- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02404649
Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants After Sinus Floor Elevation
A Prospective Clinical Trial Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants After Staged Sinus Floor Elevation Procedures
Study Overview
Status
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Boston, Massachusetts, United States, 02115
- Harvard School of Dental Medicine
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Bone Augmention
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.
|
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.
|
Active Comparator: Sinus elevation only
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
8 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Crestal Bone Levels
Time Frame: 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.
|
2 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Kevin Guze, DMD DMSc MSc, Harvard School of Medicine
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HarvardMS
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Partial Edentulism
-
Nobel BiocareCompletedPartial Edentulism | Complete Edentulism
-
Nobel BiocareCompletedPartial Edentulism | Complete Edentulism
-
Semmelweis UniversityInstitut Straumann AG; Geistlich Pharma AG; Dicomlab Kft.Recruiting
-
Fundación Eduardo AnituaActive, not recruitingPartial-edentulismSpain
-
Fundación Eduardo AnituaActive, not recruitingPartial-edentulismSpain
-
University of Colorado, DenverCompletedPartial EdentulismUnited States
-
University of BaghdadUnknown
-
Navigate Surgical Technologies Inc.CompletedPartial EdentulismCanada
-
Institut Straumann AGCompletedPartial EdentulismUnited States, Austria, Germany, Ireland, Netherlands, Portugal, Spain, Sweden, Switzerland
-
Institut Straumann AGCompletedPartial Edentulism
Clinical Trials on Two implant designs in a Sinus Bone Augmentation Procedure
-
Kutahya Health Sciences UniversityCompletedMaxillary Sinus Disease | Sinus DiseaseTurkey
-
Semmelweis UniversityCompletedAlveolar Bone Loss | Edentulous; Alveolar Process, Atrophy | Sinus PneumatizationHungary
-
University of MinnesotaNovaBone Products, LLCCompletedSinus Floor Augmentation | Maxillary SinusUnited States
-
Mansoura UniversityActive, not recruitingMissed Upper Posterior TeethEgypt
-
M3 HealthUniversity of GuarulhosActive, not recruitingOral Surgical ProceduresBrazil
-
University of Santiago de CompostelaFriedrich-Alexander-Universität Erlangen-NürnbergActive, not recruiting
-
Universidad de ValparaisoUniversidade Federal FluminenseRecruiting
-
Cairo UniversityUnknownDental Implant | Guided Bone Regeneration
-
Clark StanfordWithdrawn
-
Zheng LiuRecruiting