Jaw, EdentulousNCT05355792
Multicenter Study to Evaluate the Clinical Outcome of the OmniTaper EV Implant in Single Tooth Restorations
A study testing OmniTaper EV implants in people with Jaw, Edentulous, run by Dentsply Sirona Implants and Consumables at 6 sites in 3 countries.
Trial summary
This clinical study, funded by the company Dentsply Sirona, is being carried out to see if the newly developed tooth implant "OmniTaper EV" is safe, effective and functions as intended when replacing a lost or removed tooth. The OmniTaper EV implant is a further development of existing dental implants. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Jaw, Edentulous
- What is being tested?
- OmniTaper EV implants
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 139 participants
- Where
- 6 sitesin 3 countries
- Study dates
- 22 Sep 2022to 31 Jan 2029
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 (2nd and 3rd molars are excluded), and each subject can only receive one implant.
- Deemed by the PI/Subinvestigator 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 PI's/Subinvestigator's judgement.
- Unable or unwilling to return for follow-up visits for a period of 5 years.
- Severe non-compliance to CIP as judged by the PI/Subinvestigator and/or Dentsply Sirona.
- 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.
Show all 30Show fewer
- Uncontrolled para-functional habits, e.g. bruxism.
- 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, prior or current use of oral or intravenous bisphosphonate, 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 /Not applicable for UK).
- 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 (as reported by the subject).
- 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 personnel 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
6 sites in 3 countries.
6 sites in 3 countries
Germany3 sites
Praxis Prof. Dr. Dhom & Kollegen MVZ GmbH
Ludwigshafen, DE-67059
Private Clinic Schloss Schellenstein
Olsberg, DE-59939
Kornmann Gerlach & Kollegen
Oppenheim, DE-55276
United Kingdom2 sites
Birmingham Dental Hospital
Birmingham, West Midlands, B5 7EG
The Implant Experts
Maidstone, Kent, ME14 5BJ
Switzerland1 site
Dr. med. dent. Alessandro Hellmuth Ponte
Lugano, CH-6900
About this study
Official title: Clinical Investigation Title: An Open, Prospective, Multicenter Investigation to Evaluate the Clinical Outcome of OmniTaper EV Implants in Extraction Sockets and Healed Ridges - A 5-year Follow-up
This clinical study, funded by the company Dentsply Sirona, is being carried out to see if the newly developed tooth implant "OmniTaper EV" is safe, effective and functions as intended when replacing a lost or removed tooth. The OmniTaper EV implant is a further development of existing dental implants. It is made of titanium, a metal that is well tolerated by the human body, which has been successfully used in dental implants for more than 40 years. All components used in this study are available on the market, are CE-marked and will be used according to intended use and approved instructions.
The study involves at 11 planned clinic visits including follow-up visits 6 months and annually until 5 years after installation of the permanent crown. after over a period of about five and a half years. The treatment method and healing period may vary depending on the individual case and treatment plan and additional visits may therefore need to be scheduled. The visits and procedures are the same as standard of care and no procedures will be done just for purpose of research.
The study aims to recruit about 137 men and women from six clinics across Europe (Germany, UK and Switzerland) and participants can only receive one study implant each. Participation is entirely voluntary and participants can choose to withdraw from the study at any time, without giving a reason. The decision to decline or withdraw participation will not affect participants future treatment or care
- Conditions
- Jaw, Edentulous
- Being tested
- OmniTaper EV implants
- Keywords
- Partially
- Medical subject headings
- Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OmniTaper EV implantsDevice
Also called OmniTaper EV implants UDI 0739253224012WR
Partially edentulous subjects in need of one implant in the maxilla or mandible (2nd and 3rd molars excluded) will receive an OmniTaper EV implant system. The study will be done in accordance with standard dental practice using a one- or two-stage surgical protocol and immediate or delayed placement and/or loading.
| 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 an OmniTaper EV implant system available in the following sizes: diameter 3.4, 3.8, 4.5 and 5.5 mm and lengths 8, 9.5, 11, 13, 15 and 18 mm. Receives: Device: OmniTaper EV implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant survival rate 1 year after permanent restoration by counting implant in place 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: 1 year after permanent restoration (which is estimated to occur approximately 3 months after implant placement).
Secondary outcomes (12)
Implant survival rate at 3 and 5 years after permanent restoration by counting implant in place.
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: 3 and 5 year after permanent restoration (which is estimated to occur approximately 3 months after implant placement).
Change of implant stability quotient value (ISQ) between implant placement and permanent restoration.
Implant stability will be evaluated by 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 (which is estimated to occur approximately 1 month after enrollment).
Final and maximum insertion torque value for each implant at implant placement.
