Zirconia Implants: Practice-based Evidence

Last updated: December 2, 2024
Sponsor: Swiss Dental Solutions
Overall Status: Active - Enrolling

Phase

N/A

Condition

Medical Prosthetics

Treatment

Immediate dental implants placements on fresh sockets after tooth extraction

Clinical Study ID

NCT06314425
IRB_20240714
  • Ages 18-85
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • The need for implant placement in position of single or multiple teeth to beextracted 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

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 asuncontrolled diabetes mellitus

  • Immunocompromised or immunoproliferative diseases

  • Heavy Smoking of >10 cigarettes per day

Study Design

Total Participants: 100
Treatment Group(s): 1
Primary Treatment: Immediate dental implants placements on fresh sockets after tooth extraction
Phase:
Study Start date:
January 03, 2025
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Brighton Periodontal & Implant Dental Group

    Woodland Hills, California 91367
    United States

    Site Not Available

  • Vizstara Professional Education

    Englewood Cliffs, New Jersey 07632
    United States

    Site Not Available

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