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Healing Profile of Titanium Dental Implants Placed in Patients With Diabetes

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ClinicalTrials.gov Identifier: NCT00971516
Recruitment Status : Completed
First Posted : September 3, 2009
Last Update Posted : May 8, 2012
Sponsor:
Collaborators:
University of Manitoba
University of Toronto
Information provided by (Responsible Party):
Getulio Nogueira, University of Toronto

Brief Summary:

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 or disease Intervention/treatment Phase
Type 2 Diabetes Dental Implants Procedure: Implant placement Procedure: Implants surgery Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
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
Study Start Date : October 2009
Actual Primary Completion Date : October 2010
Actual Study Completion Date : May 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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



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


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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.

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

Responsible Party: Getulio Nogueira, Assistant Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT00971516     History of Changes
Other Study ID Numbers: IMPL900209-01
First Posted: September 3, 2009    Key Record Dates
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