CompletedNCT00759031Updated Apr 13, 2012Results posted

Investigation of Dental Plaque and Gingival Index

A Phase 3 interventional study of Sodium Monofluorophosphate and Triclosan/Fluoride/Copolymer in Dental Plaque, sponsored by Colgate Palmolive. Completed at 1 site in United States. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2012-04-13.

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

Phase: Phase 3
Study type: Interventional
Enrollment: 19
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

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

Conditions studied

Dental Plaque

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Dental Plaque 314

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 19 is below the median of 59 across 279 interventional studies indexed under Dental Plaque.

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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.

Who can participate

Ages eligible: 18 Years to 65 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

Medical condition which requires pre-medication prior to dental visits/procedures
Advanced periodontal disease
5 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)

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Crossover assignment
Masking: Single (Participant)
Enrollment: 19 participants (actual)

Study arms

Placebo comparator
A - Marketed fluoride toothpaste
Drug: Sodium Monofluorophosphate
Active comparator
B -Triclosan/NaF/CoPolymer toothpaste
Drug: Triclosan/Fluoride/Copolymer

Interventions

DrugSodium Monofluorophosphate
Brush teeth and evaluate plaque score after one use of the study toothpaste
Also known as: Colgate Great Regular Flavor toothpaste
DrugTriclosan/Fluoride/Copolymer
Brush teeth and evaluate plaque score after one use of the study toothpaste
Also known as: Colgate Total toothpaste

What researchers measure

Primary outcomes

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.
Time frame: 1 day

Results

Posted Nov 25, 2008

Participant flow

At clinical site

First Intervention (1 Day)

Participant flow — First Intervention (1 Day)
Milestone	Fluoride 1st, Triclosan +Fluoride 2nd	Triclosan + Fluoride 1st, Fluoride 2nd
Started	10	9
Completed	8	8
Not completed	2	1
Withdrew: Physician decision	1	0
Withdrew: Withdrawal by subject	0	1
Withdrew: Screening failure	1	0

Washout After 1st Intervention (1 Week)

Participant flow — Washout After 1st Intervention (1 Week)
Milestone	Fluoride 1st, Triclosan +Fluoride 2nd	Triclosan + Fluoride 1st, Fluoride 2nd
Started	8	8
Completed	8	8
Not completed	0	0

Second Intervention (1 Day)

Participant flow — Second Intervention (1 Day)
Milestone	Fluoride 1st, Triclosan +Fluoride 2nd	Triclosan + Fluoride 1st, Fluoride 2nd
Started	8	8
Completed	8	8
Not completed	0	0

Outcome measures

PrimaryGingival 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.

Time frame:: 1 day
Reported as:: Mean · Units on a scale

Gingival Margin Plaque Index
Units on a scale	Fluoride	Triclosan + Fluoride
Gingival Margin Plaque Index	15.4 ± 14.74	12.81 ± 14.06

Statistical analysis

Fluoride vs Triclosan + Fluoride · ANOVA · p = 0.05

Adverse events

Collected over 3 weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Fluoride	—	0/18 (0%)	0/18 (0%)
Triclosan + Fluoride	—	0/17 (0%)	0/17 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Fluoride 1st, Then Triclosan +Fluoride 2nd	Triclosan + Fluoride 1st, Then Fluoride 2nd	Total
<=18 years	0	0	0
Between 18 and 65 years	10	9	19
>=65 years	0	0	0

Age Continuous
Age Continuous(years)	Fluoride 1st, Then Triclosan +Fluoride 2nd	Triclosan + Fluoride 1st, Then Fluoride 2nd	Total
Mean	32.1 ± 11.14	33 ± 8.7	32.53 ± 9.78

Sex: Female, Male
Sex: Female, Male(Participants)	Fluoride 1st, Then Triclosan +Fluoride 2nd	Triclosan + Fluoride 1st, Then Fluoride 2nd	Total
Female	8	8	16
Male	2	1	3

Region of Enrollment
Region of Enrollment(participants)	Fluoride 1st, Then Triclosan +Fluoride 2nd	Triclosan + Fluoride 1st, Then Fluoride 2nd	Total
United States	10	9	19

Study locations

1 site

Boston University School of Dental Medicine
New York, New York 10016, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 13, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00759031
Lead sponsor: Colgate Palmolive
Responsible party: Sponsor
First posted: Sep 25, 2008
Start date: Feb 2008
Primary completion: Mar 2008
Completion: Mar 2008
Results posted: Nov 25, 2008
Last update: Apr 13, 2012

Study contacts

Patricia Corby, DDS

principal investigator

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2012. You cannot join it, but the record below documents what was studied.

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