This trial is active, not recruiting.

Condition tooth loss
Treatment fullceram implant
Sponsor Institut Straumann AG
Start date October 2011
End date September 2013
Trial size 44 participants
Trial identifier NCT02163395, CR 01/07


- 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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
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 hights of 4.0 or 5.5 mm
fullceram implant Straumann Monotype FullCeram (Zirconium dioxide)
FullCeram implantation

Primary Outcomes

The Implant Survival
time frame: Measured at 12 months +/- 4 weeks after implant placement

Secondary Outcomes

The Implant Success
time frame: Measured at 12 months +/- 4 week
Mean Bone Level (Distal and Mesial)
time frame: Measured at 12 months +/- 4 week
The Implant Survival
time frame: Measured at 26 weeks +/- 1 week
The Implant Survival
time frame: Measured at 24 months +/- 4 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Subject must have voluntary signed the informed consent and the data protection consent form before any study related action - Males and females with at least 18 years of age (including 18 years) - Implant placement planned in the maxilla or mandible - The missing tooth site must have a tooth with a natural root - Substantially healed and augmented extraction sockets (minimal 8 weeks) - Autogenous bone augmentation until 3 month pre-implantation were bone deficiency jeopardizing the implant position Exclusion Criteria: Pre-surgical exclusion criteria: - Systemic disease that would interfere with dental implant therapy - Any contraindications for oral surgical procedures - Mucosal diseases - History of local irradiation therapy - Current untreated periodontitis or gingivitis - Any untreated endodontic lesions - Probing pocket depth of > or = 4 mm on one of the teeth immediately adjacent to the dental implant site - Severe bruxing or clenching habits - Patients with inadequate oral hygiene or unmotivated for adequate home care - Patients who smoke >10 cigarettes per day or tobacco equivalents or chew tobaco - Subjects who have undergone administration of any investigational device within 30 days of enrolment in the study - Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance or unreliability - Physical or mental handicaps that would interfere with the ability to perform adequate oral hygiene - Pregnant women at screening Secondary exclusion criteria at or after implant surgery: - Lack of primary stability of the implant (hand testing directly after surgery) - Inappropriate implant position for the prosthetic requirements (to be estimated before provisional restoration) - Major simultaneous augmentation procedures (at surgery) - X-ray of implant does not show the implant from first bone contact to apical tip (at surgery)

Additional Information

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
Principal investigator Dieter Weingart, Prof Dr Dr
Description 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 srvival, 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.
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Institut Straumann AG.