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

May 14, 2025 updated by: McGuire Institute

Prospective, Multicenter, Non-randomized, Controlled Clinical Study Utilizing Non-Guided vs. Guided Surgery to Immediately Loaded PrimeTaper Implants in Partially Edentulous Patients

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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80012-3260
        • McClain and Schallhorn Periodontics and Implant Dentistry
      • Broomfield, Colorado, United States, 80020
        • Colorado Gum Care
    • Illinois
      • Oakbrook Terrace, Illinois, United States, 60181
        • Periodontal Medicine Surgical Specialists, LLC
    • Nebraska
      • La Vista, Nebraska, United States, 68128
        • Metro West Orthodontics & Periodontics
    • Tennessee
      • Nashville, Tennessee, United States, 37215
        • Perio & Implant Associates of Middle TN
    • Texas
      • Houston, Texas, United States, 77063-7229
        • Perio Health Professionals
    • Washington
      • Tacoma, Washington, United States, 98405-1462
        • Oral Health Specialists
    • Wisconsin
      • Kenosha, Wisconsin, United States, 53144-4292
        • WisNova Institute of Dental Specialists

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Single Arm
There are no arms in the study, it is a non randomized, controlled study
Device: PrimeTaper EV
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Time Frame: 1 year after final restoration
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.
1 year after final restoration

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Implant stability by manual clinical examination
Time Frame: throughout study, up to the 5 year follow up
Mobility (manual stability) will be assessed by a percussion test for resonance indicative of bone to implant contact vertically and laterally.
throughout study, up to the 5 year follow up
Implant survival rate
Time Frame: 2, 3, 4, and 5 years after final restoration attachment
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.
2, 3, 4, and 5 years after final restoration attachment
Maintenance of marginal bone levels on patient- and implant level.
Time Frame: throughout study up to the 5 year follow up visit
Changes (mm) in marginal bone level (MBL)
throughout study up to the 5 year follow up visit
Condition of the peri-implant mucosa (Plaque Index)
Time Frame: measured at 12 days (no BOP, PPD), 16 weeks, 20 weeks, 6 months, 1,2,3,4,5 years,
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.
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)
Time Frame: measured at 12 days (no BOP, PPD), 16 weeks, 20 weeks, 6 months, 1,2,3,4,5 years,
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.
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 (Suppuration by visual inspection).
Time Frame: measured at 12 days (no BOP, PPD), 16 weeks, 20 weeks, 6 months, 1,2,3,4,5 years,
Suppuration presence or absence will be measured following implant placement by using a scoring system of 0-1. 0 being no suppuration and 1 being suppuration is present. It is being identified by visual inspection and palpitation of moderate inflammation.
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.
Time Frame: measured at 12 days, 20 weeks, 1,2,3,4,5 years
Keratinized Tissue Width (KTw) will be measures following implant placement
measured at 12 days, 20 weeks, 1,2,3,4,5 years
Patient Reported Outcomes (PROs)
Time Frame: 20 weeks, 6 months, years 1,2,3,4,5
subjects will be interviewed to ask about Discomfort using a 0 (no discomfort)-10 (as much discomfort as i have ever felt) point grading system
20 weeks, 6 months, years 1,2,3,4,5
Patient Reported Outcomes (PROs)
Time Frame: 20 weeks, 6 months, years 1,2,3,4,5
subjects will be interviewed to ask about Esthetics using a 0 (completely displeased)-10 (completely pleased) point grading system
20 weeks, 6 months, years 1,2,3,4,5
Patient Reported Outcomes (PROs)
Time Frame: 20 weeks, 6 months, years 1,2,3,4,5
subjects will be interviewed to ask about Satisfaction using a 0 (completely dissatisfied) -10 (completely satisfied) point grading system
20 weeks, 6 months, years 1,2,3,4,5
Investigator Assessment of the Implant-Prosthetic Complex
Time Frame: 20 weeks and 5 years.
Evaluation of the Esthetic outcome on a 4 point scale (1=very good, 2= good, 3=acceptable, 4=not acceptable)
20 weeks and 5 years.
Investigator Assessment of the Implant-Prosthetic Complex
Time Frame: 20 weeks and 5 years.
Evaluation of Function a 4 point scale (1=very good, 2= good, 3=acceptable, 4=not acceptable)
20 weeks and 5 years.
Investigator Assessment of the Implant-Prosthetic Complex
Time Frame: 20 weeks and 5 years.
Evaluation of Gingival Health n a 4 point scale (1=very good, 2= good, 3=acceptable, 4=not acceptable)
20 weeks and 5 years.
Investigator Assessment of the Implant-Prosthetic Complex
Time Frame: 20 weeks and 5 years.
Evaluation of Bone Level of the permanent prosthetic restoration n a 4 point scale (1=very good, 2= good, 3=acceptable, 4=not acceptable)
20 weeks and 5 years.
Implant success
Time Frame: throughout study up to the 5 year follow up visit
Proportion of implants with the derived answer 'No' on the occurrence of "pain", "mobility", "≥2 mm radiological bone loss from initial placement", "infection", "radiolucency" and "6" or greater on the Subject Satisfaction PRO Question and "Very good", "good" or "acceptable" on each Investigator Evaluation of Esthetic Outcome, Function, Gingival Health, Bone Level
throughout study up to the 5 year follow up visit
Prosthetic survival
Time Frame: 5 years after final restoration attachment
Proportion of original permanent prosthetic restorations still in place at the 5 years after final restoration attachment.
5 years after final restoration attachment
Prosthetic success
Time Frame: 5 years after final restoration attachment.
Analysis of successful permanent prosthetic restorations (implant-prosthetic complex); Number of suprastructure fractures, technical repairs 5 years after final restoration attachment.
5 years after final restoration attachment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

McGuire Institute

Collaborators

Dentsply Sirona Implants and Consumables

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2022

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

October 1, 2026

Study Registration Dates

First Submitted

September 24, 2021

First Submitted That Met QC Criteria

March 2, 2022

First Posted (Actual)

March 3, 2022

Study Record Updates

Last Update Posted (Actual)

May 18, 2025

Last Update Submitted That Met QC Criteria

May 14, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DS2021-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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