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

Dentsply

Status: Active, not recruiting

Conditions: Jaw, Edentulous, Partially

Treatments: Device: PrimeTaper EV implant

Study type: Interventional

Funder types: Industry

Identifiers

NCT05315414

C-PT-21-001

Details and patient eligibility

About

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.

Enrollment: 138 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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138 participants in 1 patient group

Single tooth restorations

Experimental group

Description:

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.

Treatment:

Device: PrimeTaper EV implant