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

Colgate-Palmolive

Status and phase: Completed; Phase 3

Conditions: Periodontal Disease

Treatments: Drug: Fluoride; Drug: Triclosan, Fluoride

Study type: Interventional

Funder types: Industry

Identifiers

NCT00763256

2004000841/2004/201

Details and patient eligibility

About

To test effectiveness of dentifrice in maintaining periodontal health.

Enrollment: 33 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

33 participants in 2 patient groups, including a placebo group

A

Active Comparator group

Treatment:

Drug: Triclosan, Fluoride

B

Placebo Comparator group

Treatment:

Drug: Fluoride