Effectiveness of a Triclosan Containing Toothpaste in Maintaining Periodontal Health in a Type 2 Diabetic Population

Phase 3

Completed

• Conditions: Periodontitis
• Interventions: Drug: Fluoride; Drug: Triclosan/copolymer/fluoride

• Registration Number: NCT00762762
• Lead Sponsor: Colgate Palmolive

Brief Summary

Clinical research study to determine the effectiveness of a triclosan/copolymer/fluoride toothpaste in maintaining periodontal health and therefore glycaemic control in a type 2 diabetic population.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-03
• Study First Submitted: 2008-09-26
• Study First Submitted QC: 2008-09-26
• Study First Posted: 2008-09-30
• Primary Completion: 2008-12
• Study Completion: 2008-12
• Status Verified: 2012-04
• Results First Submitted: 2012-04-02
• Results First Submitted QC: 2012-04-02
• Results First Posted: 2012-04-26
• Last Update Submitted: 2023-02-06
• Last Update Posted: 2023-03-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluoride mouthrinse	Fluoride	Swish whole mouth 2x/day for 12 months with fluoride mouthrinse.
Total toothpaste	Triclosan/copolymer/fluoride	Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste.

Primary Outcome Measures

Name	Time	Method
HbA1c Levels in Blood	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.
C-Peptide	12 months	C-Peptide levels in blood indicate whether or not a person is producing insulin
TNF-α (Tumor Necrosis Factor - Alpha)	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.
IL-6 (Interleukin - 6)	12 months	Levels of Interleukin - 6 (GCF IL-6) found in blood drawn from subjects. Indication of systemic inflammation in the body.(weight in picograms)
High Sensitivity CRP (C-Reactive Protein)	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.