Comparison of loading protocols under a full-digital workflow
- Conditions
- Not Applicable
- Registration Number
- KCT0007935
- Lead Sponsor
- Zurich University
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 62
1. = 18 years of age
2. 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)
3. Primary implant stability with insertion torque > 30N
4. Presence of two adjacent teeth at the implant site
5. Adequate oral hygiene (Bleeding on probing <20%; Plaque index <20%);
6. Capability to comply with the study procedures
7. Signed Informed Consent Form
1. Pregnant or lactating women
2. Systemic or local conditions presenting a contraindication to implant treatment
3. Known or suspected non-compliance, drug or alcohol abuse
4. Smokers (>10 cigarettes/day)
5. Currently taking drugs that influence bone metabolism
6. Use of bisphosphonates in the last 4 years
7. History of malignancy, radiotherapy or chemotherapy for malignancy in the past 5 years
Study & Design
- Study Type
- Interventional Study
- 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 Profilometric changes of the buccal soft tissues via superimposing the digital impressions;Accuracy of implant position by means of cone-beam CT;Fit of final reconstruction measured by the need for adjustment either by the dentist or the dental technician;Technical outcomes (efficacy/USPHS) after insertion of the final reconstruction, and at 1-year follow-up;Patient’s reported outcome measures;Perceived difficulty/ease of use rated by dentists at implant placement and at the visit for Final Prosthesis (BL1 and BL2);Efficiency (time) assessed at implant placement and at visit of Final Prosthesis (BL1 and BL2);Marginal bone level (implant shoulder to first bone-to-implant-contact) after final reconstruction (at visits for Evaluation of Final Prosthesis), 6 months and 1-year follow-up;Implant survival at 6 months and 1-year follow-up;Schedule of visits and additional visits (efficiency);Treatment cost;Peri-implant clinical parameters (PD, REC and KER, PI, BOP) at the implant sites and adjacent teeth