NCT06314425

Zirconia Implants: Practice-based Evidence

Prospective Clinical Series With Zirconia Implants

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Swiss Dental Solutions · Industry
• Sex: All
• Age: 18 Years – 85 Years
• Healthy volunteers: Accepted

Summary

This study is a prospective case series clinical study to examine the effectiveness of Ceramic dental implants manufactured by Swiss Dental Solutions (SDS). Participants with an indication from the dentist for teeth extraction and replacement are invited to participate in this study. Participating in this study will involve the use of dental implants manufactured by Swiss Dental Solutions (SDS zirconia dental implants), submission of the case data, including pre-operative information, intra-operative details, and post-operative follow-up data, to the study site and its collaborating partners. The SDS zirconia dental implants used in this research are FDA cleared devices that are available for dental treatments.

Detailed description

To evaluate the effectiveness of one-piece ceramic implants placed into fresh extraction sockets and provide practical clinical evidence, the investigators will assess their performance in defined clinical settings, encompassing a variety of clinical situations, patients, and practitioners. This evaluation, conducted according to a precise surgical and treatment protocol, considers factors such as patient and clinician variability and long-term outcomes in routine clinical practice. Study Question: The cumulative survival rate (CSR), Marginal Bone Level (MBL) and Pink Esthetic Score (PES) of one-piece ceramic implants supporting crowns during a 12-month follow-up period will be determined.

Conditions

• Dental Implants
• Ceramic Implant

Interventions

Type	Name	Description
PROCEDURE	Immediate dental implants placements on fresh sockets after tooth extraction	Zirconia dental implants (SDS®, Swiss Dental Solution, Kreuzlingen, Switzerland) are to be placed within the fresh extraction sockets. The immediate implants are placed using a minimally invasive technique without vertical releasing incisions. Implant placements are performed following the SDS osteotomy protocol after sulcus marginal and crestal incision or flapless surgery. The same surgeon places implants for all patients. Infected sites are debrided using piezo surgery touch.

Timeline

• Start date: 2025-01-03
• Primary completion: 2025-04-24
• Completion: 2026-12-31
• First posted: 2024-03-18
• Last updated: 2025-06-06

Locations

1 site across 1 country: United States