Zirconia Implants: Practice-based Evidence

NCT ID: NCT06314425

Last Updated: 2025-06-06

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-01-03
• Study Completion Date: 2026-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Immediate loading of ceramic implants

Tooth/teeth are extracted with minimally invasive approach using piezo surgery and when necessary sectioning after local anesthesia (Articaine 40 mg/mL with epinephrine 10 μg/mL; or Lidocaine 20mg/ml with 10 ug/ml). Extraction sockets are thoroughly degranulated to remove all remnants of soft tissue and residual restorations or material which may have extended beyond the tooth apex. After copious irrigation, the socket condition is recorded, which includes, thickness and location of buccal/facial crestal alveolar bone.

Group Type: EXPERIMENTAL

Immediate dental implants placements on fresh sockets after tooth extraction

Intervention Type: PROCEDURE

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.

Interventions

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.

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• The need for implant placement in position of single or multiple teeth to be extracted and to replace up to 3 teeth
• Availability of patient for a minimum follow-up of one year following implantation
• Availability of complete follow-up data in medical records
• Availability of post-operative and follow-up periapical radiographs

Exclusion Criteria

• History of head and neck irradiation
• History of bisphosphonate or medications that induce osteonecrosis of the jaw
• Untreated systemic diseases that are known to affect wound healing, such as uncontrolled diabetes mellitus
• Immunocompromised or immunoproliferative diseases
• Heavy Smoking of >10 cigarettes per day

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Swiss Dental Solutions

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Etyene Schnurr, DMD PhD DSc MSc

Role: STUDY_DIRECTOR

Vizstara Professional Education, Clinical and R & D

Locations

Vizstara Professional Education

Englewood Cliffs, New Jersey, United States

Countries

United States

Other Identifiers

IRB_20240714

Identifier Type: -

Identifier Source: org_study_id