K08.1
Conditions
Interventions
Group 1: Single tooth restoration with a ceramic two-piece implant system and a single crown.
Sponsors
Charité Centrum Zahn-, Mund- und Kieferheilkunde, Zahnärztliche Prothetik, Alterszahnmedizin und Funktionslehre
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: - Males and females with at least 18 years of age. - Single tooth gaps at least 7.5 mm wide in maxilla or mandible (#1-#7 FDI) allowing the placement of a single implant. Adjacent mesial and distal tooth must be natural tooth. - Adequate bone quality and quantity at the implant site to permit the insertion of a zirconia implant. - Opposing dentition must be natural teeth or fixed restoration. - If patient undergo a large bone augmentation (with autogenous bone block) a delay of 3.5 months must elapse before implantation. - Patient has been informed of the follow-up visits and is willing to return to the clinical center for these follow-up visits.
Exclusion criteria
Exclusion criteria: - Free-end situations - Systemic disease that would interfere with dental implant therapy (e.g. uncontrolled diabetes) - Patients who smoke >10 cigarettes per day or cigar equivalents, or who chew tobacco - Cardiovascular disease - Coagulation disorders (including taking anticoagulants) - Metabolic bone disease - Chemotherapy or radiation treatment - Chronic inflammation - Metabolic or systemic disorders associated with lesions and/or bone healing - The use of pharmaceutical products that block or modify bone healing - Uncontrolled para-functional diseases (bruxism, clenching or grinding of teeth) - Insufficient inter-arc gap - Intraoral infection - Insufficient coverage of the soft tissue - Disorders that impede the ability of patients to maintain adequate oral hygiene - 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Implant survival and success at 12 months post-loading. Success criteria according to Buser and the use or radiographs. Evaluation of any complications and adverse events. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in bone level, changes in soft tissue, aesthetical outcome, patient satisfaction - all at 6, 12, 18, 24, 36, 48, 60 months post-loading and all by evaluating the following parameters: -mesial/distal bone contact at implant (radiograph) -Papilla score (Jemt) - Soft tissue recession (Grunder) - Pink and White esthetic score (Belser) - Volume of soft tissue (intra-oral scan) - Plaque assessment (PPI) - Bleeding on probing (BOP) - Modified gingival index (MGI) - Porbing pocket depths (PPD) - Width of the keratinized mucosa (KM) - Matrix-metalloproteinase 8 (immunology) - Patient satisfaction (PROMs) | — |
Countries
Germany
Contacts
Public ContactFlorian Beuer
Charité Centrum Zahn-, Mund- und Kieferheilkunde, Zahnärztliche Prothetik, Alterszahnmedizin und Funktionslehre
Outcome results
None listed