Non-Guided vs. Guided Surgery to Immediately Loaded PrimeTaper Implants in Partially Edentulous Patients

N/AActive Not RecruitingNCT05264545

McGuire Institute100 enrolled

Overview

A 510k approved dental device for subjects requiring single or multiple tooth replacement with implants where immediate restoration/loading is preferred.

The rationale for this study is to provide scientific data on the clinical performance and patient reported outcomes of the PrimeTaper EV implant when utilizing non-guided vs guided surgical technique. The PrimeTaper EV implant has the OsseoSpeed surface, which is especially indicated for use in soft bone applications where implants with other surface treatments may be less effective. The main interests of this study are to assess the survival and the success rates of the implants supporting maxillary or mandibular fixed single or 2-fixture restorations after 1, 2, 3, 4 and 5 years in function

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

100

Conditions

Partially Edentulous Maxilla or Mandible

Interventions

PrimeTaper EVDEVICE

The PrimeTaper EV Implant is a screw shaped dental implant with a defined surface achieved through grit blasting, followed by a process involving a treatment in diluted hydrofluoric acid. There is a conical connection between the implants and the abutments for a tight and stable connection.

Eligibility

Sex: ALLMin age: 25 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Subject ≥25 years. 2. Subject has signed and dated the informed consent form prior to any study procedures. 3. History of either a healed edentulous area or single or multiple teeth requiring extraction and in need of a single or fixed bridge prosthetic restoration and where immediate restoration/loading is preferred. 4. Opposing jaw in the treatment area meets any of the following stable occlusal conditions: Complete denture Partial removable denture Fixed bridges and/or crowns Natural dentition Exclusion Criteria: Any of the following is regarded as a criterion for exclusion from the study (all criteria apply at study inclusion, but criteria numbered 1-4 also apply during the entire study period): 1. Unlikely to be able to comply with study procedures, according to the Investigator's judgment. 2. Subject is not willing to participate in the study or not able to understand the content of the study. 3. Involved in the planning and conduct of the study. 4. Unable or unwilling to return for follow-up visits for a period of 5 years. 5. Has an uncontrolled pathological process in the oral cavity (e.g. untreated periodontal disease, uncontrolled caries, severe malocclusion, etc.). 6. Known or suspected current malignancy. 7. History of radiation therapy in the head and neck region. 8. History of chemotherapy within 5 years prior to surgery. 9. Systemic or local disease or condition that could compromise post-operative healing and/or osseointegration (e.g., uncontrolled diabetes mellitus as reported by the subject). 10. Use of systemic corticosteroids, IV bisphosphonates or any other medication that could compromise post-operative healing and/or osseointegration. 11. Current alcohol and/or drug abuse. 12. Smoking more than 10 cigarettes of any type per day. 13. Current need for major bone grafting and/or augmentation in the planned implant area (esthetic augmentation and minor facial grafting are allowed). 14. Known pregnancy, or plans to become pregnant during the study period of 5 years 15. Participation in another clinical study within the previous 6 months that may interfere with the present study. Post-surgical Exclusion criteria 16. Insufficient primary stability, as judged by the investigator, of the implant(s). 17. Severe non-compliance to CIP as judged by the Investigator and/or Dentsply Sirona Implants.

Locations (8)

McClain and Schallhorn Periodontics and Implant Dentistry

Aurora, Colorado, United States

Colorado Gum Care

Broomfield, Colorado, United States

Periodontal Medicine Surgical Specialists, LLC

Oakbrook Terrace, Illinois, United States

Metro West Orthodontics & Periodontics

Outcomes

Primary Outcomes

To evaluate implant survival rate at 1 year after final restoration attachment (screw retained when feasible) with single and multiple (fixed bridges) PrimeTaper EV implant(s) utilizing non-guided versus guided surgery

Number of remaining implants counted clinically and radiographically, i.e. 'Yes' or 'No' for each implant where 'Yes' means that the implant is still remaining and 'No' means that the implant is not remaining.

Time frame: 1 year after final restoration

Secondary Outcomes

Implant stability by manual clinical examination

Mobility (manual stability) will be assessed by a percussion test for resonance indicative of bone to implant contact vertically and laterally.

Time frame: throughout study, up to the 5 year follow up

Implant survival rate

Time frame: 2, 3, 4, and 5 years after final restoration attachment

Maintenance of marginal bone levels on patient- and implant level.

Changes (mm) in marginal bone level (MBL)

Time frame: throughout study up to the 5 year follow up visit

Condition of the peri-implant mucosa (Plaque Index)

Plaque index will be measured following implant placement by visual inspection using a scoring system of 0-1, 0 being no plaque is present and 1 being plaque is present.

Time frame: measured at 12 days (no BOP, PPD), 16 weeks, 20 weeks, 6 months, 1,2,3,4,5 years,

Condition of the peri-implant mucosa (Recession)

Recession will be measured following implant placement by placing a probe between the tooth and gum to record depth of recession in millimeters from the crown margin to the gingival margin rounded to the nearest 0.5 mm.

Data from ClinicalTrials.gov

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