all of the following success criteria apply.
- Absence of persisting subjective discomfort such as pain, foreign body perception and or dysaesthesia (painful sensation)
- Absence of a recurrent peri-implant infection with suppuration (where an infection is termed recurrent if it is observed at two or more follow-up visits after treatment with systemic antibiotics)
- Absence of implant mobility on manual palpation
- Absence of any continuous peri-implant radiolucency
- Mean Bone Level Changes (Distal and Mesial) [ Time Frame: Measured at Week 26, Month 12, Month 24 and Month 36 ]A radiographic stent was produced to have a standard measurement. The distal and mesial bone levels were combined into a single value by averaging the two values. Negative bone level changes representing bone loss between baseline and follow-up visits, vice versa positive changes representing bone gain.
- The Implant Survival [ Time Frame: Measured at Week 26, Month 24 and Month 36 ]A surviving implant is an integrated implant in the patient's jaw bone at the time of assessment.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02163395
|Medizinische Hochschule Hannover Klinik und Poliklinik fuer Mund-, Kiefer- und Gesichtschirurgie|
|Hannover, Germany, 30625|
|Private practice Theatinerstrasse 1|
|Munich, Germany, 80333|
|Stuttgart, Germany, 70174|
|Principal Investigator:||Dieter Weingart, Prof Dr Dr||Katharinenhospital|