NCT00758394

Brief Summary

This clinical study was to evaluate the control of dental plaque formation after toothbrushing for 4 days with each of the 4 study toothpastes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
29

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Sep 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

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

September 1, 2007

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2007

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

September 23, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 25, 2008

Completed
2 months until next milestone

Results Posted

Study results publicly available

November 19, 2008

Completed
Last Updated

August 15, 2013

Status Verified

August 1, 2013

Enrollment Period

2 months

First QC Date

September 23, 2008

Results QC Date

October 16, 2008

Last Update Submit

August 8, 2013

Conditions

Dental Plaque

Outcome Measures

Primary Outcomes (1)

  • Dental Plaque Index

    plaque units measured on a scale between 0 to 5. 0 = No plaque; 5 = 2/3 of Tooth covered in plaque.

    4-Day

Study Arms (4)

Fluoride - A

PLACEBO COMPARATOR

Fluoride only toothpaste

Drug: Fluoride

Total + Whitening toothpaste - B

ACTIVE COMPARATOR

Triclosan/fluoride toothpaste

Drug: Triclosan/Fluoride

Triclosan/fluoride/Amino Acid - C

EXPERIMENTAL

toothpaste containing amino acid #1

Drug: Triclosan/Fluoride

Triclosan/fluoride/Cavistat -D

EXPERIMENTAL

toothpaste containing amino acid/bicarbonate

Drug: Triclosan/Fluoride

Interventions

FluorideDRUG

Brush two times a day for 4 days.

Also known as: monofluorophosphate
Fluoride - A
Triclosan/FluorideDRUG

Brush two times daily for 4 days

Also known as: sodium fluoride, triclosan
Total + Whitening toothpaste - B

Eligibility Criteria

Age18 Years - 53 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female volunteers at least 18 - 53 years of age
  • Good general health
  • Must sign informed consent form
  • Minimum of 20 natural uncrowned teeth (excluding third molars) must be present.
  • No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study.

You may not qualify if:

  • Subjects unable or unwilling to sign the informed consent form.
  • Medical condition which requires pre-medication prior to dental visits/procedures
  • Moderate or advanced periodontal disease or heavy dental tartar (calculus).
  • or more decayed untreated dental sites at screening.
  • Other disease of the hard or soft oral tissues.
  • Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
  • Use of medications that are currently affecting salivary function
  • Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
  • Pregnant or nursing women.
  • Participation in any other clinical study within 1 week prior to enrollment into this study.
  • Use of tobacco products
  • Subjects who must receive dental treatment during the study dates.
  • Current use of Antibiotics for any purpose.
  • Presence of an orthodontic appliance which interferes with plaque scoring.
  • History of allergy to common dentifrice ingredients.
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bluestone Center for Clinical Research, NYU College of Dentistry

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Dental Plaque

Interventions

FluoridesfluorophosphateTriclosanSodium FluorideAmino Acids

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

AnionsIonsElectrolytesInorganic ChemicalsHydrofluoric AcidFluorine CompoundsPhenyl EthersEthersOrganic ChemicalsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsSodium CompoundsCariostatic AgentsBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and AgricultureAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
William DeVizio - DMD
Organization
Colgate Palmolive
william_devizio@colpal.com
732-878-7901

Study Officials

  • Patricia Corby, DDS

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 23, 2008

First Posted

September 25, 2008

Study Start

September 1, 2007

Primary Completion

November 1, 2007

Study Completion

November 1, 2007

Last Updated

August 15, 2013

Results First Posted

November 19, 2008

Record last verified: 2013-08

Locations

US(1)