Performance of MicroTextured Dental Implants

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Zimmer Dental
Information provided by (Responsible Party):
University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT01821417
First received: March 13, 2013
Last updated: September 14, 2014
Last verified: September 2014
  Purpose

The study will compare initial peri-implant bone healing and longitudinal osseointegration between a fully microtextured dental implant and an analogous implant with a smooth machined collar.

The investigators hypothesize the fully textured implant will result in less peri-implant crestal bone resorption than the implant with a machined collar.


Condition Intervention
Partially Edentulous Jaw
Device: Microtextured dental implant treatment
Device: Dental implant treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial to Assess the Performance of MicroTextured Dental Implants With or Without a Machined Collar

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:
  • Change in millimeters of bone loss surrounding the implant device [ Time Frame: Implant insertion, 12 months post-insertion ] [ Designated as safety issue: Yes ]
    Using radiographic images and image-processing software, measurements of bone height at the mesial and distal of each implant will be captured in millimeters.


Secondary Outcome Measures:
  • Millimeters of periodontal pocket depth surrounding the implant device [ Time Frame: 2 months post- implant insertion ] [ Designated as safety issue: Yes ]
    Millimeters of pocket depth will be measured with a periodontal probe at four sites around each implant, distal, buccal, mesial, lingual.

  • Changes in peri-implant gingivitis scores [ Time Frame: implant insertion, 12 months post-insertion ] [ Designated as safety issue: No ]
    A clinical examination utilizing a standard "gingival index" score will measure the amount of existing gingival inflammation


Estimated Enrollment: 60
Study Start Date: May 2011
Estimated Study Completion Date: October 2015
Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Microtextured dental implant
Randomized for microtextured dental implant treatment
Device: Microtextured dental implant treatment
Microtextured dental implant treatment will include a surgically inserted device implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists.
Other Name: Screw-vent dental implant
Active Comparator: Dental implant
Randomized dental implant treatment with machined-collar implants
Device: Dental implant treatment
Treatment with dental implants; implants with a machined collar will be surgically implanted into edentulous areas of the jaw where natural teeth have been lost and adequate bone exists.

Detailed Description:

Zimmer dental has developed a microtextured tapered screw-vent implant design with a titanium skin that has been grit-blasted with hydroxyapatite particles resulting in an overall roughened surface, which, when compared to an implant with a machined (smooth) collar (narrow band around the top of the device) surface is thought to increase the apposition of osseous tissue integration and to promote epithelial attachment to the implant device.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Be a current registered University of Alabama at Birmingham (UAB)dental school patient
  2. Existence of one or more missing teeth scheduled to be replaced with dental implants
  3. Healthy enough to undergo proposed therapy without compromising existing health
  4. Able to consent for their own inclusion
  5. Able to read and understand the informed consent form
  6. Demonstrated willingness to comply with protocol requirements and timeline

Exclusion Criteria:

  1. Any health condition that in the opinion of the investigators may adversely affect bone healing
  2. Any medication that in the opinion of the investigators may adversely affect bone healing
  3. Any indication of an inability to make autonomous decisions
  4. Reported pregnancy at the time of enrollment -
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01821417

Locations
United States, Alabama
University of Alabama at Birmingham School of Dentistry
Birmingham, Alabama, United States, 35294-0007
Sponsors and Collaborators
University of Alabama at Birmingham
Zimmer Dental
Investigators
Principal Investigator: Nicolaas C. Geurs, DDS.MS University of Alabama at Birmingham
  More Information

No publications provided

Responsible Party: University of Alabama at Birmingham
ClinicalTrials.gov Identifier: NCT01821417     History of Changes
Other Study ID Numbers: Z-11
Study First Received: March 13, 2013
Last Updated: September 14, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:
dental implants
screw-vent dental implants

Additional relevant MeSH terms:
Jaw, Edentulous
Jaw Diseases
Mouth Diseases
Mouth, Edentulous
Musculoskeletal Diseases
Stomatognathic Diseases
Tooth Diseases

ClinicalTrials.gov processed this record on October 20, 2014