Guided Surgery for Dental Implants in Partially Edentulous Patients

Not currently recruiting at 7 trial locations

Overseen By Takanari Miyamoto, DDS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: McGuire Institute

Must not be taking: Corticosteroids, IV bisphosphonates

Disqualifiers: Malignancy, Chemotherapy, Diabetes, Smoking, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 6

Duration: 20 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new dental device called PrimeTaper EV for individuals needing one or more teeth replaced with implants and seeking quick restoration. The goal is to evaluate the device's effectiveness for those with a healed area in their mouth or requiring teeth extraction and replacement with implants. Ideal participants have stable teeth or dentures in the opposing jaw and desire immediate loading of the implants. This trial may suit those missing teeth and seeking a fast solution. As an unphased trial, it offers participants the chance to contribute to innovative dental solutions and potentially benefit from a rapid restoration process.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it excludes those using systemic corticosteroids, IV bisphosphonates, or any medication that could affect healing. It's best to discuss your specific medications with the trial team.

What prior data suggests that this dental device is safe for use in guided surgery for dental implants?

Research has shown that the PrimeTaper EV dental implant is generally well-tolerated. The FDA has already approved it for dental use, indicating its safety. Over five years, dentists have provided positive feedback on its ease of placement and the results it delivers. No major reports of serious side effects have emerged, and it has proven effective for those needing tooth replacements. This history supports the safety of the PrimeTaper EV implant for use in humans. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the PrimeTaper EV treatment because it offers a new approach to dental implants for partially edentulous patients. Unlike traditional methods that rely on freehand surgery, PrimeTaper EV uses guided surgery, which provides greater precision and accuracy during the implant placement process. This can potentially lead to better outcomes, such as improved implant stability and reduced recovery time. By enhancing the accuracy of implant positioning, PrimeTaper EV aims to improve patient satisfaction and long-term success rates compared to conventional techniques.

What evidence suggests that the PrimeTaper EV dental implant is effective for dental implants in partially edentulous patients?

Research has shown that the PrimeTaper EV dental implant achieves high success rates and patient satisfaction. One study found it performed well for at least three years. This implant suits individuals needing to replace one or more missing teeth. It allows for immediate restoration, enabling the new tooth to be placed right away. Overall, evidence supports its effectiveness in assisting those with missing teeth. ^{2 3 6 7 8}

Are You a Good Fit for This Trial?

This trial is for adults over 25 needing dental implants where immediate loading is preferred. They must have stable occlusion with dentures, bridges, crowns, or natural teeth and sign a consent form. Excluded are those needing major bone grafts, with uncontrolled oral diseases or systemic conditions affecting healing, heavy smokers, pregnant women, recent chemotherapy or radiation patients in the head/neck area.

Inclusion Criteria

I need a dental bridge for areas where I have missing teeth or teeth that need removal.

Subject has signed and dated the informed consent form prior to any study procedures

My opposing jaw has stable teeth or dental work where I'm getting treatment.

Exclusion Criteria

Subject is not willing to participate in the study or unable to understand the content of the study

I have had chemotherapy within the last 5 years.

Unable or unwilling to return for follow-up visits for a period of 5 years

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive PrimeTaper EV implants using non-guided or guided surgical techniques

20 weeks

Multiple visits for implant placement and initial assessments

Follow-up

Participants are monitored for implant survival, success, and patient-reported outcomes

5 years

Regular follow-up visits at 6 months, 1, 2, 3, 4, and 5 years

What Are the Treatments Tested in This Trial?

Interventions

• PrimeTaper EV

Trial Overview The study tests PrimeTaper EV dental implants in partially toothless patients to see if non-guided surgery versus guided surgery affects the success of immediately loaded implants.

How Is the Trial Designed?

Group I: Single Arm Experimental Treatment 1 Intervention

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

PrimeTaper EV is already approved in United States for the following indications:

Approved in United States as PrimeTaper EV Dental Implant for:

• Single tooth replacement
• Multiple tooth replacement
• Immediate restoration/loading in partially edentulous patients

Who Is Running the Clinical Trial?

