Multicenter, randomized, controlled clinical study comparing immediate loading to delayed loading of dental implants using a fully digital workflow
Zusammenfassung der Studie
In this study, two procedures for final crown placement after implant insertion are compared. Patients are randomly assigned to two treatment groups: in one group, the final crown is placed three days after implantation, while patients in the other group receive the final crown three months after implantation. Patients are then observed for up to one year after crown placement.
(BASEC)
Untersuchte Intervention
The interventions studied are immediate implant loading vs. delayed implant loading.
In the first procedure, an optical intraoral impression is taken immediately after implantation and sent to the dental laboratory. The dental laboratory then fabricates the final reconstruction, which is placed on the patient within three days after implant insertion.
In the second procedure, an optical intraoral impression is taken one month after implantation and sent to the dental laboratory. The dental laboratory fabricates the final reconstruction, and the final reconstruction is placed three months after implantation.
(BASEC)
Untersuchte Krankheit(en)
Tooth loss
(BASEC)
- Patients ≥ 18 years old - Patients requiring at least two unilateral implants in the molar region either in the upper or lower jaw (excluding third molars) (only single-tooth crowns) - Primary implant stability with torque > 30 N (BASEC)
Ausschlusskriterien
- Pregnant or breastfeeding women - Systemic or local conditions that contraindicate implant treatment - Smokers (>10 cigarettes/day) (BASEC)
Studienstandort
Zürich
(BASEC)
Sponsor
Zentrum für Zahnmedizin, Klinik für Rekonstruktive Zahnmedizin, Zurich
(BASEC)
Kontakt für weitere Auskünfte zur Studie
Kontaktperson Schweiz
Prof.Dr. Daniel Thoma
+41 44 634 33 11
Research.RZM@clutterzzm.uzh.chZentrum für Zahnmedizin, Klinik für Rekonstruktive Zahnmedizin
(BASEC)
Allgemeine Auskünfte
University of ZrichCenter of Dental MedicineClinic of Reconstructive Dentistry
+41 44 63433 11
roland.jung@zzm.uzh.ch(ICTRP)
Wissenschaftliche Auskünfte
University of Z?richCenter of Dental MedicineClinic of Reconstructive Dentistry
+41 44 63433 11
roland.jung@zzm.uzh.ch(ICTRP)
Name der bewilligenden Ethikkommission (bei multizentrischen Studien nur die Leitkommission)
Ethikkommission Zürich
(BASEC)
Datum der Bewilligung durch die Ethikkommission
06.07.2021
(BASEC)
ICTRP Studien-ID
DRKS00022286 (ICTRP)
Offizieller Titel (Genehmigt von der Ethikkommission)
Multicenter randomized controlled clinical trial comparing immediate to delayed loading in dental implant treatment applying a full-digital workflow (BASEC)
Wissenschaftlicher Titel
Multicenter randomized controlled clinical trial comparing immediate to delayed loading in dental implant treatment applying a full-digital workflow - IL vs DL (ICTRP)
Öffentlicher Titel
Multicenter randomized controlled clinical trial comparing immediate to delayed loading in dental implant treatment applying a full-digital workflow (ICTRP)
Untersuchte Krankheit(en)
K00-K14Diseases of oral cavity, salivary glands and jaws (ICTRP)
Untersuchte Intervention
Group 1: Immediate implant loading, within 3-7 days after implant placement
Group 2: Delayed implant loading, after 3 months of implant placement (ICTRP)
Studientyp
interventional (ICTRP)
Studiendesign
Allocation: Randomized controlled study; Masking: Open (masking not used); Control: active; Assignment: parallel; Study design purpose: treatment (ICTRP)
Ein-/Ausschlusskriterien
Inclusion criteria: - In need of at least two or more unilateral implants at the posterior region either in the maxilla or the mandible (excl. third molars) (single crowns only)
- Primary implant stability with insertion torque > 30N
- Presence of two adjacent teeth at the implant site
- Adequate oral hygiene (Bleeding on probing <20% Plaque index <20%)
- Capability to comply with the study procedures
- Signed Informed Consent Form (ICTRP)
Exclusion criteria: - Pregnant or lactating women
- Systemic or local conditions presenting a contraindication to implant treatment
- Known or suspected non-compliance, drug or alcohol abuse
- Smokers (>10 cigarettes/day)
- Currently taking drugs that influence bone metabolism
- Use of bisphosphonates in the last 4 years
- History of malignancy, radiotherapy or chemotherapy for malignancy in the past 5 years
Primäre und sekundäre Endpunkte
Patients� satisfaction using Patient Reported Outcome Measures (PROMs) (VAS), after 12 months. (ICTRP)
- Perceived difficulty/ease of use rated by dentists evaluated (VAS)
- Patient�s reported outcome measures (patient�s expectations, and OHIP-14
- Efficiency (time)
- Marginal bone level (implant shoulder to first bone-to-implant-contact) after insertion of the final reconstruction, 6 months and 1-year follow-up
- Implant survival at 6 months and 1-year follow-up
- Schedule of visits plus and additional visits (efficiency)
- Treatment cost
- Peri-implant clinical parameters ( PD,PI, BOP, REC,KER, at the implant sites after insertion of the final reconstruction, at 6 months and at 1-year follow-up
- Implant-supported crown height after insertion of the final reconstruction, at 6 months and 1-year follow-up
- Accuracy of implant position
- Fit of final reconstruction after its insertion
- Technical outcomes (efficacy/USPHS) after insertion of the final reconstruction, and at 1-year follow-up (ICTRP)
Registrierungsdatum
20.01.2022 (ICTRP)
Einschluss des ersten Teilnehmers
31.01.2022 (ICTRP)
Sekundäre Sponsoren
nicht verfügbar
Weitere Kontakte
Roland E. Jung, roland.jung@zzm.uzh.ch, +41 44 63433 11, University of ZrichCenter of Dental MedicineClinic of Reconstructive Dentistry (ICTRP)
Sekundäre IDs
2020-01645 (ICTRP)
Angaben zur Verfügbarkeit von individuellen Teilnehmerdaten
No (ICTRP)
Weitere Informationen zur Studie
http://drks.de/search/en/trial/DRKS00022286 (ICTRP)
Ergebnisse der Studie
Zusammenfassung der Ergebnisse
nicht verfügbar
Link zu den Ergebnissen im Primärregister
nicht verfügbar