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Performance of MicroTextured Dental Implants

Primary Purpose

Partially Edentulous Jaw

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Microtextured dental implant treatment
Dental implant treatment
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Partially Edentulous Jaw focused on measuring dental implants, screw-vent dental implants

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 -

Sites / Locations

  • University of Alabama at Birmingham School of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Microtextured dental implant

Dental implant

Arm Description

Randomized for microtextured dental implant treatment

Randomized dental implant treatment with machined-collar implants

Outcomes

Primary Outcome Measures

Change in Millimeters of Bone Loss Surrounding the Implant Device
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

Changes in Peri-implant Gingivitis Score
Measurement of changes in peri-implant gingivitis score [Loe and Silness gingival index (GI)] after implant restoration
Millimeters of Periodontal Pocket Depth Surrounding the Dental Implant Device
Probing pocket depth (PD) is measured from the mucosal sulcus to the depth of the pocket attachment after implant restoration.

Full Information

First Posted
March 13, 2013
Last Updated
January 26, 2017
Sponsor
University of Alabama at Birmingham
Collaborators
Zimmer Dental
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1. Study Identification

Unique Protocol Identification Number
NCT01821417
Brief Title
Performance of MicroTextured Dental Implants
Official Title
A Randomized Clinical Trial to Assess the Performance of MicroTextured Dental Implants With or Without a Machined Collar
Study Type
Interventional

2. Study Status

Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
June 2014 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Zimmer Dental

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Partially Edentulous Jaw
Keywords
dental implants, screw-vent dental implants

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Microtextured dental implant
Arm Type
Experimental
Arm Description
Randomized for microtextured dental implant treatment
Arm Title
Dental implant
Arm Type
Active Comparator
Arm Description
Randomized dental implant treatment with machined-collar implants
Intervention Type
Device
Intervention Name(s)
Microtextured dental implant treatment
Other Intervention Name(s)
Screw-vent dental implant
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Dental implant treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Millimeters of Bone Loss Surrounding the Implant Device
Description
Using radiographic images and image-processing software, measurements of bone height at the mesial and distal of each implant will be captured in millimeters.
Time Frame
Implant insertion, 12 months post-insertion
Secondary Outcome Measure Information:
Title
Changes in Peri-implant Gingivitis Score
Description
Measurement of changes in peri-implant gingivitis score [Loe and Silness gingival index (GI)] after implant restoration
Time Frame
1 year after placement
Title
Millimeters of Periodontal Pocket Depth Surrounding the Dental Implant Device
Description
Probing pocket depth (PD) is measured from the mucosal sulcus to the depth of the pocket attachment after implant restoration.
Time Frame
1 year after placement

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Be a current registered University of Alabama at Birmingham (UAB)dental school patient Existence of one or more missing teeth scheduled to be replaced with dental implants Healthy enough to undergo proposed therapy without compromising existing health Able to consent for their own inclusion Able to read and understand the informed consent form Demonstrated willingness to comply with protocol requirements and timeline Exclusion Criteria: Any health condition that in the opinion of the investigators may adversely affect bone healing Any medication that in the opinion of the investigators may adversely affect bone healing Any indication of an inability to make autonomous decisions Reported pregnancy at the time of enrollment -
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolaas C. Geurs, DDS.MS
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Alabama at Birmingham School of Dentistry
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-0007
Country
United States

12. IPD Sharing Statement

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Performance of MicroTextured Dental Implants

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