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

Primary Purpose

Partially Edentulous Maxilla or Mandible

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PrimeTaper EV
Sponsored by
McGuire Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Partially Edentulous Maxilla or Mandible

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • McClain and Schallhorn Periodontics and Implant DentistryRecruiting
  • Colorado Gum CareRecruiting
  • Misch Implant Dentistry
  • Periodontal Medicine Surgical Specialists, LLCRecruiting
  • Metro West Orthodontics & PeriodonticsRecruiting
  • Perio & Implant Associates of Middle TNRecruiting
  • Perio Health ProfessionalsRecruiting
  • Oral Health SpecialistsRecruiting
  • WisNova Institute of Dental SpecialistsRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Single Arm

Arm Description

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

Outcomes

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
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.

Secondary Outcome Measures

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.
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.
Maintenance of marginal bone levels on patient- and implant level.
Changes (mm) in marginal bone level (MBL)
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.
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.
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.
Condition of the peri-implant mucosa.
Keratinized Tissue Width (KTw) will be measures following implant placement
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
Patient Reported Outcomes (PROs)
subjects will be interviewed to ask about Esthetics using a 0 (completely displeased)-10 (completely pleased) point grading system
Patient Reported Outcomes (PROs)
subjects will be interviewed to ask about Satisfaction using a 0 (completely dissatisfied) -10 (completely satisfied) point grading system
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)
Investigator Assessment of the Implant-Prosthetic Complex
Evaluation of Function a 4 point scale (1=very good, 2= good, 3=acceptable, 4=not acceptable)
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)
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)
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
Prosthetic survival
Proportion of original permanent prosthetic restorations still in place at the 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.

Full Information

First Posted
September 24, 2021
Last Updated
May 25, 2022
Sponsor
McGuire Institute
Collaborators
Dentsply Sirona Implants and Consumables
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1. Study Identification

Unique Protocol Identification Number
NCT05264545
Brief Title
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

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 22, 2022 (Actual)
Primary Completion Date
June 2028 (Anticipated)
Study Completion Date
August 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McGuire Institute
Collaborators
Dentsply Sirona Implants and Consumables

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partially Edentulous Maxilla or Mandible

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective, multicenter, non-randomized, controlled
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Single Arm
Arm Type
Other
Arm Description
There are no arms in the study, it is a non randomized, controlled study
Intervention Type
Device
Intervention Name(s)
PrimeTaper EV
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
1 year after final restoration
Secondary Outcome Measure Information:
Title
Implant stability by manual clinical examination
Description
Mobility (manual stability) will be assessed by a percussion test for resonance indicative of bone to implant contact vertically and laterally.
Time Frame
throughout study, up to the 5 year follow up
Title
Implant survival rate
Description
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.
Time Frame
2, 3, 4, and 5 years after final restoration attachment
Title
Maintenance of marginal bone levels on patient- and implant level.
Description
Changes (mm) in marginal bone level (MBL)
Time Frame
throughout study up to the 5 year follow up visit
Title
Condition of the peri-implant mucosa (Plaque Index)
Description
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.
Time Frame
measured at 12 days (no BOP, PPD), 16 weeks, 20 weeks, 6 months, 1,2,3,4,5 years,
Title
Condition of the peri-implant mucosa (Recession)
Description
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.
Time Frame
measured at 12 days (no BOP, PPD), 16 weeks, 20 weeks, 6 months, 1,2,3,4,5 years,
Title
Condition of the peri-implant mucosa (Suppuration by visual inspection).
Description
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.
Time Frame
measured at 12 days (no BOP, PPD), 16 weeks, 20 weeks, 6 months, 1,2,3,4,5 years,
Title
Condition of the peri-implant mucosa.
Description
Keratinized Tissue Width (KTw) will be measures following implant placement
Time Frame
measured at 12 days, 20 weeks, 1,2,3,4,5 years
Title
Patient Reported Outcomes (PROs)
Description
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
Time Frame
20 weeks, 6 months, years 1,2,3,4,5
Title
Patient Reported Outcomes (PROs)
Description
subjects will be interviewed to ask about Esthetics using a 0 (completely displeased)-10 (completely pleased) point grading system
Time Frame
20 weeks, 6 months, years 1,2,3,4,5
Title
Patient Reported Outcomes (PROs)
Description
subjects will be interviewed to ask about Satisfaction using a 0 (completely dissatisfied) -10 (completely satisfied) point grading system
Time Frame
20 weeks, 6 months, years 1,2,3,4,5
Title
Investigator Assessment of the Implant-Prosthetic Complex
Description
Evaluation of the Esthetic outcome on a 4 point scale (1=very good, 2= good, 3=acceptable, 4=not acceptable)
Time Frame
20 weeks and 5 years.
Title
Investigator Assessment of the Implant-Prosthetic Complex
Description
Evaluation of Function a 4 point scale (1=very good, 2= good, 3=acceptable, 4=not acceptable)
Time Frame
20 weeks and 5 years.
Title
Investigator Assessment of the Implant-Prosthetic Complex
Description
Evaluation of Gingival Health n a 4 point scale (1=very good, 2= good, 3=acceptable, 4=not acceptable)
Time Frame
20 weeks and 5 years.
Title
Investigator Assessment of the Implant-Prosthetic Complex
Description
Evaluation of Bone Level of the permanent prosthetic restoration n a 4 point scale (1=very good, 2= good, 3=acceptable, 4=not acceptable)
Time Frame
20 weeks and 5 years.
Title
Implant success
Description
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
Time Frame
throughout study up to the 5 year follow up visit
Title
Prosthetic survival
Description
Proportion of original permanent prosthetic restorations still in place at the 5 years after final restoration attachment.
Time Frame
5 years after final restoration attachment
Title
Prosthetic success
Description
Analysis of successful permanent prosthetic restorations (implant-prosthetic complex); Number of suprastructure fractures, technical repairs 5 years after final restoration attachment.
Time Frame
5 years after final restoration attachment.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
McClain and Schallhorn Periodontics and Implant Dentistry
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80012-3260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lynn Bellis, RDH
Phone
303-696-7885
Email
rdhlynn@comcast.net
First Name & Middle Initial & Last Name & Degree
Pam McClain, DDS
First Name & Middle Initial & Last Name & Degree
Rachel Schallhorn, DDS
Facility Name
Colorado Gum Care
City
Broomfield
State/Province
Colorado
ZIP/Postal Code
80020
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tyler Borg, DDS
Phone
303-469-6375
Email
tyler.borg@me.com
First Name & Middle Initial & Last Name & Degree
Tyler Borg, DDS
Facility Name
Misch Implant Dentistry
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34237
Country
United States
Individual Site Status
Terminated
Facility Name
Periodontal Medicine Surgical Specialists, LLC
City
Oakbrook Terrace
State/Province
Illinois
ZIP/Postal Code
60181
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
George Mandelaris, DDS
Phone
630-627-3930
Email
gmandelaris@periodontalmedicine.org
First Name & Middle Initial & Last Name & Degree
George Mandelaris, DDS
First Name & Middle Initial & Last Name & Degree
Brad DeGroot, DDS
Facility Name
Metro West Orthodontics & Periodontics
City
La Vista
State/Province
Nebraska
ZIP/Postal Code
68128
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Becki Cole, RDH
Phone
402-614-7022
Email
vp3dimaging@hotmail.com
First Name & Middle Initial & Last Name & Degree
Takanari Miyamoto, DDS
Facility Name
Perio & Implant Associates of Middle TN
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37215
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Meister, DDS
Phone
615-297-8973
Email
drmeister@tnperio.com
First Name & Middle Initial & Last Name & Degree
David Meister, DDS
Facility Name
Perio Health Professionals
City
Houston
State/Province
Texas
ZIP/Postal Code
77063-7229
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Madeline DuPree, RDH
Phone
713-783-5442
Email
madeline@periohealth.com
First Name & Middle Initial & Last Name & Degree
Carol H Waring, RDH
Phone
7137835442
Email
carol@periohealth.com
First Name & Middle Initial & Last Name & Degree
Todd Scheyer, DDS
First Name & Middle Initial & Last Name & Degree
Michael McGuire, DDS
First Name & Middle Initial & Last Name & Degree
Andrew Rossi, DDS
Facility Name
Oral Health Specialists
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405-1462
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kaylan Pierson
Phone
253-752-6622
Email
info@oralhealthspecialists.com
First Name & Middle Initial & Last Name & Degree
Jim Janakievski, DDS
First Name & Middle Initial & Last Name & Degree
Ashley Hoders, DDS
Facility Name
WisNova Institute of Dental Specialists
City
Kenosha
State/Province
Wisconsin
ZIP/Postal Code
53144-4292
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miranda Cebula
Phone
262-654-6770
Email
miranda@wisnova.com
First Name & Middle Initial & Last Name & Degree
Greg Santarelli, DDS
First Name & Middle Initial & Last Name & Degree
Deno Tiboris, DDS

12. IPD Sharing Statement

Plan to Share IPD
No
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30328194
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Non-Guided vs. Guided Surgery to Immediately Loaded PrimeTaper Implants in Partially Edentulous Patients

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