NCT01821417

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2011

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2015

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

March 16, 2017

Completed
Last Updated

March 16, 2017

Status Verified

January 1, 2017

Enrollment Period

3.1 years

First QC Date

March 13, 2013

Results QC Date

July 29, 2015

Last Update Submit

January 26, 2017

Conditions

Partially Edentulous Jaw

Keywords

dental implantsscrew-vent dental implants

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Changes in Peri-implant Gingivitis Score

    1 year after placement

  • Millimeters of Periodontal Pocket Depth Surrounding the Dental Implant Device

    1 year after placement

Study Arms (2)

Microtextured dental implant

EXPERIMENTAL

Randomized for microtextured dental implant treatment

Device: Microtextured dental implant treatment

Dental implant

ACTIVE COMPARATOR

Randomized dental implant treatment with machined-collar implants

Device: Dental implant treatment

Interventions

Microtextured dental implant treatmentDEVICE

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.

Also known as: Screw-vent dental implant
Microtextured dental implant
Dental implant treatmentDEVICE

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.

Dental implant

Eligibility Criteria

Age19 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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 read and understand the informed consent form
  • Demonstrated willingness to comply with protocol requirements and timeline

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alabama at Birmingham School of Dentistry

Birmingham, Alabama, 35294-0007, United States

Location

MeSH Terms

Conditions

Jaw, Edentulous, Partially

Condition Hierarchy (Ancestors)

Jaw, EdentulousJaw DiseasesMusculoskeletal DiseasesStomatognathic DiseasesMouth, EdentulousMouth DiseasesTooth Diseases

Results Point of Contact

Title
Nicolaas C. Geurs, DDS MS
Organization
University of Alabama at Birmingham
ngeurs@uab.edu
2059344506

Study Officials

  • Nicolaas C. Geurs, DDS.MS

    University of Alabama at Birmingham

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 13, 2013

First Posted

April 1, 2013

Study Start

May 1, 2011

Primary Completion

June 1, 2014

Study Completion

October 1, 2015

Last Updated

March 16, 2017

Results First Posted

March 16, 2017

Record last verified: 2017-01

Locations

US(1)