Atrophy of Edentulous Alveolar RidgeNCT02404649
Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants After Sinus Floor Elevation
A study testing Two implant designs in a Sinus Bone Augmentation Procedure and Two implant designs in a Sinus Floor Elevation Procedure in people with Atrophy of Edentulous Alveolar Ridge and Partial Edentulism, run by Harvard Medical School (HMS and HSDM) at 1 site in United States.
Trial summary
This is a research study to test the clinical outcome of Trabecular Metal™ Dental Implants (TMDI) (Zimmer Dental Inc Carlsbad, CA, US) in the Maxillary Sinus region. This project will enroll 30 active subjects who will receive two dental implants in the edentulous maxillary molar region. Read more about this study
- Who is it for?
- Ages 21 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Atrophy of Edentulous Alveolar Ridge, Partial Edentulism
- What is being tested?
- Two implant designs in a Sinus Bone Augmentation Procedure and Two implant designs in a Sinus Floor Elevation Procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2012to Dec 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- • The subject male or female between 21-75 years of age and has:
- The ability to understand and sign the informed consent prior to starting the study
- The ability and willingness to comply with all study requirements
- Adequate oral hygiene
- The presence of a atrophic, pneumatized, partially edentulous maxilla requiring a lateral approach technique
- Adequate bone volume to accommodate the planned endosseous dental implant (e.g. sufficient height of bone (5 mm or greater) such that the implant would achieve primary stability, and sufficient width that the implant could be placed within the confines of the existing bone without dehiscence or fenestration. The only implant length utilized in this protocol will be a 10 mm long TMDI (Zimmer)
- Existing teeth that are healthy and adequately restored, and desired a fixed restoration on implants
- had a negative pregnancy test within one week prior to surgery, if of childbearing potential.
Who cannot join
- Subjects who have smoked cigarettes or chewed tobacco within the past year
- History of alcoholism or drug abuse within the past 5 years
- Subjects with Severe bruxing or clenching habits
- Untreated periodontitis
- Subjects at undue risk for an outpatient surgical procedure
- Subjects with the presence of residual roots at the implant site
Show all 24Show fewer
- Subjects with history of site development (extensive bone augmentation) at the implant site in the past 4 months
- Placement of implant in an extraction site that had been healing for less than 2 month
- Presence of local inflammation or mucosal diseases such as lichen planus
- Subjects with uncontrolled diabetes (defined as HA1c > 7.0 percent)
- Subjects with current hematologic disorder or chronic use of Coumadin (or similar) anti-coagulant therapies
- Subjects with history of leukocyte dysfunction and deficiencies
- Subjects with Metabolic bone disorders
- Subjects with history of renal failure
- Subjects with history of liver disease
- Immunocompromised Subjects having HIV, RA, SLE or other collagen vascular disorders
- Subjects with chronic corticosteroid use
- Subjects undergoing chemotherapy
- Subjects with a history of use of IV-based bisphosphonates
- Subjects with history of radiation treatment to the head or neck
- Subjects requiring grafting of bone or mucosal tissue at the time of implant placement, which would require submersion of the implant during the healing period
- Subjects using of any investigational drug or device within the 30 day period immediately prior to implant surgery
- Pregnant women or women intending to become pregnant during this study period.
- Subjects requiring submersion of implants for esthetic reasons
Trial locations and contacts
1 site in 1 country.
United States1 site
Harvard School of Dental Medicine
Boston, Massachusetts, 02115
About this study
Official title: A Prospective Clinical Trial Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants After Staged Sinus Floor Elevation Procedures
This is a research study to test the clinical outcome of Trabecular Metal™ Dental Implants (TMDI) (Zimmer Dental Inc Carlsbad, CA, US) in the Maxillary Sinus region. This project will enroll 30 active subjects who will receive two dental implants in the edentulous maxillary molar region. This 24-month research study will examine the clinical stability of TMDI in both sinus elevation and sinus augmentation environments. The proposed research lays the foundation for improved health care by providing surgeons and restorative dentists with data for determining the effects TMDI have on clinical success in less than optimal osseous environments. The rationale that underlies the investigation is that identification of the influences of trabecular surface design on implant stability in varying bone types will allow routine, predictable use of early loading, which, in turn, will translate into more rapid, economical health care, and improved psychosocial well-being of the patient. If these hypotheses are correct, the results are expected to provide evidence based research data to support early loading and immediate loading of single implants in sites of adequate bone volume, and density with or without the use of graft materials in sinus lift procedures. In addition, it is expected that these results will fundamentally advance the field of implant dentistry and bioengineering by providing information on the principles of the bone density-mechanical environment-implant stability interaction.
