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Healing Profile of Titanium Dental Implants Placed in Patients With Diabetes

This study has been completed.
Sponsor:
Collaborators:
University of Manitoba
University of Toronto
Information provided by (Responsible Party):
Getulio Nogueira, University of Toronto
ClinicalTrials.gov Identifier:
NCT00971516
First received: September 2, 2009
Last updated: May 5, 2012
Last verified: May 2012
History of Changes
  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 Blind (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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Escola Bahiana de Medicina e Saude Publica:

Primary Outcome Measures:
  • Healing profile of cytokines [ Time Frame: 1 year ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   35 Years to 65 Years
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Getulio Nogueira, Assistant Professor, University of Toronto
ClinicalTrials.gov Identifier: NCT00971516     History of Changes
Other Study ID Numbers: IMPL900209-01
Study First Received: September 2, 2009
Last Updated: May 5, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Escola Bahiana de Medicina e Saude Publica:
diabetes
implants
cytokines

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

ClinicalTrials.gov processed this record on May 19, 2013