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New study tests whether computer guidance makes dental implants more reliable

NCT ID NCT05264545

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares two ways of placing PrimeTaper dental implants: one using a surgical guide (guided) and one without (non-guided). About 100 adults missing one or more teeth will receive implants and be followed for a year to see how many implants survive and stay stable. The goal is to find out if guided surgery leads to better outcomes for immediate tooth replacement.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PrimeTaper EV dental implant
What this could lead to
If successful, this could show that guided surgery improves implant survival and stability, leading to better outcomes for people needing tooth replacements.
What could go wrong
This is a non-randomized study with only 100 participants, so results may not apply to everyone. The implant is already approved, so this is about refining technique, not a breakthrough.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

100 people

The number who actually took part.

Started

Mar 2022

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

25 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Colorado Gum Care

    Broomfield, Colorado, 80020, United States

  • McClain and Schallhorn Periodontics and Implant Dentistry

    Aurora, Colorado, 80012-3260, United States

  • Metro West Orthodontics & Periodontics

    La Vista, Nebraska, 68128, United States

  • Oral Health Specialists

    Tacoma, Washington, 98405-1462, United States

  • Perio & Implant Associates of Middle TN

    Nashville, Tennessee, 37215, United States

  • Perio Health Professionals

    Houston, Texas, 77063-7229, United States

  • Periodontal Medicine Surgical Specialists, LLC

    Oakbrook Terrace, Illinois, 60181, United States

  • WisNova Institute of Dental Specialists

    Kenosha, Wisconsin, 53144-4292, United States