Clinical trial NCT02163395: Performance Evaluation of FullCeram Implants in Single Tooth Gaps
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Loss
Keywords: Ceramic implant
Lead sponsor: Institut Straumann AG
Sponsor class: INDUSTRY
First posted: 2014-06-13
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: * 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

Detailed description: This is a prospective, open label, single arm, multicenter study. The total study duration for each patient was prolonged to 10 years 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 10 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 are participating. 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.

Eligibility criteria: 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 tobacco
* 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)

Primary outcomes:
measure: The Implant Survival
timeFrame: Measured at 12 months +/- 4 weeks after implant placement
Secondary outcomes:
measure: The Implant Success
timeFrame: Measured at Week 26, Month 12, Month 24 and Month 36
measure: Mean Bone Level Changes (Distal and Mesial)
timeFrame: Measured at Week 26, Month 12, Month 24 and Month 36
measure: The Implant Survival
timeFrame: Measured at Week 26, Month 24 and Month 36
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover Klinik und Poliklinik fuer Mund-, Kiefer- und Gesichtschirurgie
city: Munich
country: Germany
facility: Oralchirurgie T1
city: Stuttgart
country: Germany
facility: Katharinenhospital
Study officials:
affiliation: Oralchirurgie T1
name: Michael Gahlert, Prof Dr Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lambrecht TJ, Filipi A, Raetzer Luenzel A, Schiel HJ. Long-Term evaluation of submerged and nonsubmerged ITI solid-screw titanium implants. A 10-year life table analysis of 468 implants. Int J Oral Maxifollofac Implants; 18:826-834, 2003. Kohal R J, et al. Loaded custom-made zirconia and titanium implants show similar osseointegration: an animal experiment. J Periodontol. 75.9, 1262-68, 2004. Scarano A, et al. Bone response to zirconia ceramic implants: an experimental study in rabbits. J Oral Implantol. 8-12, 29.1, 2003. Sennerby L, at al. Bone tissue resonses to surface-modified zirconia implants: A histomorphometric and removal torque study in the rabbit. Clin. Implant. Dent.Relat Res. 7 Suppl: S13-S20, 2005. Blaschke C, and Volz U. Soft and hard tissue response to zirconium dioxide dental implants - a clinical study in man. Neuro.Endocrinol.Lett. 27.Suppl1, 2006. Olivia J, Olivia X, Olivia JD. One year follow-up of first consecutive 100 Zirconia Dental Implants in humans: A comparison of 2 different rough surfaces. Int J Oral Maxillofac Implants; 22:430-435, 2007. Herrmann JS, Buser D, Schenk RK, Schoolfield JD, Cochran DL. Biologic width around one-and two-piece titanium implants. A histometric evaluation of unloaded nonsubmerged and submerged implants in the canine mandible. Clin Oral Impl Res 12, 559-571, 2001. Todescan FF, Pustiglioni FE, Imbronito AV, Albrektson T, Gioso M. Influenze of the microgap in the peri-implant hard and soft tissues. A histomorphometric study in dogs. Int J Pral Maxillofac Implants 17:467-472, 2002. Buser D, Weber HP, Braegger U, Balsinger C. Gewebeintegration einphasiger ITI-Implantate: Drei-Jahres-Ergebnisse einer prospektiven Langzeitstudie mit Hohlzylinder- und Hohlschraubenimplantaten. Buser D, Martin W, Belser UC. Optimizing Esthetics for Implant restorations in the Anterior Maxilla: Anatomic and Surgical Considerations. Int. J Oral and Maxillofacial Implants. Supplement; 19:43-61, 2004.
citation: Bormann KH, Gellrich NC, Kniha H, Schild S, Weingart D, Gahlert M. A prospective clinical study to evaluate the performance of zirconium dioxide dental implants in single-tooth edentulous area: 3-year follow-up. BMC Oral Health. 2018 Nov 1;18(1):181. doi: 10.1186/s12903-018-0636-x.