Partially Edentulous Maxilla or MandibleNCT05264545

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

A study testing PrimeTaper EV in people with Partially Edentulous Maxilla or Mandible, run by McGuire Institute at 8 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

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

Who is it for?: Ages 25 years and older
Conditions the study is for: Partially Edentulous Maxilla or Mandible
What is being tested?: PrimeTaper EV
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 8 sitesUnited States
Study dates: 22 Mar 2022to Dec 2026
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 25 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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.).

Show all 19Show fewer

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.

Trial locations and contacts

8 sites in 1 country.

City, postcode or hospital

8 sites in 1 country

United States8 sites

McClain and Schallhorn Periodontics and Implant Dentistry
Aurora, Colorado, 80012-3260
Colorado Gum Care
Broomfield, Colorado, 80020
Perio Health Professionals
Houston, Texas, 77063-7229
WisNova Institute of Dental Specialists
Kenosha, Wisconsin, 53144-4292
Metro West Orthodontics & Periodontics
La Vista, Nebraska, 68128
Perio & Implant Associates of Middle TN
Nashville, Tennessee, 37215
Periodontal Medicine Surgical Specialists, LLC
Oakbrook Terrace, Illinois, 60181
Oral Health Specialists
Tacoma, Washington, 98405-1462

Other trials in United States

About this study

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

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

Read the 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

Conditions: Partially Edentulous Maxilla or Mandible
Being tested: PrimeTaper EV

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PrimeTaper EVDevice
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.

Study groups in NCT05264545
Study group	Role	What they receive
Single Arm	Other	There are no arms in the study, it is a non randomized, controlled study Receives: Device: PrimeTaper EV

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 1 year after final restoration

Secondary outcomes (17)

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.
Measured: 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.
Measured: 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)
Measured: 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: 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: 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: 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: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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.
Measured: 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.
Measured: 5 years after final restoration attachment.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

22 Mar 2022Dec 2026

First posted3 Mar 2022
Study start22 Mar 2022
Primary completionAug 2026 (estimated)
Study completionDec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Partially Edentulous Maxilla or MandibleStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Model description: Prospective, multicenter, non-randomized, controlled
Masking: None (open label)
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05264545
Sponsor's protocol ID: DS2021-01
Status last verified: Jun 2026
First submitted: 24 Sep 2021
Last updated: 24 Jun 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 30328194
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.
PubMed 5237684
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.
PubMed 25030551
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.
PubMed 18067597
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.
PubMed 30075090
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.
PubMed 22157097
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.
PubMed 22551385
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.
PubMed 29608793
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.
PubMed 31958166
8. ITI.org Consensus Statement, Amsterdam 2018. Implant Placement and Loading Protocols
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.
PubMed 32400121
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.
PubMed 30328185
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.
PubMed 25951678
13. ISO. EN ISO 14155. SS-EN ISO 14155:2011: Swedish Standard Institute; 2011

Study at a glance

From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Prospective, Multicenter, Non-randomized, Controlled Clinical Study Utilizing Non-Guided vs. Guided Surgery to Immediately Loaded PrimeTaper Implants in Partially Edentulous Patients
ClinicalTrials.gov ID: NCT05264545
Acronym / sponsor ID: DS2021-01
Conditions: Partially Edentulous Maxilla or Mandible
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 100 participants (actual)
Lead sponsor: McGuire InstituteIndustry (pharma, biotech, devices)
Collaborators: Dentsply Sirona Implants and Consumables
Study start: 22 Mar 2022 (actual)
Primary completion: Aug 2026 (estimated)
Study completion: Dec 2026 (estimated)
First posted: 3 Mar 2022 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Prospective, multicenter, non-randomized, controlled

Arm	Type	Receives
Single Arm	Other	Device: PrimeTaper EVThere are no arms in the study, it is a non randomized, controlled study

Who may qualify

Ages: 25 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (19 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
PrimeTaper EVThe 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.	Device	Single Arm

Primary outcome

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
Time frame: 1 year after final restoration
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.

17 secondary outcomes

Implant stability by manual clinical examination
Time frame: throughout study, up to the 5 year follow up
Implant survival rate
Time frame: 2, 3, 4, and 5 years after final restoration attachment
Maintenance of marginal bone levels on patient- and implant level.
Time frame: throughout study up to the 5 year follow up visit
Condition of the peri-implant mucosa (Plaque Index)
Time frame: 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)
Time frame: 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).
Time frame: 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.
Time frame: measured at 12 days, 20 weeks, 1,2,3,4,5 years
Patient Reported Outcomes (PROs)
Time frame: 20 weeks, 6 months, years 1,2,3,4,5
Patient Reported Outcomes (PROs)
Time frame: 20 weeks, 6 months, years 1,2,3,4,5
Patient Reported Outcomes (PROs)
Time frame: 20 weeks, 6 months, years 1,2,3,4,5
Investigator Assessment of the Implant-Prosthetic Complex
Time frame: 20 weeks and 5 years.
Investigator Assessment of the Implant-Prosthetic Complex
Time frame: 20 weeks and 5 years.
Investigator Assessment of the Implant-Prosthetic Complex
Time frame: 20 weeks and 5 years.
Investigator Assessment of the Implant-Prosthetic Complex
Time frame: 20 weeks and 5 years.
Implant success
Time frame: throughout study up to the 5 year follow up visit
Prosthetic survival
Time frame: 5 years after final restoration attachment
Prosthetic success
Time frame: 5 years after final restoration attachment.

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
Background: PubMed 30328194Gallucci 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.
Background: PubMed 5237684Loe 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.
Background: PubMed 25030551Geraets 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.
Results publication: PubMed 18067597Jung 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.
Results publication: PubMed 30075090Elani 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.
Results publication3. American Dental Association, Patient Smart Dental Implants. Accessed August 15, 2021.
Results publication: PubMed 22157097Papaspyridakos 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.
Results publication: PubMed 22551385Kuhl 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.
Results publication: PubMed 29608793Younes 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.
Results publication: PubMed 31958166Varga 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.
Results publication8. ITI.org Consensus Statement, Amsterdam 2018. Implant Placement and Loading Protocols
Results publication: PubMed 32400121Naeini 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.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

8 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing PrimeTaper EV in people with Partially Edentulous Maxilla or Mandible, run by McGuire Institute at 8 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 8 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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 (time frame: 1 year after final restoration). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05264545, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.