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)

Identifiant de l'essai ICTRP
DRKS00032124 (ICTRP)

Titre officiel (approuvé par le comité d'éthique)
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)

Titre académique
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)

Titre public
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)

Maladie en cours d'investigation
Missing tooth, single tooth gap (ICTRP)

Intervention étudiée
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 d'essai
interventional (ICTRP)

Plan de l'étude
Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: treatment (ICTRP)

Critères d'inclusion/exclusion
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

Critères d'évaluation principaux et secondaires
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)

Date d'enregistrement
22.06.2023 (ICTRP)

Inclusion du premier participant
14.08.2024 (ICTRP)

Sponsors secondaires
non disponible

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

ID secondaires
non disponible

Résultats-Données individuelles des participants
No (ICTRP)

Informations complémentaires sur l'essai
http://drks.de/search/en/trial/DRKS00032124 (ICTRP)