Multicenter, randomized, controlled clinical study comparing immediate loading to delayed loading of dental implants using a fully digital workflow
Résumé de l'étude
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)
Intervention étudiée
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)
Maladie en cours d'investigation
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)
Critères d'exclusion
- Pregnant or breastfeeding women - Systemic or local conditions that contraindicate implant treatment - Smokers (>10 cigarettes/day) (BASEC)
Lieu de l’étude
Zurich
(BASEC)
Sponsor
Zentrum für Zahnmedizin, Klinik für Rekonstruktive Zahnmedizin, Zurich
(BASEC)
Contact pour plus d'informations sur l'étude
Personne de contact en Suisse
Prof.Dr. Daniel Thoma
+41 44 634 33 11
Research.RZM@clutterzzm.uzh.chZentrum für Zahnmedizin, Klinik für Rekonstruktive Zahnmedizin
(BASEC)
Informations générales
University of ZrichCenter of Dental MedicineClinic of Reconstructive Dentistry
+41 44 63433 11
roland.jung@zzm.uzh.ch(ICTRP)
Informations scientifiques
University of Z?richCenter of Dental MedicineClinic of Reconstructive Dentistry
+41 44 63433 11
roland.jung@zzm.uzh.ch(ICTRP)
Nom du comité d'éthique approbateur (pour les études multicentriques, uniquement le comité principal)
Commission cantonale de Zurich
(BASEC)
Date d'approbation du comité d'éthique
06.07.2021
(BASEC)
Identifiant de l'essai ICTRP
DRKS00022286 (ICTRP)
Titre officiel (approuvé par le comité d'éthique)
Multicenter randomized controlled clinical trial comparing immediate to delayed loading in dental implant treatment applying a full-digital workflow (BASEC)
Titre académique
Multicenter randomized controlled clinical trial comparing immediate to delayed loading in dental implant treatment applying a full-digital workflow - IL vs DL (ICTRP)
Titre public
Multicenter randomized controlled clinical trial comparing immediate to delayed loading in dental implant treatment applying a full-digital workflow (ICTRP)
Maladie en cours d'investigation
K00-K14Diseases of oral cavity, salivary glands and jaws (ICTRP)
Intervention étudiée
Group 1: Immediate implant loading, within 3-7 days after implant placement
Group 2: Delayed implant loading, after 3 months of implant placement (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: - 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
Critères d'évaluation principaux et secondaires
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)
Date d'enregistrement
20.01.2022 (ICTRP)
Inclusion du premier participant
31.01.2022 (ICTRP)
Sponsors secondaires
non disponible
Contacts supplémentaires
Roland E. Jung, roland.jung@zzm.uzh.ch, +41 44 63433 11, University of ZrichCenter of Dental MedicineClinic of Reconstructive Dentistry (ICTRP)
ID secondaires
2020-01645 (ICTRP)
Résultats-Données individuelles des participants
No (ICTRP)
Informations complémentaires sur l'essai
http://drks.de/search/en/trial/DRKS00022286 (ICTRP)
Résultats de l'essai
Résumé des résultats
non disponible
Lien vers les résultats dans le registre primaire
non disponible