McGuire Institute

Lead Sponsor

Trials

7

Recruited

390+

Dentsply Sirona Implants and Consumables

Industry Sponsor

Trials

68

Recruited

4,800+

Simon Campion

Dentsply Sirona Implants and Consumables

Chief Executive Officer since 2022

PhD in Chemistry from Texas A&M University

Dr. Patrizia Cavazzoni

Dentsply Sirona Implants and Consumables

Chief Medical Officer

MD from Harvard Medical School

Dentsply Sirona Implants

Industry Sponsor

Trials

63

Recruited

4,600+

Simon Campion

Dentsply Sirona Implants

Chief Executive Officer since 2022

PhD in Chemistry from Texas A&M University

Dr. David Ferguson

Dentsply Sirona Implants

Chief Medical Officer

MD from Harvard Medical School

Published Research Related to This Trial

A systematic review of clinical data from publications since 1981 identified that the most common complications associated with endosseous root form implants include loosening of overdenture mechanisms (33%) and implant loss in irradiated maxillae (25%).

The study suggests that implant prostheses tend to have a higher incidence of complications compared to other dental restoration methods, although a comprehensive overall complication rate could not be established due to the variability in studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical complications with implants and implant prostheses. Goodacre, CJ., Bernal, G., Rungcharassaeng, K., et al.[2022]

In a study involving 20 partially edentulous patients, guided implant surgery using innovative, tooth-supported templates created with a low-cost 3D printer showed a high success rate, with 24 out of 28 templates providing optimal fit and stability.

The procedure was efficient, averaging 15.7 minutes per template, and resulted in a high implant survival rate after one year, indicating that this method is a promising option for restoring missing teeth in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Full in-Office Guided Surgery with Open Selective Tooth-Supported Templates: A Prospective Clinical Study on 20 Patients. Mangano, FG., Hauschild, U., Admakin, O.[2022]

In a clinical study involving 14 patients and 75 dental implants, both the NobelGuide and SimPlant surgical guide systems demonstrated high accuracy and safety, achieving a cumulative survival rate of 98.7% for the implants over a minimum of 12 months.

While both systems allowed for the successful immediate loading of prefabricated provisional restorations, implants placed using bone-supported guides resulted in increased postoperative swelling and discomfort for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Application and success of two stereolithographic surgical guide systems for implant placement with immediate loading. Abboud, M., Wahl, G., Calvo-Guirado, JL., et al.[2022]

Patients with a history of periodontitis may experience higher rates of implant loss and complications compared to periodontally healthy patients, based on a review of nine studies involving various outcome measures.

The evidence is stronger for implant survival rates rather than overall success, but the studies reviewed had significant methodological issues, including bias and inconsistent definitions, which limit the reliability of these conclusions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of implant outcomes in treated periodontitis subjects. Ong, CT., Ivanovski, S., Needleman, IG., et al.[2022]

Guided implant surgery is becoming increasingly important in implant dentistry, supported by the establishment of the Computer Aided Implantology Academy, which highlights its clinical relevance.

Different navigation systems enhance the planning of surgical and prosthetic reconstructions, allowing for minimally invasive procedures that can deliver fixed restorations immediately, especially crucial in the esthetic zone where precision is essential.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Planning implants in the esthetic zone using a new implant 3D navigation system. Rossi, R., Morales, RS., Frascaria, M., et al.[2021]

Zirconia-based implant crowns demonstrated significantly higher fracture resistance compared to PEEK and chromium-cobalt crowns, with mean resistances of 2,567.05 N versus 2,037.24 N and 2,032.10 N, respectively, based on a study involving 36 implant analogs.

