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

NCT ID: NCT05315414

Last Updated: 2025-08-28

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 138 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-03
• Study Completion Date: 2029-05-31

Brief 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.

Conditions

Jaw, Edentulous, Partially

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single tooth restorations

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.

Group Type: EXPERIMENTAL

PrimeTaper EV implant

Intervention Type: DEVICE

Tapered dental implant developed by Dentsply Sirona

Interventions

PrimeTaper EV implant

Tapered dental implant developed by Dentsply Sirona

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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

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 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.
• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dentsply Sirona Implants and Consumables

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Andy Temmerman, Prof.

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

University of Iowa

Iowa City, Iowa, United States

Catholic University of Leuven

Leuven, , Belgium

Dental practice Dr Mischa Krebs

Alzey, , Germany

Studio Toia

Busto Arsizio, , Italy

Dr.F.L.Guljé, De Mondhoek

Apeldoorn, , Netherlands

Countries

United States; Belgium; Germany; Italy; Netherlands

Other Identifiers

C-PT-21-001

Identifier Type: -

Identifier Source: org_study_id

NCT05387421

Identifier Type: -

Identifier Source: nct_alias