Non-Guided vs. Guided Surgery to Immediately Loaded PrimeTaper Implants in Partially Edentulous Patients
NCT ID: NCT05264545
Last Updated: 2025-05-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
100 participants
INTERVENTIONAL
2022-03-22
2026-10-31
Brief Summary
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Detailed Description
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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
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Single Arm
There are no arms in the study, it is a non randomized, controlled study
PrimeTaper EV
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.
Interventions
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PrimeTaper EV
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.
Eligibility Criteria
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Inclusion Criteria
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
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.
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.
25 Years
ALL
No
Sponsors
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Dentsply Sirona Implants and Consumables
INDUSTRY
McGuire Institute
INDUSTRY
Responsible Party
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Locations
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McClain and Schallhorn Periodontics and Implant Dentistry
Aurora, Colorado, United States
Colorado Gum Care
Broomfield, Colorado, United States
Periodontal Medicine Surgical Specialists, LLC
Oakbrook Terrace, Illinois, United States
Metro West Orthodontics & Periodontics
La Vista, Nebraska, United States
Perio & Implant Associates of Middle TN
Nashville, Tennessee, United States
Perio Health Professionals
Houston, Texas, United States
Oral Health Specialists
Tacoma, Washington, United States
WisNova Institute of Dental Specialists
Kenosha, Wisconsin, United States
Countries
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References
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Jung RE, Pjetursson BE, Glauser R, Zembic A, Zwahlen M, Lang NP. A systematic review of the 5-year survival and complication rates of implant-supported single crowns. Clin Oral Implants Res. 2008 Feb;19(2):119-30. doi: 10.1111/j.1600-0501.2007.01453.x. Epub 2007 Dec 7.
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.
3. American Dental Association, Patient Smart Dental Implants. Accessed August 15, 2021.
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.
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.
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.
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.
8. ITI.org Consensus Statement, Amsterdam 2018. Implant Placement and Loading Protocols
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.
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.
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.
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.
13. ISO. EN ISO 14155. SS-EN ISO 14155:2011: Swedish Standard Institute; 2011
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.
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.
Other Identifiers
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DS2021-01
Identifier Type: -
Identifier Source: org_study_id
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