Final and maximum insertion torque value (ITV), based on ITV curve, measured in Ncm.
Measured: At date of implant placement (which is estimated to occur approximately 1 month after enrollment).
Surgeon's assessment of implant stability and confidence at implant placement for each implant.
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". Each statement will be evaluated separately.
Measured: Immediately after implant placement (which is estimated to occur approximately 1 month after enrollment).
Implant success, i.e., number of implants documented as successful at 1, 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 after permanent restoration (which is estimated to occur approximately 3 months after implant placement).
Maintenance of marginal bone levels (MBL).
The MBL change from permanent restoration compared to 1, 3, and 5 years. MBLs will be determined from X-rays, 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 (which is estimated to occur approximately 3 months after implant placement) and at 1, 3 and 5 years after PR..
PPD (Probing Pocket Depth)
PPD will be evaluated at four surfaces around the implant (mesial, distal, buccal and lingual), by using a periodontal probe. The distance from the mucosal margin to the bottom of the probe-able pocket will be measured in millimeter. PPD mean values will be calculated on an implant level for each visit. Changes over time will be analyzed.
Measured: At PR (which is estimated to occur approximately 3 months after implant placement) and at 1, 2, 3, 4 and 5 years after PR.
Bleeding on Probing (BoP)
BoP will be evaluated at four surfaces around the implant (mesial, distal, buccal and lingual), by using a periodontal probe. Bleeding will be recorded as presence or absence of bleeding when probing to the bottom of the pocket. The proportion of surfaces with presence of bleeding will be calculated and presented on an implant level for each visit.
Measured: At PR (which is estimated to occur approximately 3 months after implant placement) and at 1, 2, 3, 4 and 5 years after PR.
Plaque
Plaque will be recorded as presence or absence of plaque by visual inspection on four surfaces at each implant site.The proportion of surfaces with presence of plaque will be calculated and presented on an implant level for each visit.
Measured: 6 months, 1, 2, 3, 4 and 5 years after PR (which is estimated to occur approximately 3 months after implant placement).
Occurrence of Adverse Events (AEs)
Continuously collected and reported AEs at each investigation visit from implant placement.
Measured: From date of implant placement (which is estimated to occur approximately 1 month after enrollment) up to 5 years after permanent restoration (which is estimated to occur approximately 3 months after implant placement).
Occurrence of Adverse Device Effects (ADEs)
Continuously collected and reported ADEs at each investigation visit from implant placement.
Measured: From date of implant placement (which is estimated to occur approximately 1 month after enrollment) up to 5 years after permanent restoration (which is estimated to occur approximately 3 months after implant placement).
Occurrence of Device Deficiencies (DDs)
Continuously collected and reported DDs at each investigation visit from implant placement.
Measured: From date of implant placement (which is estimated to occur approximately 1 month after enrollment) up to 5 years after permanent restoration (which is estimated to occur approximately 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 posted2 May 2022
- Study start22 Sep 2022
- Primary completion30 Nov 2028 (estimated)
- Study completion31 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Jaw, EdentulousStudies 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
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dentsply Sirona Implants and Consumables
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Gehrke, Dr, Principal investigator, Praxis Prof. Dr. Dhom & Kollegen MVZ GmbH Bismarckstraße, Ludwigshafen, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05355792
- Sponsor's protocol ID
- C-OM-21-002
- Status last verified
- Feb 2026
- First submitted
- 20 Apr 2022
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation Title: An Open, Prospective, Multicenter Investigation to Evaluate the Clinical Outcome of OmniTaper EV Implants in Extraction Sockets and Healed Ridges - A 5-year Follow-up
- ClinicalTrials.gov ID
- NCT05355792
- Acronym / sponsor ID
- C-OM-21-002
- Conditions
- Jaw, Edentulous
- Keywords
- Partially
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Dentsply Sirona Implants and ConsumablesIndustry (pharma, biotech, devices)
- Study start
- 22 Sep 2022 (actual)
- Primary completion
- 30 Nov 2028 (estimated)
- Study completion
- 31 Jan 2029 (estimated)
- First posted
- 2 May 2022 (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 clinical study, funded by the company Dentsply Sirona, is being carried out to see if the newly developed tooth implant "OmniTaper EV" is safe, effective and functions as intended when replacing a lost or removed tooth. The OmniTaper EV implant is a further development of existing dental implants. It is made of titanium, a metal that is well tolerated by the human body, which has been successfully used in dental implants for more than 40 years. All components used in this study are available on the market, are CE-marked and will be used according to intended use and approved instructions.
