Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Clinical Trial of Dental Implants in Titanium-zirconium Alloy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02681250
Recruitment Status : Recruiting
First Posted : February 12, 2016
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Vastra Gotaland Region

Brief Summary:
A Randomized controlled Clinical trial which aim is to investigate the clinical outcome of dental implants in titanium-zirconium alloy compared to traditional titan-4 implants. The hypothesis is set to no difference in the clinical outcome for the two types of implants. Preliminary estimation of 96 patients needed. A pilot study will provide us with further data in order to more accurately specify the sample number."

Condition or disease Intervention/treatment Phase
Endosseous Dental Implant Failure Procedure: Titanium-zirconium Procedure: Titanium Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized Controlled Clinical Trial of Dental Implants in Titanium-zirconium Alloy
Study Start Date : February 1, 2015
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Zirconium

Arm Intervention/treatment
Experimental: Titanium-zirconium
Patients receiving titanium-zirconium implants
Procedure: Titanium-zirconium
Titanium-zirconium implants will be installed according to the protocol earlier described in the detailed description.
Other Name: Straumann Roxolid SLA

Active Comparator: Titanium
Patients receiving titanium implants
Procedure: Titanium
Titanium implants will be installed according to the protocol earlier described in the detailed description.
Other Name: Straumann SLA (Sand blasted, Large grit, Acid Etched)




Primary Outcome Measures :
  1. Change in bone loss measured on X-ray (mm) [ Time Frame: Baseline and 1 year ]

Secondary Outcome Measures :
  1. Change in bleeding on probing (Yes/No) [ Time Frame: Baseline and 1 year ]
  2. Change in amount of Clinical Mucosa (mm) [ Time Frame: Baseline and 1 year ]
  3. Change in Pocket depth (mm) [ Time Frame: Baseline and 1 year ]
  4. Change in Prosthetic Complications (Yes/No) [ Time Frame: Baseline and 1 year ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All patients in need for implant treatment

Exclusion Criteria:

  • None

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02681250


Contacts
Layout table for location contacts
Contact: Kristina Hultin, Dentist 010-4419590 kristina.e.hultin@vgregion.se
Contact: Kostas Bougas, PhD 010-4419590 kostas.bougas@vgregion.se

Locations
Layout table for location information
Sweden
Specialisttandvården Borås Recruiting
Borås, Sweden, 50282
Sponsors and Collaborators
Vastra Gotaland Region
Investigators
Layout table for investigator information
Principal Investigator: Kostas Bougas, PhD Borås Regional Hospital
Publications:

Layout table for additonal information
Responsible Party: Vastra Gotaland Region
ClinicalTrials.gov Identifier: NCT02681250    
Other Study ID Numbers: TiZir
First Posted: February 12, 2016    Key Record Dates
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Vastra Gotaland Region:
Zirconium
Randomized Controlled Trial
Dental Implants
Dental Material
Titanium