Zirconia Implants: Practice-based Evidence

Not Applicable

Active, not recruiting

• Conditions: Dental Implants; Ceramic Implant

• Registration Number: NCT06314425
• Lead Sponsor: Swiss Dental Solutions

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.

Study Timeline

• Study First Submitted: 2024-03-07
• Study First Submitted QC: 2024-03-15
• Study First Posted: 2024-03-18
• Study Start: 2025-01-03
• Primary Completion: 2025-04-24
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-04
• Last Update Posted: 2025-06-06
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Cumulative Survival Rate (CSR)	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 Outcome Measures

Name	Time	Method
Marginal Bone Loss (MBL)	12-month follow-up	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.

Trial Locations

Locations (1)

Vizstara Professional Education; 🇺🇸 Englewood Cliffs, New Jersey, United States