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

NCT ID: NCT00762762

Last Updated: 2023-03-03

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-03-31

Study Completion Date

2008-12-31

Brief Summary

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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

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Conditions

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Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Total toothpaste

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

Group Type ACTIVE_COMPARATOR

Triclosan/copolymer/fluoride

Intervention Type DRUG

Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses.

Fluoride mouthrinse

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

Group Type PLACEBO_COMPARATOR

Fluoride

Intervention Type DRUG

Swished around whole mouth twice daily for 12 months. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses.

Interventions

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Triclosan/copolymer/fluoride

Brush whole mouth 2x/day for 12 months with triclosan/copolymer/fluoride toothpaste. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses.

Intervention Type DRUG

Fluoride

Swished around whole mouth twice daily for 12 months. Return for required clinical visits @ 12 months for scaling, root planing and donation samples of dental plaque and blood for microbiological analyses.

Intervention Type DRUG

Other Intervention Names

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Total toothpaste Fluorigard oral rinse

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Colgate Palmolive

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gregory Seymour, BDS, PhD

Role: PRINCIPAL_INVESTIGATOR

Otago University

Other Identifiers

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2004000685

Identifier Type: -

Identifier Source: org_study_id

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