Edentulous JawKashmirNCT05062863
An Observational Clinical Study of the T3 Dental Implant System
An observational study of Edentulous Jaw, run by ZimVie at 4 sites in 2 countries.
Trial summary
This will be a prospective, observational study where all implants will be placed in either the maxilla or mandible and loaded immediately (within 48 hours), early (within 6-8 weeks) or delayed (> 8 weeks) with a provisional or definitive prosthesis. The implants will be evaluated yearly for 2 years. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Edentulous Jaw
- What is being tested?
- T3 dental implant system
- Type of treatment
- Medical device
- How many people
- 139 participants
- Where
- 4 sitesin 2 countries
- Study dates
- 20 Oct 2021to 1 Jul 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Qualified patient will be those patients who have been newly diagnosed with needing a dental implant (or more than one) in one or more edentulous areas in the maxilla and/or mandible. Patients who have had prior implants in the treatment site that have failed (in need of revision) are not eligible for inclusion.
Who may be able to join
- Patients of either sex and at least 18 years of age.
- Patients for whom a decision has already been made to use a dental implant for the restoration of existing edentulism in the mandible and/or maxilla.
- Prior extracted sites or simultaneous extraction/implant placement.
- Patients must be physically able to tolerate conventional surgical and restorative procedures.
- Patients who provide a signed informed consent.
- Patients who agree to be evaluated for each study visit.
Who cannot join
- Patients who are known to be pregnant at the screening visit or planning to become pregnant within 6 months of study enrollment.
- Patients who have previously failed dental implants at the site intended for study implant placement.
- Patients with active HIV or Hepatitis infection.
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
United States3 sites
University of Florida
Gainesville, Florida, 32610
Jersey Shore University Medical Center
Neptune City, New Jersey, 07753
Virginia Commonwealth University
Richmond, Virginia, 23298
About this study
Official title: A Prospective, Observational Clinical Study of the Safety, Effectiveness and Clinical Benefits of the T3 Dental Implant System
This will be a prospective, observational study where all implants will be placed in either the maxilla or mandible and loaded immediately (within 48 hours), early (within 6-8 weeks) or delayed (> 8 weeks) with a provisional or definitive prosthesis. The implants will be evaluated yearly for 2 years.
Read the detailed description
This study aims to enroll a total of 140 patients (140 implants) who are in need of treatment with dental implants in one or more edentulous areas of the maxilla and/or mandible. Approximately 4 sites will be participating, each one contributing 35 patients to the study dataset.
The main objectives of this study will be:
- The integration success of the dental implant (as measured by mobility)
- The measured changes in peri-implant crestal bone levels for each implant
- Confirmation of clinical benefits
- Conditions
- Edentulous Jaw
- Being tested
- T3 dental implant system
- Medical subject headings
- Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T3 dental implant systemDevice
Also called T3 platform switched certain parallel walled (BOPS), T3 non-platform switched certain parallel walled (BOSS), T3 with DCD platform switched certain parallel walled (BNPS), T3 with DCD non-platform switched certain parallel walled (BNSS)
This clinical study will evaluate patients being treated with the T3 dental implant to confirm its safety and performance (effect of treatment of edentulism). The patients treated will experience a benefit from treatment of edentulism with the T3 dental implant system. The patients will be followed prospectively from the time of exposure (dental implant placement surgery) to outcome (implant survival at 2 years).
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental implant integration
The integration success measured by lack of mobility
Measured: 2 years
Secondary outcomes (1)
Crestal Bone Loss
The measured changes in peri-implant crestal bone levels
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2021
- Study start20 Oct 2021
- Primary completion3 Mar 2026
- Study completion1 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous JawStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 139 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZimVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Hai Bo Wen, PhD, Study director, ZimVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05062863
- Sponsor's protocol ID
- 1804
- Acronym
- Kashmir
- Status last verified
- Jul 2026
- First submitted
- 21 Sep 2021
- Last updated
- 28 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Observational Clinical Study of the Safety, Effectiveness and Clinical Benefits of the T3 Dental Implant System
- ClinicalTrials.gov ID
- NCT05062863
- Acronym / sponsor ID
- Kashmir / 1804
- Conditions
- Edentulous Jaw
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- ZimVieIndustry (pharma, biotech, devices)
- Study start
- 20 Oct 2021 (actual)
- Primary completion
- 3 Mar 2026 (actual)
- Study completion
- 1 Jul 2026 (actual)
- First posted
- 30 Sep 2021 (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.
