NCT01014143

Brief Summary

Clinical research study to determine the anti-plaque efficacy of commerical dentifrices and an oral rinse.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Aug 2007

Shorter than P25 for phase_2

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

August 1, 2007

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

September 26, 2008

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

November 16, 2009

Completed
Same day until next milestone

Results Posted

Study results publicly available

November 16, 2009

Completed
Last Updated

June 14, 2011

Status Verified

June 1, 2011

Enrollment Period

1 month

First QC Date

September 26, 2008

Results QC Date

September 26, 2008

Last Update Submit

June 10, 2011

Conditions

Dental Plaque

Outcome Measures

Primary Outcomes (1)

  • Plaque Index

    Plaque scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque,3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)

    Four days

Study Arms (3)

Fluoride toothpaste

PLACEBO COMPARATOR

Negative control

Drug: Fluoride

Triclosan/Fluoride toothpaste

ACTIVE COMPARATOR

positive control toothpaste

Drug: Fluoride, triclosan

Chlorhexidine Oral Rinse

ACTIVE COMPARATOR

Positive Control mouthrinse

Drug: Chlorhexidine digluconate

Interventions

FluorideDRUG

Half mouth toothbrushing twice a day for four days.

Also known as: fluoride toothpaste
Fluoride toothpaste
Chlorhexidine digluconateDRUG

Mouth rinsing with 15 ml for 30 seconds twice a day for four days.

Also known as: Periogard oral rinse
Chlorhexidine Oral Rinse
Fluoride, triclosanDRUG

Half mouth Brushing twice daily

Also known as: Total toothpaste
Triclosan/Fluoride toothpaste

Eligibility Criteria

Age23 Years - 81 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female volunteers at least 18 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).
  • Two 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 affect salivary function.
  • Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
  • Allergy to chlorhexidine.
  • 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 pre-medication for dental treatment or for any other purpose.
  • Presence of an orthodontic appliance that interferes with plaque scoring.
  • +2 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New Institutional Service Company

Northfield, New Jersey, 08225, United States

Location

MeSH Terms

Conditions

Dental Plaque

Interventions

Fluorideschlorhexidine gluconateTriclosanhydrated silica gel-based toothpaste

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

AnionsIonsElectrolytesInorganic ChemicalsHydrofluoric AcidFluorine CompoundsPhenyl EthersEthersOrganic ChemicalsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbons

Results Point of Contact

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

Study Officials

  • Matthew Cronin, DDS

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 26, 2008

First Posted

November 16, 2009

Study Start

August 1, 2007

Primary Completion

September 1, 2007

Study Completion

September 1, 2007

Last Updated

June 14, 2011

Results First Posted

November 16, 2009

Record last verified: 2011-06

Locations

US(1)