The failure mode was most favorable in chromium-cobalt crowns, where all specimens showed veneer failure without damage to other components, indicating a repairable outcome, while zirconia and PEEK had some instances of less desirable failures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of Fracture Resistance and Failure Mode in Digitally Milled Restorations with Rapid Layering by Indirect Composite Resin: An In Vitro Study. Ghodsi, S., Zeighami, S., Etemad, M.[2021]

The Astra Tech OsseoSpeed EV implant demonstrated minimal bone loss (-0.02 mm) after 16 months, indicating its efficacy in maintaining bone levels post-implantation.

Screw-retained restorations showed significantly better maintenance of mean bone levels compared to cemented restorations, suggesting that the type of restoration may influence implant success.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical Evidence of OsseoSpeed EV Implants: A Retrospective Study and Characterization of the Newly Introduced System. Toia, M., Galli, S., Cecchinato, D., et al.[2019]

The OsseoSpeed EV Implants demonstrated a high overall survival rate of 92.6% over a mean follow-up of 42.1 months, with 78% of implants showing no marginal bone loss at the end of the study.

Factors such as bruxism, history of periodontitis, and the diameter of the implants were identified as significant risk factors affecting implant survival, highlighting the importance of patient-specific considerations in dental implant procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and Radiographic Evaluation of OsseoSpeed EV Implants. Esteve-Pardo, G., Esteve-Colomina, L.[2023]

ConeBeam computed tomography (CBCT) enhances 3D dental diagnosis, allowing for better planning and placement of dental implants, which can reduce treatment time and postoperative complications.

While surgical guides improve the accuracy of implant placement, they may not fully compensate for misfits in certain cases, and dentists need to gain experience to effectively use these guides for successful outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Computer-aided manufacturing technologies for guided implant placement. Neugebauer, J., Stachulla, G., Ritter, L., et al.[2009]

In a study of 20 edentulous subjects with two implants each, the clinical indicators of peri-implant health (like bleeding on probing and pocket depth) did not correlate with histological outcomes, suggesting that clinical assessments may not fully reflect the underlying tissue health.

Both zirconia and titanium abutments resulted in healthy peri-implant mucosa after 3 months, indicating that the choice of abutment material does not significantly impact the histological health of the surrounding soft tissues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The association of clinical and microbiologic parameters with histologic observations in relatively healthy peri-implant conditions- a preliminary short-term in vivo study. van Brakel, R., Meijer, GJ., de Putter, C., et al.[2018]

The Endopore implant system offers a unique truncated-conical design that allows for easier placement, the use of shorter implants, and promotes three-dimensional bone ingrowth, leading to faster healing and greater resistance to torque.

Clinical trials involving general practitioners in Canada and the United States suggest that the Endopore system is predictably and reliably successful for dental implant treatments, making it accessible for general dentists to use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Endopore dental implant system: implant treatment simplified. Fleming, AE.[2013]

Implant-retained overdentures are a successful and cost-effective treatment for patients without teeth, with various attachment systems available, each having its own pros and cons.

The new Locator R-Tx abutment by Zest Anchors offers an innovative option for two-implant-supported overdentures, potentially improving retention and stability for patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fabrication of a Mandibular Implant-Supported Overdenture with a New Attachment System: A Review of Current Attachment Systems. Shah, K., Yilmaz, B., McGlumphy, E.[2017]

In a study of 355 dental implants in 108 patients, the prevalence of peri-implantitis was found to be 21.3% at the patient level and 10.7% at the implant level, indicating a significant concern for patients receiving dental implants.

Risk factors for developing peri-implantitis included a history of recurrent periodontitis, significant medical history, and implants placed in areas that underwent guided bone regeneration, highlighting the need for careful patient assessment before implant therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence and risk indicators of peri-implantitis: a university based cross-sectional study. Tsaousoglou, P., Chatzopoulos, GS., Tsalikis, L., et al.[2023]

In a 20-year study involving 18 patients and 95 implants, both Astra Tech and Brånemark implants showed no implant loss or prosthetic failures, indicating high long-term survival rates for both types.

