Zirconia Implants: Practice-based Evidence (SDS)

Prospective Clinical Series With Zirconia Implants

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.

Study Overview

• Status: Recruiting
• Conditions: Dental Implants; Ceramic Implant
• Intervention / Treatment: Procedure: Immediate dental implants placements on fresh sockets after tooth extraction

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Etyene Schnurr, Prof DMD PhD; Phone Number: 41 0797213110; Email: etyene.schnurr@swiss-biohealth.com
• Study Contact Backup: Name: Homayoun H. Zadeh, DDS PhD; Phone Number: (818) 703-7733; Email: homazadeh@gmail.com

Study Locations

• United States
  • California
    • Woodland Hills, California, United States, 91367
      • Recruiting
      • Brighton Periodontal & Implant Dental Group
      • Contact: Homayoun Zadeh, PhD, DDS; Phone Number: 818-703-7733; Email: homazadeh@gmail.com
      • Contact: Etyene Schnurr, PhD, DDM; Phone Number: 0797213110; Email: etyene.schnurr@swiss-biohealth.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Immediate loading of ceramic implants; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Marginal Bone Loss (MBL)	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.	12-month follow-up

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pink Esthetic Score (PES)	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.	12-month follow-up

Collaborators and Investigators

• Sponsor: Swiss Dental Solutions
• Collaborators: VISTA Institute for Therapeutic Innovations
• Investigators: Principal Investigator: Homayoun Zadeh, DDS PhD, VISTA Institute for Therapeutic Innovations

Study record dates

Study Major Dates

• Study Start (Estimated): April 28, 2024
• Primary Completion (Estimated): May 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: March 7, 2024
• First Submitted That Met QC Criteria: March 15, 2024
• First Posted (Actual): March 18, 2024

Study Record Updates

• Last Update Posted (Actual): April 16, 2024
• Last Update Submitted That Met QC Criteria: April 15, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: dental implants; bone augmentation; peri-implantitis; immediate loading; soft tissue; marginal bone loss; immediate implantation; ceramic implants; titanium implants
• Other Study ID Numbers: IRB_20240714

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No