Jaw, Edentulous, PartiallyNCT05315414
Multicenter Study to Evaluate the Clinical Outcome of PrimeTaper EV Implant in Single Tooth Restorations
A study testing PrimeTaper EV implant in people with Jaw, Edentulous, Partially, run by Dentsply Sirona Implants and Consumables at 5 sites in 5 countries.
Trial summary
The purpose of this study is to evaluate the clinical outcome of implant survival of the PrimeTaper EV implant in single tooth restorations 1 year after permanent restoration. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Jaw, Edentulous, Partially
- What is being tested?
- PrimeTaper EV implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 3 May 2022to May 2029
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult aged 18-75 years.
- Willing and able to sign and date the informed consent form.
- In need of an implant in position 16 to 26 or 36 to 46, and each subject can only receive one implant.
- Deemed by the investigator as likely to present with an initially stable implant situation.
- A stable occlusion, i.e. an opposing natural dentition, a crown, an implant-supported fixed or removable prosthesis, a partial removable prosthesis or a full denture.
- An adjacent tooth (root with natural or artificial crown) or an implant-supported crown mesially and distally. Exemption: If the planned implant is in the first molar position, an edentulous space is accepted distally
Who cannot join
- Not willing to participate in the clinical investigation or not able to understand the content of the clinical investigation.
- Unlikely to be able to comply with clinical investigation procedures according to investigator's judgement.
- Unable or unwilling to return for follow-up visits for a period of 5 years.
- Known allergy or hypersensitivity to titanium and/or stainless steel.
- Uncontrolled pathological process in the oral cavity, e.g. untreated rampant caries and uncontrolled periodontal disease.
- Uncontrolled para-functional habits, e.g. bruxism.
Show all 29Show fewer
- Current need of any Guided Bone Regeneration (GBR) procedure in the planned implant area (gap filling at immediate placement and soft tissue grafting are allowed).
- Systemic or local disease or condition that would compromise post-operative healing and/ or osseointegration.
- Immunosuppression, use of corticosteroids, per-os or intravenous bisphosphonate use, or any other medication such as anti-resorptive therapy or monoclonal antibodies that could compromise post-operative healing and/or osseointegration.
- Any other condition that would make the subject unsuitable for participation, including but not limited to;
- History of radiation therapy in the head and neck region.
- History of chemotherapy within 5 years prior to surgery.
- Present alcohol and/or drug abuse.
- Ongoing psychiatric illness.
- Current smoking/use of tobacco, including e-cigarettes.
- Any ongoing disease that would make the subject unsuitable for participation, including but not limited to;
- Recent myocardial infarction (< 3 months*).
- Recent cerebrovascular accident (< 3 months*).
- Recent cardiac-valvular prosthesis placement (< 3 months*).
- Hemorrhagic diathesis.
- Severe liver dysfunction.
- Known or suspected current malignancy.
- Uncontrolled diabetes mellitus.
- Florid infection.
- Pregnant or breastfeeding females. (Pregnancy tests will be performed as per local requirements).
- Previous enrolment in the present clinical investigation.
- Involvement in the planning and conduct of the clinical investigation (applies to both Dentsply Sirona staff and the clinical investigation site).
- Simultaneous participation in another clinical investigation, or participation in a clinical investigation during the last 6 months that may interfere with the present clinical investigation.
- < 3 months is a strict exclusion criterion. After 3 month it is up to the investigator to judge whether the subject is considered suitable for participation or not.
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
About this study
Official title: An Open, Prospective, Multicenter Investigation to Evaluate the Clinical Outcome of PrimeTaper EV Implant in Extraction Sockets and Healed Ridges - A 5 Year Follow-up
The purpose of this study is to evaluate the clinical outcome of implant survival of the PrimeTaper EV implant in single tooth restorations 1 year after permanent restoration.
