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NCT Number: NCT06314425

Zirconia Implants: Practice-based Evidence

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Dental Implants Ceramic Implant Mouth Diseases Peri-Implantitis Periodontal Diseases Stomatognathic Diseases

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Vizstara Professional Education

Englewood Cliffs, New Jersey, 07632, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immediate dental implants placements on fresh sockets after tooth extraction

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.

Primary outcomes

  1. 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

  1. Marginal Bone Loss (MBL)

    Time frame: 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.

Other outcomes

  1. Pink Esthetic Score (PES)

    Time frame: 12-month follow-up

    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.

Sponsors and collaborators

Lead sponsor

Swiss Dental Solutions

Industry

Registry information

Official study title

Prospective Clinical Series With Zirconia Implants

Acronym: SDS

Important dates

Study start
2025
Primary completion
2025
Study completion
2026
First posted
Mar 18, 2024
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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