NCT00762762

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Mar 2006

Typical duration for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2006

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 30, 2008

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
3.4 years until next milestone

Results Posted

Study results publicly available

April 26, 2012

Completed
Last Updated

March 3, 2023

Status Verified

April 1, 2012

Enrollment Period

2.8 years

First QC Date

September 26, 2008

Results QC Date

April 2, 2012

Last Update Submit

February 6, 2023

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (5)

  • HbA1c Levels in Blood

    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.

    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.

    12 months

  • C-Peptide

    C-Peptide levels in blood indicate whether or not a person is producing insulin

    12 months

  • IL-6 (Interleukin - 6)

    Levels of Interleukin - 6 (GCF IL-6) found in blood drawn from subjects. Indication of systemic inflammation in the body.(weight in picograms)

    12 months

  • TNF-α (Tumor Necrosis Factor - Alpha)

    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.

    12 months

Study Arms (2)

Total toothpaste

ACTIVE COMPARATOR

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

Drug: Triclosan/copolymer/fluoride

Fluoride mouthrinse

PLACEBO COMPARATOR

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

Drug: Fluoride

Interventions

Triclosan/copolymer/fluorideDRUG

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.

Also known as: Total toothpaste
Total toothpaste
FluorideDRUG

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.

Also known as: Fluorigard oral rinse
Fluoride mouthrinse

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Any condition requiring antibiotic cover for dental treatment
  • Other serious illness

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Periodontitis

Interventions

Triclosanhydrated silica gel-based toothpasteFluorides

Condition Hierarchy (Ancestors)

Periodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Phenyl EthersEthersOrganic ChemicalsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsAnionsIonsElectrolytesInorganic ChemicalsHydrofluoric AcidFluorine 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, PhD

    Otago University

    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
SINGLE
Who Masked
PARTICIPANT
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

March 1, 2006

Primary Completion

December 1, 2008

Study Completion

December 1, 2008

Last Updated

March 3, 2023

Results First Posted

April 26, 2012

Record last verified: 2012-04

Data Sharing

IPD Sharing
Will not share