Atrophy of Edentulous Alveolar Ridge, Partial Edentulism
Conditions
Brief 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. 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.
Interventions
DEVICETwo implant designs in a Sinus Bone Augmentation Procedure
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.
DEVICETwo implant designs in a Sinus Floor Elevation Procedure
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.
Sponsors
Harvard Medical School (HMS and HSDM)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
* • 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.
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resonance Frequency Values of Dental Implants | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Crestal Bone Levels | 2 years | 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. |
Countries
United States
Participant flow
Recruitment details
Recruitment of patients were fulfilled in a timely manner. Patients were were down from the existing patient pool at the Harvard School of Dental medicine.
Pre-assignment details
Three participants were excluded from the trial due to early dental implant failures. These three events were caused by local infections and thus subsequent readings were not taken.
Participants by arm
| Arm | Count |
|---|---|
| Bone Augmention 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. Thickness of bone surrounding implant body positioned in the sinus will be measured.
Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Bone Augmentation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus bone augmentation environment.
sinus bone augmentation | 16 |
| 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. Thickness of bone surrounding implant body positioned in the sinus will be measured.
Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants (Zimmer) after Staged Sinus Floor Elevation Procedures: Comparing conventional implant versus trabecular metal implant biological behavior in a sinus elevation only environment.
sinus elevation only | 14 |
| Total | 30 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 2 |
Baseline characteristics
| Characteristic | Bone Augmention | Sinus Elevation Only | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 16 Participants | 14 Participants | 30 Participants |
| Region of Enrollment United States | 16 participants | 14 participants | 30 participants |
| Sex: Female, Male Female | 9 Participants | 6 Participants | 15 Participants |
| Sex: Female, Male Male | 7 Participants | 8 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 16 | 0 / 14 |
| serious Total, serious adverse events | 0 / 16 | 0 / 14 |
Outcome results
Primary
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.
Time frame: 8 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Augmention | Resonance Frequency Values of Dental Implants | 83.04 units on a scale | Standard Deviation 3.94 |
| Sinus Elevation Only | Resonance Frequency Values of Dental Implants | 80.59 units on a scale | Standard Deviation 7.69 |
Secondary
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.
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Bone Augmention | Crestal Bone Levels | 13.05 millimeters | Standard Deviation 1.73 |
| Sinus Elevation Only | Crestal Bone Levels | 11.68 millimeters | Standard Deviation 1.4 |