One-piece zirconia implants restored with three-unit all-ceramic fixed dental prostheses on maxillary and mandibular posterior teeth. A prospective clinical multicentric study.

Not Applicable

Recruiting

Conditions: ICD-10-GM K10. 9Bone quality: 1, 2, 3 or 4 according to Lekholm & Zarb.Bone quantity: A-E according to Lekholm & Zarb.Papilla index (Jemt)Modified Plaque Index (mPI)(Mombelli et al.)Modified Sulcular Bleeding Index (mBI) (Mombelli et al.)Probing depth (PD), mmClinical attachment level (CAL), mm
K10.9
Disease of jaws, unspecified

Registration Number: DRKS00030380

Lead Sponsor: Charité Campus Benjamin Franklin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 40

Inclusion Criteria

Patients with the following planning findings are restored with implants:
- The intraoral condition of the patient shows a dentition with the need for a three-unit end abutment bridge.
- Internal sinus lift up to 2mm allowed.
- Min. implant length 8mm.
- Extraction at least 3 months ago. Only early implant placement (3 - 6 months post extraction) and late implant placement (> 6 months post extraction).
- Lateral bone augmentations are possible simultaneously during the surgical procedure.
- The patient demonstrates good oral hygiene and compliance.
- A pre-implant hygiene phase and or pa treatment must be completed.

Exclusion Criteria

- Persons under 18 or persons lacking legal capacity.
- Untreated acute periodontitis with pocket depths > 4 mm.
- Heavy smokers (more than 10 cigarettes per day).
- Taking bisphosphonates or rank ligand inhibitors (Denuso-map) or other drugs affecting bone metabolism (e.g. Cor-tison).
- Pregnant women.
- Alcohol or drug abusers.
- Patients with an infectious disease such as hepatitis or HIV or AIDS.
- Patients with severe, uncontrolled diabetes.
- Immediate implantations.
- Patients with signs of bruxism.
- Patients who require an internal sinus lift > 2 mm or an external sinus lift for implantation of a ceramic.implant CI due to bone resorption.

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Survey of the success rate of ceramic implants ceramic.implant CI.<br>The statistical evaluation of the primary endpoint peri-implant bone loss is performed after data collection (approx. 5 years) by a linear mixed model with fixed and random intercept. From this model, the two-sided 95% confidence interval is calculated for the fixed intercept. If the upper limit of this confidence interval is below the non-inferiority limit of 1.09 mm, the null hypothesis is rejected and the non-inferiority of zirconia implants over titanium implants is claimed. <br><br>

Secondary Outcome Measures

Name	Time	Method
Survey of the survival rate of ceramic implants ceramic.implant CI. <br>Survey of survival rates and success rates (USPHS alpha and bravo) of three-unit fixed dental prostheses on ceramic implants (ceramic.implant CI).