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
  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:


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 April 17, 2014