Read the detailed description
Specific Aims
Primary Outcome Measures:
- The objective of this study is to allow a preliminary analysis of the resonance frequency values over the 12 month period, which will be the primary outcome
Secondary Outcome Measures:
- To assess Crestal bone level maintenance
Study Arms Bone Augmentation: Placement of two dental implants in Sinus augmented with Puros Cortico-Cancellous Particulate Allograft (70% Cortico and 30% Cancelleous) (Zimmer Dental- Carlsbad, CA, USA)- one implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the initial insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement.
Sinus Elevation only: Placement of two dental implants as mentioned above in sinus augmented by sinus elevation procedure, blood clot and CopiOs Pericardium Membrane (Zimmer Dental- Carlsbad, CA, USA) only. One implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement.
- Being tested
- Two implant designs in a Sinus Bone Augmentation Procedure, Two implant designs in a Sinus Floor Elevation Procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Two implant designs in a Sinus Bone Augmentation ProcedureDevice
Comparing TMDI (Zimmer Dental- Carlsbad, CA, USA) and Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA) biological behavior after a sinus bone augmentation procedure.
Two implant designs in a Sinus Floor Elevation ProcedureDevice
Comparing TMDI (Zimmer Dental- Carlsbad, CA, USA) and Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA) biological behavior after a sinus elevation only procedure.
| Study group | Role | What they receive |
|---|---|---|
| Bone Augmention | Active comparator | Two implant designs in a Sinus Bone Augmentation Procedure. Sinus bone augmentation with Puros Cortico-Cancellous Particulate Allograft (70% Cortico and 30% Cancelleous) (Zimmer Dental- Carlsbad, CA, USA)- one implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the initial insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Receives: Device: Two implant designs in a Sinus Bone Augmentation Procedure |
| Sinus elevation only | Active comparator | Two implant designs in a Sinus Floor Elevation Procedure. Placement of two dental implants as mentioned above in sinus bone augmentation by sinus elevation procedure, blood clot and CopiOs Pericardium Membrane (Zimmer Dental- Carlsbad, CA, USA) only. One implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. Receives: Device: Two implant designs in a Sinus Floor Elevation Procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resonance Frequency Values of Dental Implants
Implant stability quotient (ISQ) is the value on a scale that indicates the level of stability and osseointegration in dental implants. The scale ranges from 1 to 100 and is measured by implant stability meters instruments using resonance frequency analysis (RFA) technique. The acceptable stability range lies between 55-85 ISQ. Lower initial stability will normally increase with time due to the lower mechanical stability being enforced by the bone remodeling process (osseointegration). The overall average ISQ value of all implants over time is approximately 70. A significant decrease in ISQ indicates a potential problem and should be considered an early warning. For each time period three measurements were taken from three different positions on the dental implant and the measurements were averaged for each time period.
Measured: 8 months
Secondary outcomes (1)
Crestal Bone Levels
Evaluating crestal bone levels were performed by measuring (millimeters) vertical bone height gain in the maxillary 2 years postoperatively from CBCT images between control and test group.
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 posted31 Mar 2015 (estimated)
- Study startJul 2012
- Primary completionOct 2014
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Atrophy of Edentulous Alveolar RidgeStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard Medical School (HMS and HSDM)
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kevin Guze, Harvard Medical School (HMS and HSDM)
- Investigators
- Kevin Guze, DMD DMSc MSc, Principal investigator, Harvard School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02404649
- Sponsor's protocol ID
- HarvardMS
- Status last verified
- Jul 2020
- First submitted
- 17 Mar 2015
- Last updated
- 22 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Clinical Trial Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants After Staged Sinus Floor Elevation Procedures
- ClinicalTrials.gov ID
- NCT02404649
- Acronym / sponsor ID
- HarvardMS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Harvard Medical School (HMS and HSDM)University, hospital or other
- Study start
- Jul 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 31 Mar 2015 (estimated)
- Results
- Posted 6 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a research study to test the clinical outcome of Trabecular Metal™ Dental Implants (TMDI) (Zimmer Dental Inc Carlsbad, CA, US) in the Maxillary Sinus region. This project will enroll 30 active subjects who will receive two dental implants in the edentulous maxillary molar region. This 24-month research study will examine the clinical stability of TMDI in both sinus elevation and sinus augmentation environments. The proposed research lays the foundation for improved health care by providing surgeons and restorative dentists with data for determining the effects TMDI have on clinical success in less than optimal osseous environments. The rationale that underlies the investigation is that identification of the influences of trabecular surface design on implant stability in varying bone types will allow routine, predictable use of early loading, which, in turn, will translate into more rapid, economical health care, and improved psychosocial well-being of the patient. If these hypotheses are correct, the results are expected to provide evidence based research data to support early loading and immediate loading of single implants in sites of adequate bone volume, and density with or without the use of graft materials in sinus lift procedures. In addition, it is expected that these results will fundamentally advance the field of implant dentistry and bioengineering by providing information on the principles of the bone density-mechanical environment-implant stability interaction.
