Esthetic Outcome, Clinical Performance, Patient Perception and Cost-Time Efficiency of Implant-supported Single Crowns influenced by the Prosthetic Workflow – a Randomized Clinical Trial in the Esthetic Zone
- Conditions
- Missing tooth, single tooth gap
- Registration Number
- DRKS00032124
- Lead Sponsor
- Zentrum für Zahnmedizin, Klinik für Rekonstruktive Zahnmedizin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 60
1. Die Probanden müssen vor jeder studienbezogenen Handlung freiwillig die Einverständniserklärung unterzeichnet haben.
2. Erfolgreich osseointegriertes Straumann-Einzelzahnimplantat auf Knochenniveau 4,1 mm (BL/BLT), das mindestens 8 Wochen nach der Zahnextraktion eingesetzt wurde
3. Implantatachse kompatibel mit transokklusaler Schraubenretention (Schraubenzugang palatinal der Inzisalkanten)
1. Systemic disease that would interfere with dental implant therapy (e.g. uncontrolled diabetes, i.v. bisphosphonate intake)
2. Any contraindications for oral surgical procedures
3. History of local irradiation therapy in the head-neck area
4. Patients who smoke >10 cigarettes per day or tobacco equivalents or chew tobacco
5. Subjects who have undergone administration of any investigational device within 30 days of enrolment in the study
6. 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
7. Physical or mental handicaps that would interfere with the ability to perform adequate oral hygiene
8. Pregnant or breastfeeding women
9. Existing implants in the adjacent position
10. Removable dentures in the opposing dentition
11. Patients with inadequate oral hygiene (Periodontal examination PGU > 2) or unmotivated for adequate home care
12. Lack of primary stability of the implant
13. Inappropriate implant position for a screw-retained restoration
14. Severe bruxing or clenching habits
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To compare the influence of the prosthetic workflow on the overall esthetic outcome: PES/WES index at baseline, 1, 3, and 5 years.
- Secondary Outcome Measures
Name Time Method Time (in min) and cost (in CHF) analysis of fabrication of final implant crowns <br>•Crestal bone level changes at the implant site (mesial and distal) between baseline and 1, 3, 5 years <br>•Implant survival rate at baseline, 1, 3, 5 years <br>•Mechanical complications / failures at baseline,1, 3, 5 years <br>•Technical complications / failures at baseline,1, 3, 5 years <br>•Plaque assessments on healing abutments <br>•Clinical Parameters: Examination of standard peri-implant soft tissue parameters (mod Pl, BOP, PD, KM) at six sites of each implant (except KM: only buccal) at baseline, 1, 3, 5 years <br>•PICI-Index after baseline, 1, 3, 5 years<br>•Patient questionnaires (PROMs Prothetik) after baseline, 1, 3, 5 years using numerical rating scale (NRS) and OHIP-G14 questionnaire<br><br>