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CompletedNCT00758290Updated Nov 25, 2008Results posted

Clinical Study to Evaluate Dental Plaque

A Phase 3 interventional study of Triclosan/Fluoride and Fluoride/triclosan in Gingival Diseases, sponsored by Colgate Palmolive. Completed at 1 site in United States. Open to participants aged 20 Years to 51 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-11-25.

Sponsored by Colgate Palmolive · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
20 Years to 51 Years
Sex
All
01

Study summary

Clinical research study to determine anti-plaque efficacy of a prototype toothpastes for a 3 week brushing regiment.

02

Conditions studied

  • Gingival Diseases
03

In context

Dental Plaque

314 studies on the registry are indexed under Dental Plaque; 54 are open to participants now.

This study's enrollment of 23 is below the median of 59 across 279 interventional studies indexed under Dental Plaque.

Browse Dental Plaque studies →

Lead sponsor

Colgate Palmolive is the lead sponsor of 114 studies on the registry; 12 are open to participants now.

Of its 33 completed or terminated interventional studies of FDA-regulated products, 2 (6%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 51 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Male or female volunteers at least 20 - 51 years of age
  • Good general health
  • Must sign informed consent form
  • Minimum of 15 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

Exclusion criteria

Exclusion Criteria:

  • 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)
  • 5 or more decayed untreated dental sites at screening (cavities)
  • 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 toothpaste ingredients
  • History of allergy to arginine (amino acid)
  • Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
23 participants (actual)

Study arms

  • Active comparator
    A

    Drug: Triclosan/Fluoride

  • Experimental
    B

    Drug: Fluoride/triclosan

Interventions

  • DrugTriclosan/Fluoride

    Brush twice daily for 3 weeks

  • DrugFluoride/triclosan

    Brush daily for 3 weeks

06

What researchers measure

Primary outcomes

  1. Dental Plaque Index

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

    Time frame: 4 Day

07

Results

Posted Nov 25, 2008

Participant flow

At clinical site

Participant flow — Overall Study
MilestoneFluoride/TriclosanTriclosan/Fluoride
Started1112
Completed1112
Not completed00

Outcome measures

PrimaryDental Plaque Index

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

Time frame:
4 Day
Reported as:
Mean · Units on a scale
Dental Plaque Index
Units on a scaleFluoride/TriclosanTriclosan/Fluoride
Dental Plaque Index2.48 ± 0.342.42 ± 0.39
Statistical analysis
  • Fluoride/Triclosan vs Triclosan/Fluoride · ANOVA · p = 0.05

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)Fluoride/TriclosanTriclosan/FluorideTotal
<=18 years000
Between 18 and 65 years111223
>=65 years000
Age Continuous
Age Continuous(years)Fluoride/TriclosanTriclosan/FluorideTotal
Mean32.5 ± 11.730.3 ± 7.131.4 ± 9.4
Sex: Female, Male
Sex: Female, Male(Participants)Fluoride/TriclosanTriclosan/FluorideTotal
Female11819
Male044
Region of Enrollment
Region of Enrollment(participants)Fluoride/TriclosanTriclosan/FluorideTotal
United States111223
08

Study locations

1 site
  • Bluestone Center for Clinical Research, NYU College of Dentistry
    New York, New York 10016, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 25, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00758290
Lead sponsor
Colgate Palmolive
First posted
Sep 25, 2008
Start date
May 2008
Primary completion
Jul 2008
Completion
Jul 2008
Results posted
Nov 25, 2008
Last update
Nov 25, 2008

Study contacts

Patricia Corby, DDS
principal investigator

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Nov 2008. You cannot join it, but the record below documents what was studied.

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