- Conditions
- Jaw, Edentulous, Partially
- Being tested
- PrimeTaper EV implant
- Medical subject headings
- Jaw, Edentulous, Partially
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PrimeTaper EV implantDevice
Tapered dental implant developed by Dentsply Sirona
| Study group | Role | What they receive |
|---|---|---|
| Single tooth restorations | Experimental | A single, open-label group with patients in need of single tooth restorations will receive PrimeTaper EV implant system with diameters 3.6, 4.2, 4.8, 5.4 mm, and lengths 6.5, 8, 9, 11, 13, 15 and 17 mm. Receives: Device: PrimeTaper EV implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant Survival, i.e. Number of Implants in Place Counted Clinically, 1 Year After Permanent Restoration.
Implant survival rate is a binary variable evaluated clinically, i.e. 'Yes' or 'No' where 'Yes' means that the implant is still in place and 'No' means that the implant is not in place. Any implant that has been removed or lost after implant placement visit will be considered a failure, whatever the reason for removal/loss.
Measured: One year post permanent restoration (anticipated average 3 months after implant placement).
Secondary outcomes (11)
Implant Survival, i.e. Number of Implants in Place Counted Clinically, 2, 3, 4 and 5 Years After Permanent Restoration.
Implant survival rate is a binary variable evaluated clinically, i.e. 'Yes' or 'No' where 'Yes' means that the implant is still in place and 'No' means that the implant is not in place. Any implant that has been removed or lost after implant placement visit will be considered a failure, whatever the reason for removal/loss.
Measured: 2, 3, 4 and 5 years post permanent restoration (anticipated average 3 months after implant placement).
Change of Implant Stability Quotient Value (ISQ) Between Implant Placement and Permanent Restoration.
Implant stability will be evaluated through ISQ value using Resonance Frequency Analysis (RFA). The stability is presented as an ISQ value. The higher the ISQ value the higher the stability. Recorded as a numeric value (1-100).
Measured: From date of implant placement (anticipated average 1 month after inclusion) to date of permanent restoration (anticipated average 3 months after implant placement).
Maximum Insertion Torque Value for Each Implant at Implant Placement.
Maximum insertion torque value (ITV), based on ITV curve, measured in Ncm.
Measured: At date of implant placement (anticipated average 1 month after inclusion).
Final Insertion Torque Value for Each Implant at Implant Placement.
Final insertion torque value (ITV), based on ITV curve, measured in Ncm.
Measured: At date of implant placement (anticipated average 1 month after inclusion).
Investigator Questionnaire for Each Investigational Medical Device After Implant Placement.
Numerical scale 1-10, where 1 = totally disagree with the statement, and 10 = totally agree with the statement. Statements to be evaluated by the surgeon: "The implant was guided into the prepared osteotomy", "The implant followed the prepared osteotomy", "The implant has a good primary stability", "The drilling protocol is easy to use", "The implant has efficient cutting properties". Each statement will be evaluated separately.
Measured: Immediately after implant placement (anticipated average 1 month after inclusion).
Implant Success, i.e., Number of Implants Documented as Successful at 1, 2, 3 and 5 Years After Permanent Restoration.
Successful implants counted, i.e. 'Yes' or 'No'. An implant will be considered successful if all of the following criteria are fulfilled:
- Implant in place.
- Lack of evidence of peri-implant radiolucency in X-ray.
- Less than 1mm vertical bone loss during first year after loading with permanent restoration and 0,2mm annually thereafter.
- Absence of persistent and/or irreversible signs and symptoms such as pain, infections, neuropathies, paresthesia, or violation of the mandibular canal.
Measured: 1, 2, 3 and 5 years post permanent restoration (anticipated average 3 months after implant placement).
Change of Marginal Bone Level up to 5 Years Post Permanent Restoration Compared to Permanent Restoration.
MBL changes determined from radiographs, expressed as the distance from the implant reference point to the most coronal bone-to-implant contact on the mesial and distal side of the implant. The average will be calculated and compared for each evaluation period.
