Edentulous JawAppleNCT04354688
T3 Certain Tapered With DCD vs T3 Certain Tapered Non-DCD
A study testing T3 Certain Tapered Implant in people with Edentulous Jaw, run by ZimVie at 2 sites in 2 countries.
Trial summary
This will be a prospective, randomized multicenter study to determine the safety and efficacy of the T3 Certain Tapered with DCD as compared to T3 Certain Tapered without DCD. All implants will be placed in the maxilla or mandible in a single stage manner and loaded with prosthesis after 6 weeks of healing. 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 Certain Tapered Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 19 Oct 2019to 30 Jun 2024
- Phase
- Interventional
- 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
Who may be able to join
- Patients of either sex and greater than 18 years of age
- Patients for whom a decision has already been made to use a dental implant in the mandible or maxilla.
- Immediate extraction or a prior extracted site
- Patients must be physically able to tolerate conventional surgical and restorative procedures.
- Presence of opposing dentition
- Patients who provide a signed informed consent.
- Patients who agree to be evaluated for each study visit.
- Minimum primary stability, insertion torque > 35Ncm
Who cannot join
- Patients with known systemic diseases such as uncontrolled diabetes, endocrine disease, heart disease, immuno-compromised, or mental disorders.
- Patients with current use of non-steroidal anti-inflammatory drugs, bisphosphonates or corticosteroid treatments.
- Patients with active infection or severe inflammation in the areas intended for implant placement.
- Patients with a > 10 cigarette per day smoking habit.
- Patients with a history of therapeutic radiation to the head or jaw.
- Patients who are known to be pregnant at the screening visit or planning to become pregnant within 6 months of study enrollment.
- Patients with evidence of severe parafunctional habits such as bruxing or clenching.
- Patients with HIV or Hepatitis infection
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Prospective, Randomized, Comparative Clinical Study of the Safety, Efficacy and Clinical Benefits of the T3 Certain Tapered With DCD Implant System
This will be a prospective, randomized multicenter study to determine the safety and efficacy of the T3 Certain Tapered with DCD as compared to T3 Certain Tapered without DCD. All implants will be placed in the maxilla or mandible in a single stage manner and loaded with prosthesis after 6 weeks of healing. Final restorations will take place no later than 4 months following implant placement surgery. The implants will be evaluated yearly for 2 years.
Read the detailed description
This is a multicenter, prospective, randomized study that will assess the the safety and efficacy of the implant systems with:
- Resistance to countertorque testing (mobility)
- Implant Stability Quotient (ISQ)
- Changes in peri-implant crestal bone levels
- Confirmation of clinical benefits
A total of 60 implants, 30 per treatment group will be placed across all participating sites. One patient may contribute more than 1 implant. All implants/ patients will be followed for up to 2 years.
- Conditions
- Edentulous Jaw
- Being tested
- T3 Certain Tapered Implant
- 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 Certain Tapered ImplantDevice
Patients will be randomized to receive either the T3 Certain Tapered with DCD (Test) or the T3 Certain Tapered without DCD (control/active comparator). Both types of implants will be rehabilitated in the same manner (early loading)
| Study group | Role | What they receive |
|---|---|---|
| T3 Certain Tapered implant with DCD | Experimental | Implant will be placed in the maxilla or mandible in a single stage manner and loaded with prosthesis after 6 weeks of healing. Final restorations will take place no later than 4 months following implant placement surgery. The implants will be evaluated yearly for 2 years. Receives: Device: T3 Certain Tapered Implant |
| T3 Certain Tapered implant without DCD | Active comparator | Implant will be placed in the maxilla or mandible in a single stage manner and loaded with prosthesis after 6 weeks of healing. Final restorations will take place no later than 4 months following implant placement surgery. The implants will be evaluated yearly for 2 years. Receives: Device: T3 Certain Tapered Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant survival
Assessed by lack of mobility, resistance to countertorque testing, implant stability measurement
Measured: 2 years
Secondary outcomes (1)
Peri-implant crestal bone levels
Assessed by radiographic measurements of serial 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 posted21 Apr 2020
- Study start19 Oct 2019
- Primary completion1 Feb 2024
- Study completion30 Jun 2024
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Test implant- T3 Certain Tapered implant with DCD Active Comparator- T3 Certain Tapered implant without DCD
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- ZimVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04354688
- Sponsor's protocol ID
- 1802
- Acronym
- Apple
- Status last verified
- Jul 2024
- First submitted
- 16 Apr 2020
- Last updated
- 23 Jul 2024
- 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 23 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Comparative Clinical Study of the Safety, Efficacy and Clinical Benefits of the T3 Certain Tapered With DCD Implant System
- ClinicalTrials.gov ID
- NCT04354688
- Acronym / sponsor ID
- Apple / 1802
- Conditions
- Edentulous Jaw
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- ZimVieIndustry (pharma, biotech, devices)
- Study start
- 19 Oct 2019 (actual)
- Primary completion
- 1 Feb 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 21 Apr 2020 (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, randomized multicenter study to determine the safety and efficacy of the T3 Certain Tapered with DCD as compared to T3 Certain Tapered without DCD. All implants will be placed in the maxilla or mandible in a single stage manner and loaded with prosthesis after 6 weeks of healing. Final restorations will take place no later than 4 months following implant placement surgery. The implants will be evaluated yearly for 2 years.