The study involves at 11 planned clinic visits including follow-up visits 6 months and annually until 5 years after installation of the permanent crown. after over a period of about five and a half years. The treatment method and healing period may vary depending on the individual case and treatment plan and additional visits may therefore need to be scheduled. The visits and procedures are the same as standard of care and no procedures will be done just for purpose of research.
The study aims to recruit about 137 men and women from six clinics across Europe (Germany, UK and Switzerland) and participants can only receive one study implant each. Participation is entirely voluntary and participants can choose to withdraw from the study at any time, without giving a reason. The decision to decline or withdraw participation will not affect participants future treatment or care
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: OmniTaper EV implantsA single, open-label group with patients in need of single tooth restorations will receive an OmniTaper EV implant system available in the following sizes: diameter 3.4, 3.8, 4.5 and 5.5 mm and lengths 8, 9.5, 11, 13, 15 and 18 mm. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 (2nd and 3rd molars are excluded), and each subject can only receive one implant.
- Deemed by the PI/Subinvestigator 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
Key exclusion criteria (30 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 PI's/Subinvestigator's judgement.
- Unable or unwilling to return for follow-up visits for a period of 5 years.
- Severe non-compliance to CIP as judged by the PI/Subinvestigator and/or Dentsply Sirona.
- Known allergy or hypersensitivity to titanium and/or stainless steel.
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 |
|---|---|---|
| OmniTaper EV implantsAlso: OmniTaper EV implants UDI 0739253224012WRPartially edentulous subjects in need of one implant in the maxilla or mandible (2nd and 3rd molars excluded) will receive an OmniTaper EV implant system. The study will be done in accordance with standard dental practice using a one- or two-stage surgical protocol and immediate or delayed placement and/or loading. | Device | Single tooth restorations |
Primary outcome
Implant survival rate 1 year after permanent restoration by counting implant in place 1 year after permanent restoration
Time frame: 1 year after permanent restoration (which is estimated to occur approximately 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.
12 secondary outcomes
Implant survival rate at 3 and 5 years after permanent restoration by counting implant in place.
Time frame: 3 and 5 year after permanent restoration (which is estimated to occur approximately 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 (which is estimated to occur approximately 1 month after enrollment).
Final and maximum insertion torque value for each implant at implant placement.
Time frame: At date of implant placement (which is estimated to occur approximately 1 month after enrollment).
Surgeon's assessment of implant stability and confidence at implant placement for each implant.
Time frame: Immediately after implant placement (which is estimated to occur approximately 1 month after enrollment).
Implant success, i.e., number of implants documented as successful at 1, 3 and 5 years after permanent restoration.
Time frame: 1, 2, 3 and 5 years after permanent restoration (which is estimated to occur approximately 3 months after implant placement).
Maintenance of marginal bone levels (MBL).
Time frame: At permanent restoration (which is estimated to occur approximately 3 months after implant placement) and at 1, 3 and 5 years after PR..
PPD (Probing Pocket Depth)
Time frame: At PR (which is estimated to occur approximately 3 months after implant placement) and at 1, 2, 3, 4 and 5 years after PR.
Bleeding on Probing (BoP)
Time frame: At PR (which is estimated to occur approximately 3 months after implant placement) and at 1, 2, 3, 4 and 5 years after PR.
Plaque
Time frame: 6 months, 1, 2, 3, 4 and 5 years after PR (which is estimated to occur approximately 3 months after implant placement).
Occurrence of Adverse Events (AEs)
Time frame: From date of implant placement (which is estimated to occur approximately 1 month after enrollment) up to 5 years after permanent restoration (which is estimated to occur approximately 3 months after implant placement).
Occurrence of Adverse Device Effects (ADEs)
Time frame: From date of implant placement (which is estimated to occur approximately 1 month after enrollment) up to 5 years after permanent restoration (which is estimated to occur approximately 3 months after implant placement).
Occurrence of Device Deficiencies (DDs)
Time frame: From date of implant placement (which is estimated to occur approximately 1 month after enrollment) up to 5 years after permanent restoration (which is estimated to occur approximately 3 months after implant placement).
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 17 Feb 2026.
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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.
Peter Gehrke, Dr principal investigator
Praxis Prof. Dr. Dhom & Kollegen MVZ GmbH Bismarckstraße, Ludwigshafen, Germany
6 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OmniTaper EV implants in people with Jaw, Edentulous, run by Dentsply Sirona Implants and Consumables at 6 sites in 3 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 5 inclusion and 30 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 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany, United Kingdom, Switzerland. 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?
Implant survival rate 1 year after permanent restoration by counting implant in place 1 year after permanent restoration (time frame: 1 year after permanent restoration (which is estimated to occur approximately 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 17 Feb 2026.