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

NCT05315414 | Active Not Recruiting FDA Device

• 1 other identifier: C-PT-21-001
• Study Type: interventional
• Target: 138
• Locations: 5 countries
• Sites: 5

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

Outcome Measures

Primary Outcomes (1)

• Implant survival, i.e. number of implants in place counted clinically, 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.

  One year post permanent restoration (anticipated average 3 months after implant placement).

Secondary Outcomes (11)

• Implant survival, i.e. number of implants in place counted clinically, 2, 3, 4 and 5 years after permanent restoration.

  2, 3, 4 and 5 years post permanent restoration (anticipated average 3 months after implant placement).

• Change of implant stability quotient value (ISQ) between implant placement and permanent restoration.

  From date of implant placement (anticipated average 1 month after inclusion) to date of permanent restoration (anticipated average 3 months after implant placement).

• Maximum insertion torque value for each implant at implant placement.

  At date of implant placement (anticipated average 1 month after inclusion).

• Final insertion torque value for each implant at implant placement.

  At date of implant placement (anticipated average 1 month after inclusion).

• Investigator questionnaire for each investigational medical device after implant placement.

  Immediately after implant placement (anticipated average 1 month after inclusion).

Study Arms (1)

Single tooth restorations

EXPERIMENTAL

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.

Device: PrimeTaper EV implant

Interventions

PrimeTaper EV implant DEVICE

Tapered dental implant developed by Dentsply Sirona

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:

• 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

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 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.

Sponsors & Collaborators

• Dentsply Sirona Implants and Consumables: lead

Study Sites (5)

University of Iowa

Iowa City, Iowa, 52242-1010, United States

Location

Catholic University of Leuven

Leuven, B-3000, Belgium

Location

Dental practice Dr Mischa Krebs

Alzey, DE-55232, Germany

Location

Studio Toia

Busto Arsizio, IT-21052, Italy

Location

Dr.F.L.Guljé, De Mondhoek

Apeldoorn, 7315CA, Netherlands

Location

MeSH Terms

Conditions

Jaw, Edentulous, Partially

Condition Hierarchy (Ancestors)

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

Study Officials

• Andy Temmerman, Prof.

  KU Leuven

  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: March 16, 2022
• First Posted: April 7, 2022
• Study Start: May 3, 2022
• Primary Completion: March 12, 2025
• Study Completion (Estimated): May 1, 2029
• Last Updated: August 28, 2025

Record last verified: 2025-08

Locations

IT (1); DE (1); US (1); BE (1); NL (1)