NCT00759031

Brief Summary

Investigation of inhibitory effect of prototype toothpaste on dental plaque formation via modified gingival margin plaque index method.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
19

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2008

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

February 1, 2008

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2008

Completed
7 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 25, 2008

Completed
Last Updated

April 13, 2012

Status Verified

April 1, 2012

Enrollment Period

29 days

First QC Date

September 23, 2008

Results QC Date

October 16, 2008

Last Update Submit

April 11, 2012

Conditions

Dental Plaque

Outcome Measures

Primary Outcomes (1)

  • Gingival Margin Plaque Index

    Scale 0 to 100% of tooth gingival margin covered by plaque. (0=no plaque, 100%=100% of the tooth's gingival margin is covered in plaque). The lower the score less dental plaque is present along the gum line and therefore the better the performance of the study treatment.

    1 day

Study Arms (2)

A - Marketed fluoride toothpaste

PLACEBO COMPARATOR
Drug: Sodium Monofluorophosphate

B -Triclosan/NaF/CoPolymer toothpaste

ACTIVE COMPARATOR
Drug: Triclosan/Fluoride/Copolymer

Interventions

Sodium MonofluorophosphateDRUG

Brush teeth and evaluate plaque score after one use of the study toothpaste

Also known as: Colgate Great Regular Flavor toothpaste
A - Marketed fluoride toothpaste
Triclosan/Fluoride/CopolymerDRUG

Brush teeth and evaluate plaque score after one use of the study toothpaste

Also known as: Colgate Total toothpaste
B -Triclosan/NaF/CoPolymer toothpaste

Eligibility Criteria

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

You may qualify if:

  • Be aged 18 to 65 years inclusive
  • Have a minimum of 20 natural uncrowned teeth (excluding 3rd molars) present
  • Give written informed consent
  • Be in good general health
  • Must discontinue oral hygiene for 24-hrs.after initial appointment.
  • No known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the dental/medical professional monitoring the study

You may not qualify if:

  • Medical condition which requires pre-medication prior to dental visits/procedures
  • Advanced periodontal disease
  • or more decayed, untreated dental sites
  • Diseases of the soft or hard oral tissues
  • Orthodontic appliances
  • Abnormal salivary function
  • Use of drugs that can currently affect salivary flow
  • Use of antibiotics one (1) month prior to or during this study
  • Use of any over the counter medications other than analgesics (i.e. aspirin, ibuprofen, acetaminophen, naproxyn)
  • Pregnant or breastfeeding.
  • Participation in another clinical study in the month preceding this study
  • Allergic to common dentifrice ingredients.
  • Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Boston University School of Dental Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Dental Plaque

Interventions

fluorophosphateTriclosanhydrated silica gel-based toothpaste

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Phenyl 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

  • 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
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2008

First Posted

September 25, 2008

Study Start

February 1, 2008

Primary Completion

March 1, 2008

Study Completion

March 1, 2008

Last Updated

April 13, 2012

Results First Posted

November 25, 2008

Record last verified: 2012-04

Locations

US(1)