K08.1
Conditions
Interventions
Group 1: Implantation and immediate restoration using a two-part ceramic implant in a single-tooth gap (healed alveolus). Final loading/restoration after 8 to 12 weeks. Subsequent follow-up observatio
Sponsors
Zentrum der Zahn-, Mund- und KieferheilkundeCarolinum Zahnärztliches Universitäts-Institut gGmbHPoliklinik für Zahnärztliche Chirurgie und Implantologie
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Voluntarily signed informed consent form before any study related action. 2. Males and females with age at least 18 years old. 3. Single tooth restorations in partially edentulous mandible and/or maxilla: single tooth gaps with sufficient bone for the placement of an implant with a diameter of 4.5mm. Adjacent mesial and distal teeth must be natural teeth (roots). 4. Tooth extraction at least 12 weeks prior to implant placement. 5. Opposing dentition must be natural teeth or fixed restoration. 6. Systematically healthy with no contraindications for oral surgical procedures. 7. 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: 1. Smokers: >10 cigarettes per day or cigar equivalents or chewing tobacco. 2. Systemic disease that would interfere with dental implant therapy (e.g. uncontrolled diabetes). 3. Uncontrolled para-functional diseases (bruxism, clenching or grinding of teeth). 4. Disorders that impede the ability of patients to maintain adequate oral hygiene. 5. 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. 6. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Implant success as evidenced by a standardized composite outcome, including clinical parameters: Bleeding On Probing (BOP), Mucosal Recession (MR) and Probing Pocket Depths (PD) one year after baseline. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary objectives include evaluation of implant stability, hard and soft tissue health, implant survival and patient satisfaction up to one year after loading. Parameters: - Insertion torque at implant placement - ISQ at implant placement and at final loading (RFA, Osstell) - Soft tissue thickness at implant placement - Plaque index (mPI; starting from final loading) - Patient related outcome measures (Questionnaire: comfort, appearance, chewing, taste, fit, general satisfaction; starting from final loading) - Radiographic evaluation/ bone level change from usual x-rays done during the implant treatment - Complications / Safety | — |
Countries
Germany
Contacts
Public ContactGeorgia Trimpou
Zentrum der Zahn-, Mund- und KieferheilkundeCarolinum Zahnärztliches Universitäts-Institut gGmbHPoliklinik für Zahnärztliche Chirurgie und Implantologie
Outcome results
None listed