New study tests whether computer guidance makes dental implants more reliable
NCT ID NCT05264545
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 Hide 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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Partially edentulous maxilla or mandible are added.
Genom att skicka in godkänner du våra Användarvillkor
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