Aesthetic outcome, clinical performance, patient perception, and cost-time efficiency of implant-supported single crowns under the influence of the prosthetic workflow - a randomized clinical study in the aesthetic zone

Switzerland (ICTRP)

ICTRP Trial ID
DRKS00032124 (ICTRP)

Official title (approved by ethics committee)
Esthetic Outcome, Clinical Performance, Patient Perception and Cost-Time Efficiency of Implant-supported Single Crowns influenced by the Prosthetic Workflow – a Random-ized Clinical Trial in the Esthetic Zone (BASEC)

Academic title
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 - Ceramic Esthetic (ICTRP)

Public title
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 (ICTRP)

Disease under investigation
Missing tooth, single tooth gap (ICTRP)

Intervention under investigation
Group 1: Using a zirconium dioxide healing abutment, a provisional phase with soft tissue conditioning following the dynamic compression technique, a customized CAD/CAM designed abutment made of zirconium dioxide and veneered with individualized hand- build up ceramic.
Group 2: Using a titanium healing abutment, no provisional phase and a direct finalization of the crown with a Vario Base Abutment using monolithic ceramic which is individualized by extrinsic staining.
Group 3: Using a CAD/CAM designed individual mucosa former made of zirconium dioxide for 3 months, no provisional phase, the crown is finalized with a customized CAD/CAM designed abutment made of zirconium dioxide and veneered with individualized hand- build up ceramic. (ICTRP)

Type of trial
interventional (ICTRP)

Trial design
Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: treatment (ICTRP)

Inclusion/Exclusion criteria
Inclusion criteria: 1. Die Probanden mssen vor jeder studienbezogenen Handlung freiwillig die Einverstndniserklrung 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) (ICTRP)

Exclusion criteria: 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

Primary and secondary end points
To compare the influence of the prosthetic workflow on the overall esthetic outcome: PES/WES index at baseline, 1, 3, and 5 years. (ICTRP)

Time (in min) and cost (in CHF) analysis of fabrication of final implant crowns
�Crestal bone level changes at the implant site (mesial and distal) between baseline and 1, 3, 5 years
�Implant survival rate at baseline, 1, 3, 5 years
�Mechanical complications / failures at baseline,1, 3, 5 years
�Technical complications / failures at baseline,1, 3, 5 years
�Plaque assessments on healing abutments
�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
�PICI-Index after baseline, 1, 3, 5 years
�Patient questionnaires (PROMs Prothetik) after baseline, 1, 3, 5 years using numerical rating scale (NRS) and OHIP-G14 questionnaire

(ICTRP)

Registration date
22.06.2023 (ICTRP)

Incorporation of the first participant
14.08.2024 (ICTRP)

Secondary sponsors
not available

Additional contacts
Daniel Thoma, daniel.thoma@zzm.uzh.ch, +41 44 634 43 05, Zentrum fr Zahnmedizin, Klinik fr Rekonstruktive Zahnmedizin (ICTRP)

Secondary trial IDs
not available

Results-Individual Participant Data (IPD)
No (ICTRP)

Further information on the trial
http://drks.de/search/en/trial/DRKS00032124 (ICTRP)