Zirconia Implants: Practice-based Evidence

Dental Implants Clinical Trial

— SDS  

Official title:

Prospective Clinical Series With Zirconia Implants

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06314425
• Other study ID #: IRB_20240714
• Status: Enrolling by invitation
• Phase: N/A
• Start date: May 31, 2024
• Est. completion date: December 2025

Study information

• Verified date: March 2024
• Source: Swiss Dental Solutions
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 100
• Est. completion date: December 2025
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Ceramic Implant
• Dental Implants

Intervention

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.

Locations

Country	Name	City	State
United States	Brighton Periodontal & Implant Dental Group	Woodland Hills	California

Sponsors (2)

Lead Sponsor	Collaborator
Swiss Dental Solutions	VISTA Institute for Therapeutic Innovations

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pink Esthetic Score (PES)	The PES parameters are the presence of papilla (mesial and distal), soft tissue, height of marginal gingiva, alveolar processes, and soft tissue color and texture. The values are assessed at specific time points as follows: T(0) immediately after implant placement, T(1) 6 months after implant placement, T(2) 12 months after implant placement. The seven variables are scored on a scale ranging from 0 to 2 points, with a maximum score of 14 and a minimum score of zero in relation to esthetic parameters.	12-month follow-up
Primary	Cumulative Survival Rate (CSR)	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.	12-month follow-up
Secondary	Marginal Bone Loss (MBL)	The vertical bone height is measured mesially and distally on intraoral periapical radiographs. The values are assessed at specific time points as follows: T(0) immediately after implant placement, T(1) 6 months after implant placement, T(2) 12 months after implant placement.; The clinical success of the implants is defined in four groups as follows: Group I < 2 mm of radiographic bone loss without tenderness, mobility, or exudate.; Group II radiographic bone loss of 2-4 mm without mobility or tenderness.; Group III radiographic bone loss > 4 mm but less than half the implant length with no mobility or exudation.; Group IV implant loss.	12-month follow-up