Ceramic Dental Implants for Tooth Replacement

(SDS Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates the effectiveness of ceramic dental implants for tooth replacement. The focus is on implants made by Swiss Dental Solutions, which the FDA has already cleared. These zirconia implants are a type of ceramic dental implant. Individuals needing one to three teeth removed and replaced may qualify for this study. Participants must be available for follow-up for at least a year and maintain a complete follow-up record. This study suits those prepared to have their teeth extracted and replaced with new ceramic ones. As an unphased trial, it offers the opportunity to contribute to dental research and potentially benefit from advanced ceramic implant technology.

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 prior data suggests that these ceramic dental implants are safe for tooth replacement?

Research has shown that zirconia dental implants are generally safe. Studies indicate a high success rate, with about 95% lasting through the first year and only a slight decrease in success each year after. Patients typically experience minimal pain with these implants, which are designed to last a lifetime and offer a strong solution for replacing teeth. Zirconia is bioinert, meaning it doesn't react with or move to other parts of the body.

Additionally, the FDA has approved these implants for dental treatments, providing extra assurance of their safety. While some studies mention issues with certain designs of zirconia implants, the specific type used in this trial—made by Swiss Dental Solutions—has demonstrated a strong record for safety and effectiveness. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about zirconia implants for tooth replacement because they offer a metal-free alternative to traditional titanium implants. This is particularly appealing for patients with metal sensitivities or allergies. Zirconia is known for its strength and biocompatibility, which can lead to better integration with the bone and potentially faster healing. Additionally, zirconia’s tooth-like color provides a more natural aesthetic, which is a significant advantage over metal implants.

What evidence suggests that ceramic dental implants are effective for tooth replacement?

Research has shown that zirconia dental implants, under study in this trial, hold promise for tooth replacement. A recent study found that 97.2% of zirconia implants remained stable over five years, indicating reliability. Another study found that zirconia implants cause bone loss similar to titanium implants, which are more commonly used. Patients have also reported satisfaction with zirconia implants. These findings suggest that zirconia implants could be a dependable choice for dental restoration. ^{4 6 7 8 9}

Who Is on the Research Team?

Etyene Schnurr, DMD PhD DSc MSc

Principal Investigator

Vizstara Professional Education, Clinical and R & D

Are You a Good Fit for This Trial?

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 for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10746607/

Clinical outcomes of zirconia implants: a systematic review ... The clinical outcomes observed for zirconia dental implants are very promising, although these have not yet been extensively studied as titanium alloy implants.

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/clr.70049

Ten‐Year Results of a Prospective Study on One‐Piece ... The survival rate of the SC at the 10-year follow-up was 85.7%, but the success rate was only 11.4% (Figures 4-6). 4 Discussion. This ...

3. jpro.springeropen.com jpro.springeropen.com/articles/10.1186/s41687-025-00839-8

Patient-reported outcomes of zirconia dental implants Nevertheless, a recent meta-analysis estimated a survival rate of 97.2% (confidence interval [CI], 94.7–99.1) in five years for zirconia ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0300571224000733

Zirconia dental implants; the relationship between design ... Promising 5-year clinical outcomes were found for one-piece zirconia implants with no difference between different diameters and lengths.

5. eurjmedres.biomedcentral.com eurjmedres.biomedcentral.com/articles/10.1186/s40001-025-02488-5

Clinical effectiveness of Zirconia versus titanium dental ... Notably, zirconia implants exhibit similar marginal bone loss to titanium implants for a single restoration with good patient satisfaction, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12009782/

Prospective clinical study to evaluate the success and survival ... The two-piece zirconia implant system with screw-retained restorations showed unsatisfactory survival rates. The combination of ceramic implants ...

7. drcarlieamore.com drcarlieamore.com/sds-ceramic-zirconia-implants

SDS Ceramic Zirconia Implants Durability: These implants are designed to last a lifetime, offering a long-term solution for dental restoration. Minimal Pain: Patients often report little to ...

8. maplespub.com maplespub.com/article/immunologically-neutral-dental-implants-ceramic-zirconia-implants

Immunologically Neutral Dental Implants Ceramic (Zirconia ... Zirconia does not conduct heat or electricity and is resistant to chemical corrosion. It is a bioinert material that will not travel to other locations in the ...

9. nature.com nature.com/articles/s41415-024-7123-3

One-piece versus two-piece ceramic dental implants In this narrative review, a structured comparison between one-piece and two-piece zirconia dental implants is highlighted. Ceramic dental ...