After two decades, there were no significant differences in marginal bone loss between the two implant groups, suggesting that both implant types maintain bone health effectively over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 20-year split-mouth comparative study of two screw-shaped titanium implant systems. Jacobs, R., Gu, Y., Quirynen, M., et al.[2022]

Using a dual-material implant surgical guide made with a vat-polymerization printer offers significant clinical advantages over traditional implant placement methods, enhancing precision and outcomes.

The guide's design features a soft inner layer for better fit and comfort, potentially reducing the need for clinical adjustments during procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fabricating a dual-material, vat-polymerized, additively manufactured static implant surgical guide: A dental technique. Piedra-Cascón, W., Mostafavi, D., Ruiz-de-Gopegui, J., et al.[2022]

Citations

1. centerwatch.com centerwatch.com/clinical-trials/listings/NCT05264545/non-guided-vs-guided-surgery-to-immediately-loaded-primetaper-implants-in-partially-edentulous-patients

Non-Guided vs. Guided Surgery to Immediately Loaded ... The rationale for this study is to provide scientific data on the clinical performance and patient reported outcomes of the PrimeTaper EV ...

2. clinicaltrial.be clinicaltrial.be/en/details/31909?per_page=100&only_recruiting=0&enrolling_by_invitation=1&active_not_recruiting=1&completed=0&only_eligible=0&only_active=0

Non-Guided vs. Guided Surgery to Immediately Loaded Prime... The rationale for this study is to provide scientific data on the clinical performance and patient reported outcomes of the PrimeTaper EV implant when ...

3. withpower.com withpower.com/trial/phase-jaw-edentulous-3-2022-73ee0

PrimeTaper EV Implant for Missing Teeth Restoration This trial is studying how well the PrimeTaper EV dental implant works for people who need to replace one missing tooth. The implant is placed in the ...

4. dentsplysirona.com dentsplysirona.com/en-us/company/news-and-press-release-detail-page.html/content/dam/master/news/en/business-units/implants/2024/dentsply-sirona-primetaper-ev-implant-achieves-high-success-rate-and-satisfaction-in-first-dental-clinical-registry-at-3-year-mark

Dentsply Sirona PrimeTaper EV Implant Achieves High ... Dentsply Sirona's PrimeTaper EV Implant Achieves High Success Rate and Satisfaction in First Dental Clinical Registry at 3-Year Mark.

5. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf21/K210610.pdf

Dentsply Sirona, Inc. Rebecca Sporer Regulatory Affairs ... The PrimeTaper EV Dental Implants are intended to be used in combination with prosthetic components with the conical EV connection (cover screws, healing ...

6. dentsplysirona.com dentsplysirona.com/services/asset/download?path=/content/dam/master/product-procedure-brand-categories/implant-dentistry/collateral-marketing-product/clinical-and-science-support/document/32672783-usx-poster_ongoing-clinical-research-program-on-prime-taper-ev-implant/IMP-Poster-Ongoing-Clinical-Research-Program-on-Prime-Taper-EV-implant-32672783-USX-2309.pdf

A clinical study to evaluate the PrimeTaper EV Implant in ... The Registry collects data from surveys revealing dentist feedback on the placement of PrimeTaper EV implants, restoration and treatment outcomes after 5-years ...

7. dentsplysirona.com dentsplysirona.com/content/dam/master/product-procedure-brand-categories/implant-dentistry/product-categories/implants/ds-primetaper-implant/documents/IMP-Case-Report-DS-PrimeTaper-partially-edentulous-maxilla.pdf

CASE REPORT DS PrimeTaper™ A 68-year-old female patient, ASA-1 presented partial edentulism of the left canine and the two premolars, was wearing a partial removable denture anchored.

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf22/K220841.pdf

Dentsply Sirona Courtney Clark Senior Director of Regulatory ... The proposed (A) PrimeTaper EV Dental Implant Ø3.0 and proposed (B) DS Implants abutments with EV connection XS are single-use devices and are ...