Clinical trial NCT05264545: Non-Guided vs. Guided Surgery to Immediately Loaded PrimeTaper Implants in Partially Edentulous Patients
Official title: Prospective, Multicenter, Non-randomized, Controlled Clinical Study Utilizing Non-Guided vs. Guided Surgery to Immediately Loaded PrimeTaper Implants in Partially Edentulous Patients
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Partially Edentulous Maxilla or Mandible
Lead sponsor: McGuire Institute
Sponsor class: INDUSTRY
Collaborators: name: Dentsply Sirona Implants and Consumables
First posted: 2022-03-03
Enrollment: 100
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Prospective, multicenter, non-randomized, controlled
Primary purpose: TREATMENT

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

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

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 1 year after final restoration
Secondary outcomes:
measure: Implant stability by manual clinical examination
timeFrame: throughout study, up to the 5 year follow up
measure: Implant survival rate
timeFrame: 2, 3, 4, and 5 years after final restoration attachment
measure: Maintenance of marginal bone levels on patient- and implant level.
timeFrame: throughout study up to the 5 year follow up visit
measure: Condition of the peri-implant mucosa (Plaque Index)
timeFrame: measured at 12 days (no BOP, PPD), 16 weeks, 20 weeks, 6 months, 1,2,3,4,5 years,
measure: Condition of the peri-implant mucosa (Recession)
timeFrame: measured at 12 days (no BOP, PPD), 16 weeks, 20 weeks, 6 months, 1,2,3,4,5 years,
measure: Condition of the peri-implant mucosa (Suppuration by visual inspection).
timeFrame: measured at 12 days (no BOP, PPD), 16 weeks, 20 weeks, 6 months, 1,2,3,4,5 years,
measure: Condition of the peri-implant mucosa.
timeFrame: measured at 12 days, 20 weeks, 1,2,3,4,5 years
measure: Patient Reported Outcomes (PROs)
timeFrame: 20 weeks, 6 months, years 1,2,3,4,5
measure: Patient Reported Outcomes (PROs)
timeFrame: 20 weeks, 6 months, years 1,2,3,4,5
measure: Patient Reported Outcomes (PROs)
timeFrame: 20 weeks, 6 months, years 1,2,3,4,5
measure: Investigator Assessment of the Implant-Prosthetic Complex
timeFrame: 20 weeks and 5 years.
measure: Investigator Assessment of the Implant-Prosthetic Complex
timeFrame: 20 weeks and 5 years.
measure: Investigator Assessment of the Implant-Prosthetic Complex
timeFrame: 20 weeks and 5 years.
measure: Investigator Assessment of the Implant-Prosthetic Complex
timeFrame: 20 weeks and 5 years.
measure: Implant success
timeFrame: throughout study up to the 5 year follow up visit
measure: Prosthetic survival
timeFrame: 5 years after final restoration attachment
measure: Prosthetic success
timeFrame: 5 years after final restoration attachment.
Other outcomes:
Locations:
city: Aurora
country: United States
facility: McClain and Schallhorn Periodontics and Implant Dentistry
state: Colorado
city: Broomfield
country: United States
facility: Colorado Gum Care
state: Colorado
city: Oakbrook Terrace
country: United States
facility: Periodontal Medicine Surgical Specialists, LLC
state: Illinois
city: La Vista
country: United States
facility: Metro West Orthodontics & Periodontics
state: Nebraska
city: Nashville
country: United States
facility: Perio & Implant Associates of Middle TN
state: Tennessee
city: Houston
country: United States
facility: Perio Health Professionals
state: Texas
city: Tacoma
country: United States
facility: Oral Health Specialists
state: Washington
city: Kenosha
country: United States
facility: WisNova Institute of Dental Specialists
state: Wisconsin
Study officials:
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