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Investigate Plaque and Gingival Index

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ClinicalTrials.gov Identifier: NCT00762762
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : April 26, 2012
Last Update Posted : April 26, 2012
Sponsor:
Information provided by (Responsible Party):
Colgate Palmolive

Study Description
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Brief Summary:
Clinical research study to determine the anti-plaque efficacy of commerical dentifrices.

Condition or disease Intervention/treatment Phase
Periodontitis Drug: Triclosan and fluoride Drug: Fluoride Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Investigate Plaque and Gingival Index
Study Start Date : March 2006
Actual Primary Completion Date : December 2008
Actual Study Completion Date : December 2008

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Arms and Interventions
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Arm Intervention/treatment
Active Comparator: A Drug: Triclosan and fluoride
Brush twice daily
Other Name: triclosan/fluoride/copolymer toothpaste
Placebo Comparator: B Drug: Fluoride
swished twice daily
Other Name: Anti-cavitiy fluoride oral rinse


Outcome Measures
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Primary Outcome Measures :
  1. HbA1c Levels in Blood [ Time Frame: 12 months ]
    Blood is taken from each subject and HbA1c levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS). This test measures the glycated hemoglobin in the blood.

  2. High Sensitivity CRP (C-Reactive Protein) [ Time Frame: 12 months ]
    CRP is a protein found in the blood and is a marker for inflammation in the body. Inflammation plays a role in the initiation and progression of cardiovascular disease.

  3. C-Peptide [ Time Frame: 12 months ]
    C-Peptide levels in blood indicate whether or not a person is producing insulin

  4. IL-6 (Interleukin - 6) [ Time Frame: 12 months ]
    Levels of Interleukin - 6 (GCF IL-6) found in blood drawn from subjects. Indication of systemic inflammation in the body.(weight in picagrams)

  5. TNF-α (Tumor Necrosis Factor - Alpha) [ Time Frame: 12 months ]
    Blood drawn from subjects to determine the level of TNF-α (Tumor necrosis factor - alpha). TNF-α is a pleiotropic inflammatory cytokine involved in systemic inflammation.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Type 2 diabetes with poor glycaemic control as evidenced by random blood glucose of >200mg/dl.
  • Minimum of 16 teeth
  • Chronic periodontitis as indicated by periodontal probing depths >4mm on at least 6 teeth

Exclusion Criteria:

  • Any condition requiring antibiotic cover for dental treatment
  • Other serious illness
Contacts and Locations
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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): NCT00762762


Locations
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Australia
Republic of Marshall Islands
Queensland, Australia
Sponsors and Collaborators
Colgate Palmolive
Investigators
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Principal Investigator: Gregory Seymour, BDS, PhD Otago University
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Colgate Palmolive
ClinicalTrials.gov Identifier: NCT00762762    
Other Study ID Numbers: 2004000685
First Posted: September 30, 2008    Key Record Dates
Results First Posted: April 26, 2012
Last Update Posted: April 26, 2012
Last Verified: April 2012
Additional relevant MeSH terms:
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Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Triclosan
Fluorides
Cariostatic Agents
Protective Agents
 Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents