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

NCT05264545 | Active Not Recruiting FDA Device

• 1 other identifier: DS2021-01
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 8

Brief Summary

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

Conditions

Partially Edentulous Maxilla or Mandible

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (17)

• Implant stability by manual clinical examination

  throughout study, up to the 5 year follow up

• Implant survival rate

  2, 3, 4, and 5 years after final restoration attachment

• Maintenance of marginal bone levels on patient- and implant level.

  throughout study up to the 5 year follow up visit

• Condition of the peri-implant mucosa (Plaque Index)

  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)

  measured at 12 days (no BOP, PPD), 16 weeks, 20 weeks, 6 months, 1,2,3,4,5 years,

Study Arms (1)

Single Arm

OTHER

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

Device: PrimeTaper EV

Interventions

PrimeTaper EV DEVICE

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.

Single Arm

Eligibility Criteria

• Age: 25 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• McGuire Institute: lead
• Dentsply Sirona Implants and Consumables: collaborator

Study Sites (8)

McClain and Schallhorn Periodontics and Implant Dentistry

Aurora, Colorado, 80012-3260, United States

Location

Colorado Gum Care

Broomfield, Colorado, 80020, United States

Location

Periodontal Medicine Surgical Specialists, LLC

Oakbrook Terrace, Illinois, 60181, United States

Location

Metro West Orthodontics & Periodontics

La Vista, Nebraska, 68128, United States

Location

Perio & Implant Associates of Middle TN

Nashville, Tennessee, 37215, United States

Location

Perio Health Professionals

Houston, Texas, 77063-7229, United States

Location

Oral Health Specialists

Tacoma, Washington, 98405-1462, United States

Location

WisNova Institute of Dental Specialists

Kenosha, Wisconsin, 53144-4292, United States

Location

Related Publications (15)

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  PMID: 18067597 BACKGROUND

• Elani HW, Starr JR, Da Silva JD, Gallucci GO. Trends in Dental Implant Use in the U.S., 1999-2016, and Projections to 2026. J Dent Res. 2018 Dec;97(13):1424-1430. doi: 10.1177/0022034518792567. Epub 2018 Aug 3.

  PMID: 30075090 BACKGROUND

• 3. American Dental Association, Patient Smart Dental Implants. Accessed August 15, 2021.

  BACKGROUND

• Papaspyridakos P, Chen CJ, Singh M, Weber HP, Gallucci GO. Success criteria in implant dentistry: a systematic review. J Dent Res. 2012 Mar;91(3):242-8. doi: 10.1177/0022034511431252. Epub 2011 Dec 8.

  PMID: 22157097 BACKGROUND

• Kuhl S, Zurcher S, Mahid T, Muller-Gerbl M, Filippi A, Cattin P. Accuracy of full guided vs. half-guided implant surgery. Clin Oral Implants Res. 2013 Jul;24(7):763-9. doi: 10.1111/j.1600-0501.2012.02484.x. Epub 2012 May 3.

  PMID: 22551385 BACKGROUND

• Younes F, Cosyn J, De Bruyckere T, Cleymaet R, Bouckaert E, Eghbali A. A randomized controlled study on the accuracy of free-handed, pilot-drill guided and fully guided implant surgery in partially edentulous patients. J Clin Periodontol. 2018 Jun;45(6):721-732. doi: 10.1111/jcpe.12897. Epub 2018 May 10.

  PMID: 29608793 BACKGROUND

• Varga E Jr, Antal M, Major L, Kiscsatari R, Braunitzer G, Piffko J. Guidance means accuracy: A randomized clinical trial on freehand versus guided dental implantation. Clin Oral Implants Res. 2020 May;31(5):417-430. doi: 10.1111/clr.13578. Epub 2020 Jan 31.

  PMID: 31958166 BACKGROUND

• 8. ITI.org Consensus Statement, Amsterdam 2018. Implant Placement and Loading Protocols

  BACKGROUND

• Gallucci GO, Hamilton A, Zhou W, Buser D, Chen S. Implant placement and loading protocols in partially edentulous patients: A systematic review. Clin Oral Implants Res. 2018 Oct;29 Suppl 16:106-134. doi: 10.1111/clr.13276.

  PMID: 30328194 BACKGROUND

• Naeini EN, Atashkadeh M, De Bruyn H, D'Haese J. Narrative review regarding the applicability, accuracy, and clinical outcome of flapless implant surgery with or without computer guidance. Clin Implant Dent Relat Res. 2020 Aug;22(4):454-467. doi: 10.1111/cid.12901. Epub 2020 May 13.

  PMID: 32400121 BACKGROUND

• Sailer I, Strasding M, Valente NA, Zwahlen M, Liu S, Pjetursson BE. A systematic review of the survival and complication rates of zirconia-ceramic and metal-ceramic multiple-unit fixed dental prostheses. Clin Oral Implants Res. 2018 Oct;29 Suppl 16:184-198. doi: 10.1111/clr.13277.

  PMID: 30328185 BACKGROUND

• General Assembly of the World Medical Association. World Medical Association Declaration of Helsinki: ethical principles for medical research involving human subjects. J Am Coll Dent. 2014 Summer;81(3):14-8.

  PMID: 25951678 BACKGROUND

• 13. ISO. EN ISO 14155. SS-EN ISO 14155:2011: Swedish Standard Institute; 2011

  BACKGROUND

• Loe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. doi: 10.1902/jop.1967.38.6.610. No abstract available.

  PMID: 5237684 BACKGROUND

• Geraets W, Zhang L, Liu Y, Wismeijer D. Annual bone loss and success rates of dental implants based on radiographic measurements. Dentomaxillofac Radiol. 2014;43(7):20140007. doi: 10.1259/dmfr.20140007. Epub 2014 Jul 17.

  PMID: 25030551 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Prospective, multicenter, non-randomized, controlled

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: March 3, 2022
• Study Start: March 22, 2022
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (8)