The Effect of Periodontal Treatment and the Use of Dentifrice on Glycaemic Control in Diabetics

July 10, 2015 updated by: Colgate Palmolive
To test effectiveness of dentifrice in maintaining periodontal health.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
      • Queensland, Australia
        • Logan Hospital Oral Health Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Poor glycaemic control as evidenced by an HbA1c of >6.0% for the past 12 months
  • Aged 18 to 75 years
  • Able to give informed consent
  • Minimum of 12 teeth
  • Chronic periodontitis as indicated by periodontal probing depths >5mm on at least 6 teeth

Exclusion Criteria:

  • Pregnancy
  • Gross dental caries
  • Prosthetic heart valves, a history of infective endocarditis or any other condition requiring antibiotic cover for dental treatment (rheumatic fever, mitral valve prolapse with regurgitation)
  • Anticoagulant therapy (excluding asprin)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: A
Drug: Triclosan, Fluoride
subjects brushed their teeth twice daily with the study toothpaste for the assigned treatment period.
Other Names:
  • triclosan/fluoride/copolymer toothpaste
PLACEBO_COMPARATOR: B
Drug: Fluoride
subjects brushed their teeth twice daily with the study toothpaste for the assigned study treatment period.
Other Names:
  • current marketed fluoride only toothpaste

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
HbA1c Levels in Blood
Time Frame: 12 months
Glycated hemoglobin (HbA1c) is a form of hemoglobin which is measured primarily to identify the average plasma glucose concentration over prolonged periods of time. In this study, blood is taken from each subject and HbA1c levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS).
12 months
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. Blood is taken from each subject and CRP levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS).
12 months
C-Peptide
Time Frame: 12 months
C-Peptide levels in blood indicate whether or not a person is producing insulin. This peptide is usually found in equal levels to insulin. C-peptide levels measured as a means of distinguishing type 1 diabetes and type 2 diabetes. Blood is taken from each subject and C-Peptide levels were measured at 12 months by Queensland Health Pathology Scientific Services (QHPSS).
12 months
Gingivitis Score (GI)
Time Frame: 12 months

Units on a scale 0 to 3 (0 = no inflammation,

1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)
12 months
P. Gingivalis
Time Frame: 12 months
Subgingival plaque samples were collected from all interproximal (mesial) sites and pooled prior to assessment. The samples will be analysed for the presence of P. gingivalis, using real time PCR to quantitate the numbers of bacteria. P. gingivalis is a non-motile, gram negative, anaerobic, pathogenic bacteria. It is linked to periodontal disease and causes collagen degradation.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colgate Palmolive

Investigators

  • Principal Investigator: Gregory Seymour, BDS, University of Otago

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2006

Primary Completion (ACTUAL)

August 1, 2009

Study Completion (ACTUAL)

August 1, 2009

Study Registration Dates

First Submitted

September 26, 2008

First Submitted That Met QC Criteria

September 29, 2008

First Posted (ESTIMATE)

September 30, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

July 28, 2015

Last Update Submitted That Met QC Criteria

July 10, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2004000841/2004/201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe