Clinical trial NCT05355792: Multicenter Study to Evaluate the Clinical Outcome of the OmniTaper EV Implant in Single Tooth Restorations
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Jaw, Edentulous
Keywords: Partially
Lead sponsor: Dentsply Sirona Implants and Consumables
Sponsor class: INDUSTRY
First posted: 2022-05-02
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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. 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


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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.
* 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.

Primary outcomes:
measure: Implant survival rate 1 year after permanent restoration by counting implant in place 1 year after permanent restoration
timeFrame: 1 year after permanent restoration (which is estimated to occur approximately 3 months after implant placement).
Secondary outcomes:
measure: Implant survival rate at 3 and 5 years after permanent restoration by counting implant in place.
timeFrame: 3 and 5 year after permanent restoration (which is estimated to occur approximately 3 months after implant placement).
measure: Change of implant stability quotient value (ISQ) between implant placement and permanent restoration.
timeFrame: From date of implant placement (which is estimated to occur approximately 1 month after enrollment).
measure: Final and maximum insertion torque value for each implant at implant placement.
timeFrame: At date of implant placement (which is estimated to occur approximately 1 month after enrollment).
measure: Surgeon's assessment of implant stability and confidence at implant placement for each implant.
timeFrame: Immediately after implant placement (which is estimated to occur approximately 1 month after enrollment).
measure: Implant success, i.e., number of implants documented as successful at 1, 3 and 5 years after permanent restoration.
timeFrame: 1, 2, 3 and 5 years after permanent restoration (which is estimated to occur approximately 3 months after implant placement).
measure: Maintenance of marginal bone levels (MBL).
timeFrame: At permanent restoration (which is estimated to occur approximately 3 months after implant placement) and at 1, 3 and 5 years after PR..
measure: PPD (Probing Pocket Depth)
timeFrame: At PR (which is estimated to occur approximately 3 months after implant placement) and at 1, 2, 3, 4 and 5 years after PR.
measure: Bleeding on Probing (BoP)
timeFrame: At PR (which is estimated to occur approximately 3 months after implant placement) and at 1, 2, 3, 4 and 5 years after PR.
measure: Plaque
timeFrame: 6 months, 1, 2, 3, 4 and 5 years after PR (which is estimated to occur approximately 3 months after implant placement).
measure: Occurrence of Adverse Events (AEs)
timeFrame: 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).
measure: Occurrence of Adverse Device Effects (ADEs)
timeFrame: 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).
measure: Occurrence of Device Deficiencies (DDs)
timeFrame: 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).
Other outcomes:
Locations:
city: Ludwigshafen
country: Germany
facility: Praxis Prof. Dr. Dhom & Kollegen MVZ GmbH
city: Olsberg
country: Germany
facility: Private Clinic Schloss Schellenstein
city: Oppenheim
country: Germany
facility: Kornmann Gerlach & Kollegen
city: Lugano
country: Switzerland
facility: Dr. med. dent. Alessandro Hellmuth Ponte
city: Maidstone
country: United Kingdom
facility: The Implant Experts
state: Kent
city: Birmingham
country: United Kingdom
facility: Birmingham Dental Hospital
state: West Midlands
Study officials:
affiliation: Praxis Prof. Dr. Dhom & Kollegen MVZ GmbH Bismarckstraße, Ludwigshafen, Germany
name: Peter Gehrke, Dr
role: PRINCIPAL_INVESTIGATOR
References: