Multicenter Study to Evaluate the Clinical Outcome of the OmniTaper EV Implant in Single Tooth Restorations

NCT05355792 | Active Not Recruiting

• 1 other identifier: C-OM-21-002
• Study Type: interventional
• Target: 139
• Locations: 3 countries
• Sites: 6

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

Conditions

Jaw, Edentulous

Keywords

Partially

Outcome Measures

Primary Outcomes (1)

• 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.

  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.

  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.

  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.

  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.

  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.

  1, 2, 3 and 5 years after permanent restoration (which is estimated to occur approximately 3 months after implant placement).

Study Arms (1)

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.

Device: OmniTaper EV implants

Interventions

OmniTaper EV implants DEVICE

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.

Also known as: OmniTaper EV implants UDI 0739253224012WR

Single tooth restorations

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dentsply Sirona Implants and Consumables: lead

Study Sites (6)

Praxis Prof. Dr. Dhom & Kollegen MVZ GmbH

Ludwigshafen, DE-67059, Germany

Location

Private Clinic Schloss Schellenstein

Olsberg, DE-59939, Germany

Location

Kornmann Gerlach & Kollegen

Oppenheim, DE-55276, Germany

Location

Dr. med. dent. Alessandro Hellmuth Ponte

Lugano, CH-6900, Switzerland

Location

The Implant Experts

Maidstone, Kent, ME14 5BJ, United Kingdom

Location

Birmingham Dental Hospital

Birmingham, West Midlands, B5 7EG, United Kingdom

Location

MeSH Terms

Conditions

Jaw, Edentulous

Condition Hierarchy (Ancestors)

Jaw Diseases; Musculoskeletal Diseases; Stomatognathic Diseases; Mouth, Edentulous; Mouth Diseases; Tooth Diseases

Study Officials

• Peter Gehrke, Dr

  Praxis Prof. Dr. Dhom & Kollegen MVZ GmbH Bismarckstraße, Ludwigshafen, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 20, 2022
• First Posted: May 2, 2022
• Study Start: September 22, 2022
• Primary Completion (Estimated): November 30, 2028
• Study Completion (Estimated): January 31, 2029
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

GB (2); DE (3); CH (1)