Measured: At permanent restoration (anticipated average 3 months after implant placement) and 1, 2, 3 and 5 years post permanent restoration.
Change of Probing Pocket Depth (PPD) in mm Between Permanent Restoration, and 6 Months, 1, 2, 3, 4 and 5 Years After Permanent Restoration.
Probing Pocket Depth (PPD) measured as the distance from the mucosal margin to the bottom of the probe-able pocket in mm.
Measured: At permanent restoration (anticipated average 3 months after implant placement) and 6 months, 1, 2, 3, 4 and 5 years post permanent restoration.
Presence of Bleeding on Probing (BoP), at Permanent Restoration, and 6 Months, 1, 2, 3, 4 and 5 Years After Permanent Restoration.
Bleeding on Probing (BoP) recorded as presence or absence of bleeding when probing to the bottom of the pocket.
Measured: At permanent restoration (anticipated average 3 months after implant placement) and 6 months, 1, 2, 3, 4 and 5 years post permanent restoration.
Presence of Plaque at 6 Months, 1, 2, 3, 4 and 5 Years After Permanent Restoration.
Plaque recorded as presence or absence of plaque by visual inspection on four surfaces at each implant site.
Measured: 6 months, 1, 2, 3, 4 and 5 years post permanent restoration (anticipated average 3 months after implant placement).
Occurrence of Adverse Events, Adverse Device Effects, and Device Deficiencies During the Clinical Investigation.
Adverse Events, Adverse Device Effects, and Device Deficiencies spontaneously reported, and collection at each clinical investigation visit.
Measured: Up to 5 years after permanent restoration (anticipated average 3 months after implant placement).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2022
- Study start3 May 2022
- Primary completion12 Mar 2025
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Jaw, Edentulous, PartiallyStudies 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
- 138 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dentsply Sirona Implants and Consumables
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Andy Temmerman, Prof., Principal investigator, KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05315414
- Sponsor's protocol ID
- C-PT-21-001
- Status last verified
- Sep 2026
- First submitted
- 16 Mar 2022
- Last updated
- 6 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open, Prospective, Multicenter Investigation to Evaluate the Clinical Outcome of PrimeTaper EV Implant in Extraction Sockets and Healed Ridges - A 5 Year Follow-up
- ClinicalTrials.gov ID
- NCT05315414
- Acronym / sponsor ID
- C-PT-21-001
- Conditions
- Jaw, Edentulous, Partially
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 138 participants (actual)
- Lead sponsor
- Dentsply Sirona Implants and ConsumablesIndustry (pharma, biotech, devices)
- Study start
- 3 May 2022 (actual)
- Primary completion
- 12 Mar 2025 (actual)
- Study completion
- May 2029 (estimated)
- First posted
- 7 Apr 2022 (actual)
- Results
- Posted 6 Oct 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the clinical outcome of implant survival of the PrimeTaper EV implant in single tooth restorations 1 year after permanent restoration.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single tooth restorations | Experimental | Device: PrimeTaper EV implantA single, open-label group with patients in need of single tooth restorations will receive PrimeTaper EV implant system with diameters 3.6, 4.2, 4.8, 5.4 mm, and lengths 6.5, 8, 9, 11, 13, 15 and 17 mm. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult aged 18-75 years.
- Willing and able to sign and date the informed consent form.
- In need of an implant in position 16 to 26 or 36 to 46, and each subject can only receive one implant.
- Deemed by the investigator as likely to present with an initially stable implant situation.
- A stable occlusion, i.e. an opposing natural dentition, a crown, an implant-supported fixed or removable prosthesis, a partial removable prosthesis or a full denture.
Key exclusion criteria (29 listed)
- Not willing to participate in the clinical investigation or not able to understand the content of the clinical investigation.
- Unlikely to be able to comply with clinical investigation procedures according to investigator's judgement.
- Unable or unwilling to return for follow-up visits for a period of 5 years.
