Multicenter, randomized, controlled clinical study comparing immediate loading to delayed loading of dental implants using a fully digital workflow

South Korea, Switzerland (ICTRP)

ID di studio ICTRP
DRKS00022286 (ICTRP)

Titolo ufficiale (approvato dal comitato etico)
Multicenter randomized controlled clinical trial comparing immediate to delayed loading in dental implant treatment applying a full-digital workflow (BASEC)

Titolo accademico
Multicenter randomized controlled clinical trial comparing immediate to delayed loading in dental implant treatment applying a full-digital workflow - IL vs DL (ICTRP)

Titolo pubblico
Multicenter randomized controlled clinical trial comparing immediate to delayed loading in dental implant treatment applying a full-digital workflow (ICTRP)

Malattie studiate

K00-K14Diseases of oral cavity, salivary glands and jaws (ICTRP)

Intervento studiato
Group 1: Immediate implant loading, within 3-7 days after implant placement
Group 2: Delayed implant loading, after 3 months of implant placement (ICTRP)

Tipo di studio
interventional (ICTRP)

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

Criteri di inclusione/esclusione
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

Endpoint primari e secondari
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)

Data di registrazione
20.01.2022 (ICTRP)

Inclusione del primo partecipante
31.01.2022 (ICTRP)

Sponsor secondari
non disponibile

Contatti aggiuntivi
Roland E. Jung, roland.jung@zzm.uzh.ch, +41 44 63433 11, University of ZrichCenter of Dental MedicineClinic of Reconstructive Dentistry (ICTRP)

ID secondari
2020-01645 (ICTRP)

Risultati-Dati individuali dei partecipanti
No (ICTRP)

Ulteriori informazioni sullo studio
http://drks.de/search/en/trial/DRKS00022286 (ICTRP)