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

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

Detailed Description
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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

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

Conditions
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Partially Edentulous Maxilla or Mandible

Intervention / Treatment
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* Device: PrimeTaper EV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject ≥25 years. Subject has signed and dated the informed consent form prior to any study procedures. 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. 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): Unlikely to be able to comply with study procedures, according to the Investigator's judgment. Subject is not willing to participate in the study or not able to understand the content of the study. Involved in the planning and conduct of the study. Unable or unwilling to return for follow-up visits for a period of 5 years. Has an uncontrolled pathological process in the oral cavity (e.g. untreated periodontal disease, uncontrolled caries, severe malocclusion, etc.). Known or suspected current malignancy. History of radiation therapy in the head and neck region. History of chemotherapy within 5 years prior to surgery. 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). Use of systemic corticosteroids, IV bisphosphonates or any other medication that could compromise post-operative healing and/or osseointegration. Current alcohol and/or drug abuse. Smoking more than 10 cigarettes of any type per day. Current need for major bone grafting and/or augmentation in the planned implant area (esthetic augmentation and minor facial grafting are allowed). Known pregnancy, or plans to become pregnant during the study period of 5 years Participation in another clinical study within the previous 6 months that may interfere with the present study. Post-surgical Exclusion criteria Insufficient primary stability, as judged by the investigator, of the implant(s). Severe non-compliance to CIP as judged by the Investigator and/or Dentsply Sirona Implants.

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Prospective, multicenter, non-randomized, controlled
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 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 | 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 | 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. | 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) | 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) | 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). | 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. | 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) | 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) | 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) | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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. |