Prospective Clinical Series With Zirconia Implants
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dental Implants
- Sponsor
- Swiss Dental Solutions
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Cumulative Survival Rate (CSR)
- Status
- Active, not recruiting
- Last Updated
- 11 months ago
Overview
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.
Investigators
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
Outcomes
Primary Outcomes
Cumulative Survival Rate (CSR)
Time Frame: 12-month follow-up
The cumulative survival rate is determined as the percentage of implants that remained in place over the observation period for each patient. 100% of survival is defined as absence of implant loss.
Secondary Outcomes
- Marginal Bone Loss (MBL)(12-month follow-up)