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

NCT00763256 | Completed Phase 3 Results DMC

• 1 other identifier: 2004000841/2004/201
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

To test effectiveness of dentifrice in maintaining periodontal health.

Conditions

Periodontal Disease

Outcome Measures

Primary Outcomes (5)

• HbA1c Levels in Blood

  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)

  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

  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)

  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

  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

Study Arms (2)

A

ACTIVE COMPARATOR

Drug: Triclosan, Fluoride

B

PLACEBO COMPARATOR

Drug: Fluoride

Interventions

Triclosan, Fluoride DRUG

subjects brushed their teeth twice daily with the study toothpaste for the assigned treatment period.

Also known as: triclosan/fluoride/copolymer toothpaste

A

Fluoride DRUG

subjects brushed their teeth twice daily with the study toothpaste for the assigned study treatment period.

Also known as: current marketed fluoride only toothpaste

B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

Logan Hospital Oral Health Clinic

Queensland, Australia

Location

MeSH Terms

Conditions

Periodontal Diseases

Interventions

Triclosan; Fluorides

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Phenyl Ethers; Ethers; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrofluoric Acid; Fluorine Compounds

Results Point of Contact

• Title: William DeVizio, DMD
• Organization: Colgate Palmolive Co.

william_devizio@colpal.com

732-878-7901

Study Officials

• Gregory Seymour, BDS

  University of Otago

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: September 30, 2008
• Study Start: May 1, 2006
• Primary Completion: August 1, 2009
• Study Completion: August 1, 2009
• Last Updated: July 28, 2015
• Results First Posted: April 2, 2012

Record last verified: 2015-07

Locations

AU (1)