This will be a prospective, observational study where all implants will be placed in either the maxilla or mandible and loaded immediately (within 48 hours), early (within 6-8 weeks) or delayed (> 8 weeks) with a provisional or definitive prosthesis. The implants will be evaluated yearly for 2 years.
Detailed description
This study aims to enroll a total of 140 patients (140 implants) who are in need of treatment with dental implants in one or more edentulous areas of the maxilla and/or mandible. Approximately 4 sites will be participating, each one contributing 35 patients to the study dataset.
The main objectives of this study will be:
- The integration success of the dental implant (as measured by mobility)
- The measured changes in peri-implant crestal bone levels for each implant
- Confirmation of clinical benefits
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Qualified patient will be those patients who have been newly diagnosed with needing a dental implant (or more than one) in one or more edentulous areas in the maxilla and/or mandible. Patients who have had prior implants in the treatment site that have failed (in need of revision) are not eligible for inclusion.
Key inclusion criteria (6 listed)
- Patients of either sex and at least 18 years of age.
- Patients for whom a decision has already been made to use a dental implant for the restoration of existing edentulism in the mandible and/or maxilla.
- Prior extracted sites or simultaneous extraction/implant placement.
- Patients must be physically able to tolerate conventional surgical and restorative procedures.
- Patients who provide a signed informed consent.
Key exclusion criteria (3 listed)
- Patients who are known to be pregnant at the screening visit or planning to become pregnant within 6 months of study enrollment.
- Patients who have previously failed dental implants at the site intended for study implant placement.
- Patients with active HIV or Hepatitis infection.
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 |
|---|---|---|
| T3 dental implant systemAlso: T3 platform switched certain parallel walled (BOPS), T3 non-platform switched certain parallel walled (BOSS), T3 with DCD platform switched certain parallel walled (BNPS), T3 with DCD non-platform switched certain parallel walled (BNSS)This clinical study will evaluate patients being treated with the T3 dental implant to confirm its safety and performance (effect of treatment of edentulism). The patients treated will experience a benefit from treatment of edentulism with the T3 dental implant system. The patients will be followed prospectively from the time of exposure (dental implant placement surgery) to outcome (implant survival at 2 years). | Device | – |
Primary outcome
Dental implant integration
Time frame: 2 years
The integration success measured by lack of mobility
1 secondary outcome
Crestal Bone Loss
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2026.
- Individual participant dataSharing planned: No
Related trials for Edentulous Jaw
Active, not recruiting
L-PRF Block vs Composite Graft for Horizontal Ridge Augmentation
Alveolar Ridge Resorption After Extraction, Alveolar Bone Loss
Not yet recruitingObservational study
Digital and Conventional Clasp-retained Partial Dentures (DIGICLASP)
Partial Edentulism
Recruiting
Dynamic vs. Static Jaw Relations in Implant-Supported Prostheses: Chewing Efficiency
Chewing Efficiency in Completely Edentulous Patients Rehabilitated With Implant-Supported Full-Arch Prostheses
Active, not recruiting
Multicenter Study to Evaluate the Clinical Outcome of PrimeTaper EV Implant in Single Tooth Restorations
Jaw, Edentulous, Partially
Recruiting
Clinical and Radiographic Evaluation of UV-Treated Dental Implants With or Without Melatonin in the Upper Posterior Jaw
Jaw, Edentulous, Partially, Bone Resorption
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.
Hai Bo Wen, PhD study director
ZimVie
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Edentulous Jaw, run by ZimVie at 4 sites in 2 countries.
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 6 inclusion and 3 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: finished, as of the sponsor's last update on 28 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States, Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Dental implant integration (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Jul 2026.