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

Colgate-Palmolive

Status and phase: Completed; Phase 3

Conditions: Periodontitis

Treatments: Drug: Triclosan/copolymer/fluoride; Drug: Fluoride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00762762

2004000685

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

Total toothpaste

Active Comparator group

Description:

Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste.

Treatment:

Drug: Triclosan/copolymer/fluoride

Fluoride mouthrinse

Placebo Comparator group

Description:

Swish whole mouth 2x/day for 12 months with fluoride mouthrinse.

Treatment:

Drug: Fluoride