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Healing Profile of Titanium Dental Implants Placed in Patients With Diabetes

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00971516
First Posted: September 3, 2009
Last Update Posted: May 8, 2012
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. Read our disclaimer for details.
Collaborators:
University of Manitoba
University of Toronto
Information provided by (Responsible Party):
Getulio Nogueira, University of Toronto
  Purpose

The main goal of this study is to look at the way gums heal around dental implants placed in healthy patients compared to patients with type 2 diabetes. This study is designed to answer the following questions:

  • How much swelling occurs around dental implants placed in patients with type 2 diabetes?
  • Is swelling (inflammation) present or absent in the initial healing phase after placement of dental implants?
  • What are the differences in the amount of swelling (inflammation) in patients with and without type 2 diabetes? Are patients with type 2 diabetes more likely to have bone loss around dental implants?

Condition Intervention
Type 2 Diabetes Dental Implants Procedure: Implant placement Procedure: Implants surgery

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Healing Profile of Titanium Dental Implants Placed in Patients With Type 2 Diabetes: a Prospective Osteoimmunological and Clinical Pilot Study

Further study details as provided by Getulio Nogueira, University of Toronto:

Primary Outcome Measures:
  • Healing profile of cytokines [ Time Frame: 1 year ]

Estimated Enrollment: 20
Study Start Date: October 2009
Study Completion Date: May 2012
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Diabetes
compare cytokines between diabetes and non diabetes patients
Procedure: Implants surgery
dental implant surgery
Other Name: diabetes patients
Active Comparator: Implants
Compare implant healing phases
Procedure: Implant placement
dental implant placement
Other Name: Dental implants
Procedure: Implants surgery
dental implant surgery
Other Name: diabetes patients

  Show Detailed Description

  Eligibility

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.


Ages Eligible for Study:   35 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Type 2 diabetes patients and with partial edentulism.

Exclusion Criteria:

  • Active periodontal disease,
  • Uncontrolled diabetes,
  • Smokers,
  • Any metabolic bone diseases or other systemic disorders.
  Contacts and Locations
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): NCT00971516


Sponsors and Collaborators
Escola Bahiana de Medicina e Saude Publica
University of Manitoba
University of Toronto
Investigators
Principal Investigator: Getulio R Nogueira F University of Manitoba
  More Information

Responsible Party: Getulio Nogueira, Assistant Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT00971516     History of Changes
Other Study ID Numbers: IMPL900209-01
First Submitted: September 2, 2009
First Posted: September 3, 2009
Last Update Posted: May 8, 2012
Last Verified: May 2012

Keywords provided by Getulio Nogueira, University of Toronto:
diabetes
implants
cytokines

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases