Ceramic Dental Implants for Tooth Replacement

(SDS Trial)

Recruiting at 1 trial location

Overseen By Etyene Schnurr, Prof DMD PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Swiss Dental Solutions

Must not be taking: Bisphosphonates

Disqualifiers: Head and neck irradiation, Uncontrolled diabetes, Immunocompromised, Heavy smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

Duration: Immediate

100 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you are taking bisphosphonates or medications that cause jaw problems, you may not be eligible to participate.

What data supports the effectiveness of the treatment Zirconia Implants for tooth replacement?

Research shows that zirconia implants have good survival and success rates, with minimal bone loss around the implant area, making them a reliable option for tooth replacement. Studies also indicate that zirconia implants can be as effective as titanium implants, especially when surface modifications are applied to improve bone integration. ^{1 2 3 4 5}

Is it safe to use ceramic (zirconia) dental implants in humans?

Research shows that zirconia implants are generally safe for use in humans, as they are biocompatible (compatible with living tissue) and have been studied for their effects on bone and gum cells without showing harmful effects. ^{2 5 6 7 8}

How do zirconia implants differ from other dental implant treatments?

Zirconia implants are unique because they are made from a tooth-colored ceramic material, offering a metal-free alternative to traditional titanium implants. They are known for their superior biocompatibility and aesthetic appeal, especially for patients who prefer not to have metal in their bodies. Additionally, zirconia implants have a micro-rough surface that supports bone integration, similar to titanium implants, but with potentially fewer peri-implant infections. ^{7 9 10 11 12}

Research Team

Etyene Schnurr, DMD PhD DSc MSc

Principal Investigator

Vizstara Professional Education, Clinical and R & D

Eligibility Criteria

This trial is for patients needing tooth extraction and replacement with dental implants. Participants must be available for at least one year of follow-up, require single or multiple teeth replacement up to three teeth, and have complete medical records including post-operative radiographs.

Inclusion Criteria

I need implants for up to 3 teeth that will be or have been extracted.

Availability of complete follow-up data in medical records

I can provide dental X-rays taken after surgery.

Exclusion Criteria

Heavy Smoking of >10 cigarettes per day

I have had radiation therapy to my head or neck.

I have taken medications that could cause jawbone problems.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo tooth extraction and immediate loading of ceramic implants using a minimally invasive approach

Immediate

1 visit (in-person)

Follow-up

Participants are monitored for implant survival, Pink Esthetic Score, and Marginal Bone Loss over a 12-month period

12 months

3 visits (in-person) at T(0), T(1), and T(2)

Treatment Details

Interventions

• Zirconia Implants

Trial Overview The study tests the effectiveness of Ceramic (zirconia) dental implants from Swiss Dental Solutions after immediate placement in fresh sockets following tooth extraction. It's a prospective case series study collecting pre-op, intra-op, and post-op data.

Participant Groups

Group I: Immediate loading of ceramic implants Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Swiss Dental Solutions

Lead Sponsor

Trials

1

Recruited

100+

VISTA Institute for Therapeutic Innovations

Collaborator

Trials

1

Recruited

100+

References

1. Japan pubmed.ncbi.nlm.nih.gov

A systematic review and meta-analysis on the clinical outcome of zirconia implant-restoration complex. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Zirconia Implants and Marginal Bone Loss: A Systematic Review and Meta-Analysis of Clinical Studies. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Osseointegration of zirconia implants with different surface characteristics: an evaluation in rabbits. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Survival and success of zirconia compared with titanium implants: a systematic review and meta-analysis. [2023]

5. Denmark pubmed.ncbi.nlm.nih.gov

Three-year analysis of zirconia implants used for single-tooth replacement and three-unit fixed dental prostheses: A prospective multicenter study. [2018]

6. England pubmed.ncbi.nlm.nih.gov

Titanium and zirconium release from titanium- and zirconia implants in mini pig maxillae and their toxicity in vitro. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Bone tissue responses to surface-modified zirconia implants: A histomorphometric and removal torque study in the rabbit. [2022]

8. Germany pubmed.ncbi.nlm.nih.gov

Influence of CAD/CAM zirconia for implant-abutment manufacturing on gingival fibroblasts and oral keratinocytes. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Prospective Clinical Multicenter Study Evaluating the 5-Year Performance of Zirconia Implants in Single-Tooth Gaps. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

EAO Position Paper: Current Level of Evidence Regarding Zirconia Implants in Clinical Trials. [2022]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Implant Supported Fixed Dental Prostheses Using a New Monotype Zirconia Implant-A Case Report. [2020]

12. England pubmed.ncbi.nlm.nih.gov

A prospective clinical study to evaluate the performance of zirconium dioxide dental implants in single-tooth edentulous area: 3-year follow-up. [2019]