Performance of MicroTextured Dental Implants

Partially Edentulous Jaw Clinical Trial

Official title:

A Randomized Clinical Trial to Assess the Performance of MicroTextured Dental Implants With or Without a Machined Collar

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01821417
• Other study ID #: Z-11
• Status: Active, not recruiting
• Phase: N/A
• First received: March 13, 2013
• Last updated: September 14, 2014
• Start date: May 2011
• Est. completion date: October 2015

Study information

• Verified date: September 2014
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: October 2015
• Est. primary completion date: June 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 -

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Jaw, Edentulous
• Partially Edentulous Jaw

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham School of Dentistry	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Zimmer Dental

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Implant insertion, 12 months post-insertion	Yes
Secondary	Millimeters of periodontal pocket depth surrounding the implant device	Millimeters of pocket depth will be measured with a periodontal probe at four sites around each implant, distal, buccal, mesial, lingual.	2 months post- implant insertion	Yes
Secondary	Changes in peri-implant gingivitis scores	A clinical examination utilizing a standard "gingival index" score will measure the amount of existing gingival inflammation	implant insertion, 12 months post-insertion	No