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

Not Applicable

Conditions: K00-K14
Diseases of oral cavity, salivary glands and jaws

Registration Number: DRKS00022286

Lead Sponsor: niversity of ZürichCenter of Dental MedicineClinic of Reconstructive Dentistry

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 62

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

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

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Patients’ satisfaction using Patient Reported Outcome Measures (PROMs) (VAS), after 12 months.

Secondary Outcome Measures

Name	Time	Method
- Perceived difficulty/ease of use rated by dentists evaluated (VAS)<br>- Patient’s reported outcome measures (patient’s expectations, and OHIP-14<br>- Efficiency (time)<br>- Marginal bone level (implant shoulder to first bone-to-implant-contact) after insertion of the final reconstruction, 6 months and 1-year follow-up <br>- Implant survival at 6 months and 1-year follow-up <br>- Schedule of visits plus and additional visits (efficiency)<br>- Treatment cost <br>- 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<br>- Implant-supported crown height after insertion of the final reconstruction, at 6 months and 1-year follow-up <br>- Accuracy of implant position <br>- Fit of final reconstruction after its insertion<br>- Technical outcomes (efficacy/USPHS) after insertion of the final reconstruction, and at 1-year follow-up<br>