ClinicalTrials.gov
ClinicalTrials.gov Menu

Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants After Sinus Floor Elevation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02404649
Recruitment Status : Completed
First Posted : March 31, 2015
Results First Posted : October 6, 2016
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
Kevin Guze, Harvard Medical School

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.

Condition or disease Intervention/treatment Phase
Atrophy of Edentulous Alveolar Ridge Partial Edentulism Device: Two implant designs in a Sinus Bone Augmentation Procedure Device: Two implant designs in a Sinus Floor Elevation Procedure Not Applicable

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 bone maturation, crestal bone level maintenance, and implant survival over two years

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. Thickness of bone surrounding implant body positioned in the sinus will be measured.

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective Clinical Trial Comparing Conventional Dental Implants and Trabecular Metal™ Dental Implants After Staged Sinus Floor Elevation Procedures
Study Start Date : July 2012
Actual Primary Completion Date : October 2014
Actual Study Completion Date : December 2017

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. Thickness of bone surrounding implant body positioned in the sinus will be measured.
Device: Two 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.

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. Thickness of bone surrounding implant body positioned in the sinus will be measured.
Device: Two 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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Level of Bone Maturation [ Time Frame: 2 years ]
  2. Evaluate Crestal Bone Levels [ Time Frame: 2 years ]
  3. To Assess Implant Survival [ Time Frame: 2 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   21 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02404649


Locations
United States, Massachusetts
Harvard School of Dental Medicine
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Harvard Medical School
Investigators
Principal Investigator: Kevin Guze, DMD DMSc MSc Harvard School of Medicine

Responsible Party: Kevin Guze, Clinical Instructor, Harvard Medical School
ClinicalTrials.gov Identifier: NCT02404649     History of Changes
Other Study ID Numbers: HarvardMS
First Posted: March 31, 2015    Key Record Dates
Results First Posted: October 6, 2016
Last Update Posted: August 31, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Atrophy
Pathological Conditions, Anatomical