Zirconia Implants: Practice-based Evidence

NCT06314425 | Active Not Recruiting DMC

• 1 other identifier: IRB_20240714
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Implants; Ceramic Implant

Keywords

ceramic implants; titanium implants; peri-implantitis; marginal bone loss; soft tissue; bone augmentation; immediate implantation; dental implants; immediate loading

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Marginal Bone Loss (MBL)

  12-month follow-up

Other Outcomes (1)

• Pink Esthetic Score (PES)

  12-month follow-up

Study Arms (1)

Immediate loading of ceramic implants

EXPERIMENTAL

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.

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

Interventions

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.

Immediate loading of ceramic implants

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Swiss Dental Solutions: lead

Study Sites (1)

Vizstara Professional Education

Englewood Cliffs, New Jersey, 07632, United States

Location

MeSH Terms

Conditions

Peri-Implantitis

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Etyene Schnurr, DMD PhD DSc MSc

  Vizstara Professional Education, Clinical and R & D

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 7, 2024
• First Posted: March 18, 2024
• Study Start: January 3, 2025
• Primary Completion: April 24, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: June 6, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)