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Implant

Guided Surgery for Dental Implants in Partially Edentulous Patients

N/A

Recruiting

Research Sponsored by McGuire Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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 with preference for immediate restoration/loading

Opposing jaw in the treatment area meets stable occlusal conditions like complete denture, partial removable denture, fixed bridges and/or crowns, or natural dentition

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 20 weeks and 5 years.

Awards & highlights

Study Summary

This trial will test a new dental device that can be used for subjects who need one or multiple tooth replacement with implants.

Who is the study for?

This trial is for adults over 25 needing dental implants where immediate loading is preferred. They must have stable occlusion with dentures, bridges, crowns, or natural teeth and sign a consent form. Excluded are those needing major bone grafts, with uncontrolled oral diseases or systemic conditions affecting healing, heavy smokers, pregnant women, recent chemotherapy or radiation patients in the head/neck area.Check my eligibility

What is being tested?

The study tests PrimeTaper EV dental implants in partially toothless patients to see if non-guided surgery versus guided surgery affects the success of immediately loaded implants.See study design

What are the potential side effects?

Potential side effects may include discomfort at the implant site, swelling, bruising from the procedure itself and possible complications related to improper osseointegration (the joining of the implant with bone).

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I need a dental bridge for areas where I have missing teeth or teeth that need removal.

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My opposing jaw has stable teeth or dental work where I'm getting treatment.

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I am 25 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2, 3, 4, and 5 years after final restoration attachment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2, 3, 4, and 5 years after final restoration attachment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2, 3, 4, and 5 years after final restoration attachment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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

Secondary outcome measures

Condition of the peri-implant mucosa (Plaque Index)

Condition of the peri-implant mucosa (Recession)

Condition of the peri-implant mucosa (Suppuration by visual inspection).

+9 more

Trial Design

1Treatment groups

Experimental Treatment

Group I: Single ArmExperimental Treatment1 Intervention

There are no arms in the study, it is a non randomized, controlled study

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Dentsply Sirona Implants and ConsumablesIndustry Sponsor

65 Previous Clinical Trials

4,650 Total Patients Enrolled

McGuire InstituteLead Sponsor

5 Previous Clinical Trials

218 Total Patients Enrolled

Dentsply Sirona ImplantsIndustry Sponsor

62 Previous Clinical Trials

4,555 Total Patients Enrolled

Media Library

PrimeTaper EV (Implant) Clinical Trial Eligibility Overview. Trial Name: NCT05264545 — N/A

Partially Edentulous Jaw Research Study Groups: Single Arm

Partially Edentulous Jaw Clinical Trial 2023: PrimeTaper EV Highlights & Side Effects. Trial Name: NCT05264545 — N/A

PrimeTaper EV (Implant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05264545 — N/A

Partially Edentulous Jaw Patient Testimony for trial: Trial Name: NCT05264545 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you provide an overview of the Canadian locations where this medical experiment is currently in operation?

"The study is presently recruiting patients from 8 medical centres, situated in Tacoma, Oakbrook Terrace, and La Vista amongst others. To reduce the need to travel far distances, it would be prudent to select the clinic closest your geographic location if you choose to participate."

Answered by AI

Are there any vacancies available in this clinical experiment?

"As reported via clinicaltrials.gov, this research initiative is still actively searching for participants. It was initially posted on March 22nd 2022 and last modified on May 25th of the same year."

Answered by AI

How many members of the public have been recruited to participate in this research?

"Affirmative, the information on clinicaltrials.gov implies that this research is actively seeking out patients. The trial was initially launched on March 22nd 2022 and amended most recently in May 25th 2022. This study requires 100 participants to be enrolled at 8 medical centres."

Answered by AI