Detailed description
This is a multicenter, prospective, randomized study that will assess the the safety and efficacy of the implant systems with:
- Resistance to countertorque testing (mobility)
- Implant Stability Quotient (ISQ)
- Changes in peri-implant crestal bone levels
- Confirmation of clinical benefits
A total of 60 implants, 30 per treatment group will be placed across all participating sites. One patient may contribute more than 1 implant. All implants/ patients will be followed for up to 2 years.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Test implant- T3 Certain Tapered implant with DCD Active Comparator- T3 Certain Tapered implant without DCD
| Arm | Type | Receives |
|---|---|---|
| T3 Certain Tapered implant with DCD | Experimental | Device: T3 Certain Tapered ImplantImplant will be placed in the maxilla or mandible in a single stage manner and loaded with prosthesis after 6 weeks of healing. Final restorations will take place no later than 4 months following implant placement surgery. The implants will be evaluated yearly for 2 years. |
| T3 Certain Tapered implant without DCD | Active comparator | Device: T3 Certain Tapered ImplantImplant will be placed in the maxilla or mandible in a single stage manner and loaded with prosthesis after 6 weeks of healing. Final restorations will take place no later than 4 months following implant placement surgery. The implants will be evaluated yearly for 2 years. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Patients of either sex and greater than 18 years of age
- Patients for whom a decision has already been made to use a dental implant in the mandible or maxilla.
- Immediate extraction or a prior extracted site
- Patients must be physically able to tolerate conventional surgical and restorative procedures.
- Presence of opposing dentition
Key exclusion criteria (8 listed)
- Patients with known systemic diseases such as uncontrolled diabetes, endocrine disease, heart disease, immuno-compromised, or mental disorders.
- Patients with current use of non-steroidal anti-inflammatory drugs, bisphosphonates or corticosteroid treatments.
- Patients with active infection or severe inflammation in the areas intended for implant placement.
- Patients with a > 10 cigarette per day smoking habit.
- Patients with a history of therapeutic radiation to the head or jaw.
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 Certain Tapered ImplantPatients will be randomized to receive either the T3 Certain Tapered with DCD (Test) or the T3 Certain Tapered without DCD (control/active comparator). Both types of implants will be rehabilitated in the same manner (early loading) | Device | T3 Certain Tapered implant with DCD, T3 Certain Tapered implant without DCD |
Primary outcome
Implant survival
Time frame: 2 years
Assessed by lack of mobility, resistance to countertorque testing, implant stability measurement
1 secondary outcome
Peri-implant crestal bone levels
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 23 Jul 2024.
- Individual participant dataSharing planned: No
Related trials for Edentulous Jaw
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
Active, not recruiting
A Clinical Study on Acuris™ - Conometric Concept for Single Tooth Restoration
Jaw, Edentulous, Partially
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.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T3 Certain Tapered Implant in people with Edentulous Jaw, run by ZimVie at 2 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 8 inclusion and 8 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 23 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Chile, Greece. 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?
Implant survival (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 23 Jul 2024.