Detailed description
Specific Aims
Primary Outcome Measures:
- The objective of this study is to allow a preliminary analysis of the resonance frequency values over the 12 month period, which will be the primary outcome
Secondary Outcome Measures:
- To assess Crestal bone level maintenance
Study Arms Bone Augmentation: Placement of two dental implants in Sinus augmented with Puros Cortico-Cancellous Particulate Allograft (70% Cortico and 30% Cancelleous) (Zimmer Dental- Carlsbad, CA, USA)- one implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the initial insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement.
Sinus Elevation only: Placement of two dental implants as mentioned above in sinus augmented by sinus elevation procedure, blood clot and CopiOs Pericardium Membrane (Zimmer Dental- Carlsbad, CA, USA) only. One implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bone Augmention | Active comparator | Device: Two implant designs in a Sinus Bone Augmentation ProcedureTwo implant designs in a Sinus Bone Augmentation Procedure. Sinus bone augmentation with Puros Cortico-Cancellous Particulate Allograft (70% Cortico and 30% Cancelleous) (Zimmer Dental- Carlsbad, CA, USA)- one implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the initial insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. |
| Sinus elevation only | Active comparator | Device: Two implant designs in a Sinus Floor Elevation ProcedureTwo implant designs in a Sinus Floor Elevation Procedure. Placement of two dental implants as mentioned above in sinus bone augmentation by sinus elevation procedure, blood clot and CopiOs Pericardium Membrane (Zimmer Dental- Carlsbad, CA, USA) only. One implant will be TMDI (Zimmer Dental- Carlsbad, CA, USA) and the second will be Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA). Implant stability will be determined by the insertion torque and RFV values at time of implant placement and after 1 month of healing on a monthly basis up until 12 months post implant placement. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- • The subject male or female between 21-75 years of age and has:
Key exclusion criteria (24 listed)
- Subjects who have smoked cigarettes or chewed tobacco within the past year
- History of alcoholism or drug abuse within the past 5 years
- Subjects with Severe bruxing or clenching habits
- Untreated periodontitis
- Subjects at undue risk for an outpatient surgical procedure
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 |
|---|---|---|
| Two implant designs in a Sinus Bone Augmentation ProcedureComparing TMDI (Zimmer Dental- Carlsbad, CA, USA) and Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA) biological behavior after a sinus bone augmentation procedure. | Device | Bone Augmention |
| Two implant designs in a Sinus Floor Elevation ProcedureComparing TMDI (Zimmer Dental- Carlsbad, CA, USA) and Tapered Screw-Vent TSV-MTX (Zimmer Dental- Carlsbad, CA,USA) biological behavior after a sinus elevation only procedure. | Device | Sinus elevation only |
Primary outcome
Resonance Frequency Values of Dental Implants
Time frame: 8 months
Implant stability quotient (ISQ) is the value on a scale that indicates the level of stability and osseointegration in dental implants. The scale ranges from 1 to 100 and is measured by implant stability meters instruments using resonance frequency analysis (RFA) technique. The acceptable stability range lies between 55-85 ISQ. Lower initial stability will normally increase with time due to the lower mechanical stability being enforced by the bone remodeling process (osseointegration). The overall average ISQ value of all implants over time is approximately 70. A significant decrease in ISQ indicates a potential problem and should be considered an early warning. For each time period three measurements were taken from three different positions on the dental implant and the measurements were averaged for each time period.
1 secondary outcome
Crestal Bone Levels
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Kevin Guze, DMD DMSc MSc principal investigator
Harvard School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Two implant designs in a Sinus Bone Augmentation Procedure and Two implant designs in a Sinus Floor Elevation Procedure in people with Atrophy of Edentulous Alveolar Ridge and Partial Edentulism, run by Harvard Medical School (HMS and HSDM) at 1 site 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 8 inclusion and 24 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 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 6 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Resonance Frequency Values of Dental Implants (time frame: 8 months). 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 22 Jul 2020.