Zirconia Implants: Practice-based Evidence (SDS)

Swiss Dental Solutions

Status: Active, not recruiting

Conditions: Ceramic Implant; Dental Implants

Treatments: Procedure: Immediate dental implants placements on fresh sockets after tooth extraction

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT06314425

IRB_20240714

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

Immediate loading of ceramic implants

Experimental group

Description:

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.

Treatment:

Procedure: Immediate dental implants placements on fresh sockets after tooth extraction