Completed

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

What is being tested

Microtextured dental implant treatment

+ Dental implant treatment

Device

Who is being recruted

Jaw Diseases+5

+ Jaw, Edentulous

+ Stomatognathic Diseases

Over 19 Years

+10 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Treatment Study

Interventional

Study Start: May 2011

See protocol details

Summary

Principal SponsorUniversity of Alabama at Birmingham

Last updated: March 16, 2017

Sourced from a government-validated database.Claim as a partner

Study start date: May 1, 2011

Actual date on which the first participant was enrolled.

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.

NCT01821417

Principal SponsorUniversity of Alabama at Birmingham

Last updated: March 16, 2017

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

68 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Conditions

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 19 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Jaw DiseasesJaw, EdentulousStomatognathic DiseasesMouth DiseasesMouth, EdentulousMusculoskeletal DiseasesTooth DiseasesJaw, Edentulous, Partially

Criteria

6 inclusion criteria required to participate

Able to consent for their own inclusion

Able to read and understand the informed consent form

Be a current registered University of Alabama at Birmingham (UAB)dental school patient

Demonstrated willingness to comply with protocol requirements and timeline

Show More Criteria

4 exclusion criteria prevent from participating

Any health condition that in the opinion of the investigators may adversely affect bone healing

Any indication of an inability to make autonomous decisions

Any medication that in the opinion of the investigators may adversely affect bone healing

Reported pregnancy at the time of enrollment -

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Treatment Groups

Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group

Treatment Groups

Group I

Experimental

Randomized for microtextured dental implant treatment

Group II

Active Comparator

Randomized dental implant treatment with machined-collar implants

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Alabama at Birmingham School of Dentistry

Birmingham, United StatesOpen University of Alabama at Birmingham School of Dentistry in Google Maps

CompletedOne Study Center