Dental ImplantsSDSNCT06314425
Zirconia Implants: Practice-based Evidence
A study testing Immediate dental implants placements on fresh sockets after tooth extraction in people with Dental Implants and Ceramic Implant, run by Swiss Dental Solutions at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implants, Ceramic Implant
- What is being tested?
- Immediate dental implants placements on fresh sockets after tooth extraction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 3 Jan 2025to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Vizstara Professional Education
Englewood Cliffs, New Jersey, 07632
About this study
Official title: 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.
Read the 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.
- Conditions
- Dental Implants, Ceramic Implant
- Being tested
- Immediate dental implants placements on fresh sockets after tooth extraction
- Keywords
- ceramic implants, titanium implants, peri-implantitis, marginal bone loss, soft tissue, bone augmentation, immediate implantation, dental implants, immediate loading
- Medical subject headings
- Peri-Implantitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate dental implants placements on fresh sockets after tooth extractionProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Immediate dental implants placements on fresh sockets after tooth extraction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12-month follow-up
Secondary outcomes (1)
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.
Measured: 12-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start3 Jan 2025
- Primary completion24 Apr 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental ImplantsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swiss Dental Solutions
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Etyene Schnurr, DMD PhD DSc MSc, Study director, Vizstara Professional Education, Clinical and R & D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06314425
- Sponsor's protocol ID
- IRB_20240714
- Acronym
- SDS
- Status last verified
- Jul 2026
- First submitted
- 7 Mar 2024
- Last updated
- 31 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schnurr E, Parra M, Bauder R, Schick F, Langwieder B, Nischwitz D, Rutkowski JL. Patient Perspectives on Immediate Zirconia Implant Therapy: Results from a Long-term Multicenter European Study. J Oral Implantol. 2025 Nov 12;51(5):444-453. doi: 10.1563/aaid-joi-D-25-00111.
PubMed 40566728
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Series With Zirconia Implants
- ClinicalTrials.gov ID
- NCT06314425
- Acronym / sponsor ID
- SDS / IRB_20240714
- Conditions
- Dental Implants, Ceramic Implant
- Keywords
- ceramic implants, titanium implants, peri-implantitis, marginal bone loss, soft tissue, bone augmentation, immediate implantation, dental implants
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Swiss Dental SolutionsIndustry (pharma, biotech, devices)
- Study start
- 3 Jan 2025 (actual)
- Primary completion
- 24 Apr 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 18 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Immediate loading of ceramic implants | Experimental | Procedure: Immediate dental implants placements on fresh sockets after tooth extractionTooth/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 may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Immediate dental implants placements on fresh sockets after tooth extractionZirconia 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. | Procedure or surgery | Immediate loading of ceramic implants |
Primary outcome
Cumulative Survival Rate (CSR)
Time frame: 12-month follow-up
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.
1 secondary outcome
Marginal Bone Loss (MBL)
Time frame: 12-month follow-up
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
- Background: PubMed 40566728Schnurr E, Parra M, Bauder R, Schick F, Langwieder B, Nischwitz D, Rutkowski JL. Patient Perspectives on Immediate Zirconia Implant Therapy: Results from a Long-term Multicenter European Study. J Oral Implantol. 2025 Nov 12;51(5):444-453. doi: 10.1563/aaid-joi-D-25-00111.
- Individual participant dataSharing planned: No
Related trials for Dental Implants
Active, not recruitingObservational study
Long-Term Stability of Soft and Hard Tissues After Guided Bone Regeneration in the Maxillary Anterior Region
Alveolar Bone Deficiency
Recruiting
Multi-Evaluation of Dental Abutments With Different Surfaces
Edentulism, Dental Implant
Recruiting
Evaluation of Different Grafting Technique of Thin Gingival Phenotype With Delayed Dental Implants
Implant Dentistry, Connective Tissue Graft
Not yet recruiting
Comparative Evaluation of Artificial Intelligence-Assisted Versus Conventional Guided Implant Planning in Free End Saddle Cases
Partial Edentulism Class 1 or Class 2
Recruiting
Clinical Performance of Dual-cantilevered Single-implant Bridge
Dental Implant Failed
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Etyene Schnurr, DMD PhD DSc MSc study director
Vizstara Professional Education, Clinical and R & D
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate dental implants placements on fresh sockets after tooth extraction in people with Dental Implants and Ceramic Implant, run by Swiss Dental Solutions at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative Survival Rate (CSR) (time frame: 12-month follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06314425, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.