- Known allergy or hypersensitivity to titanium and/or stainless steel.
- Uncontrolled pathological process in the oral cavity, e.g. untreated rampant caries and uncontrolled periodontal disease.
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 |
|---|---|---|
| PrimeTaper EV implantTapered dental implant developed by Dentsply Sirona | Device | Single tooth restorations |
Primary outcome
Implant Survival, i.e. Number of Implants in Place Counted Clinically, 1 Year After Permanent Restoration.
Time frame: One year post permanent restoration (anticipated average 3 months after implant placement).
Implant survival rate is a binary variable evaluated clinically, i.e. 'Yes' or 'No' where 'Yes' means that the implant is still in place and 'No' means that the implant is not in place. Any implant that has been removed or lost after implant placement visit will be considered a failure, whatever the reason for removal/loss.
11 secondary outcomes
Implant Survival, i.e. Number of Implants in Place Counted Clinically, 2, 3, 4 and 5 Years After Permanent Restoration.
Time frame: 2, 3, 4 and 5 years post permanent restoration (anticipated average 3 months after implant placement).
Change of Implant Stability Quotient Value (ISQ) Between Implant Placement and Permanent Restoration.
Time frame: From date of implant placement (anticipated average 1 month after inclusion) to date of permanent restoration (anticipated average 3 months after implant placement).
Maximum Insertion Torque Value for Each Implant at Implant Placement.
Time frame: At date of implant placement (anticipated average 1 month after inclusion).
Final Insertion Torque Value for Each Implant at Implant Placement.
Time frame: At date of implant placement (anticipated average 1 month after inclusion).
Investigator Questionnaire for Each Investigational Medical Device After Implant Placement.
Time frame: Immediately after implant placement (anticipated average 1 month after inclusion).
Implant Success, i.e., Number of Implants Documented as Successful at 1, 2, 3 and 5 Years After Permanent Restoration.
Time frame: 1, 2, 3 and 5 years post permanent restoration (anticipated average 3 months after implant placement).
Change of Marginal Bone Level up to 5 Years Post Permanent Restoration Compared to Permanent Restoration.
Time frame: At permanent restoration (anticipated average 3 months after implant placement) and 1, 2, 3 and 5 years post permanent restoration.
Change of Probing Pocket Depth (PPD) in mm Between Permanent Restoration, and 6 Months, 1, 2, 3, 4 and 5 Years After Permanent Restoration.
Time frame: At permanent restoration (anticipated average 3 months after implant placement) and 6 months, 1, 2, 3, 4 and 5 years post permanent restoration.
Presence of Bleeding on Probing (BoP), at Permanent Restoration, and 6 Months, 1, 2, 3, 4 and 5 Years After Permanent Restoration.
Time frame: At permanent restoration (anticipated average 3 months after implant placement) and 6 months, 1, 2, 3, 4 and 5 years post permanent restoration.
Presence of Plaque at 6 Months, 1, 2, 3, 4 and 5 Years After Permanent Restoration.
Time frame: 6 months, 1, 2, 3, 4 and 5 years post permanent restoration (anticipated average 3 months after implant placement).
Occurrence of Adverse Events, Adverse Device Effects, and Device Deficiencies During the Clinical Investigation.
Time frame: Up to 5 years after permanent restoration (anticipated average 3 months after implant placement).
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Andy Temmerman, Prof. principal investigator
KU Leuven
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PrimeTaper EV implant in people with Jaw, Edentulous, Partially, run by Dentsply Sirona Implants and Consumables at 5 sites in 5 countries.
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 6 inclusion and 29 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 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Belgium, Germany, Italy, Netherlands. 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?
Yes. Results are posted in the registry (first posted 6 Oct 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Implant Survival, i.e. Number of Implants in Place Counted Clinically, 1 Year After Permanent Restoration. (time frame: One year post permanent restoration (anticipated average 3 months after implant placement).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Oct 2026.