CompletedNCT00762515Updated Dec 28, 2010Results posted

Clinical Study to Evaluate the Treatment of Gingivitis of Two Toothpastes

A Phase 3 interventional study of Fluoride and Triclosan 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 2010-12-28.

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

Phase: Phase 3
Study type: Interventional
Enrollment: 44
Allocation: Randomized
Ages: 18 Years to 65 Years
Sex: All

Study summary

The objective is to compare two commerical oral products for the treatment of gingivitis.

Conditions studied

Dental Plaque

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Dental Plaque 322

In context

Dental Plaque

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

This study's enrollment of 44 is below the median of 59 across 286 interventional studies indexed under Dental Plaque.

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Lead sponsor

Colgate Palmolive is the lead sponsor of 118 studies on the registry; 13 are open to participants now.

Of its 35 completed or terminated interventional studies of FDA-regulated products, 2 (6%) have results posted.

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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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

Male or female volunteers 18-65 years of age
Good general health
Must sign informed consent form
Minimum of 16 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.
Dental Selection Criteria: Gingivitis patients with a minimum of 16 gradable teeth with a minimum of 6 sites with a GI score of ≥ 3. Subjects will be stratified according to gingivitis severity. Average full mouth GI score should be in the range of 2.0 - 2.5. heavy plaque formers should be avoided. Target a full mouth PI (Quigley-Hein) to be in the range of 1.5-3.0

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
History of allergy to iodine
History of thyroid disease
History of diabetes
2 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 flow.
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.
History of allergy to common dentifrice ingredients
Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)
Women of childbearing potential and not on birth control (Diaphragm, birth control pills or implants, IUD (Intrauterine device), condoms).
Smoker

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 44 participants (actual)

Study arms

Placebo comparator
A
commercially available Fluoride only toothpaste
Drug: Fluoride
Active comparator
B
Commercially available triclosan/copolymer/fluoride toothpaste
Drug: Triclosan · Drug: Fluoride

Interventions

DrugFluoride
Brush teeth two times daily for 6 weeks
DrugTriclosan
Brush two times daily for 6 weeks
DrugFluoride
Brush two times daily for 6 weeks

What researchers measure

Primary outcomes

Control Established Plaque in Adults
Units on a 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. Total Plaque score=sum of all scores divided by the number of sites (teeth) scored.
Time frame: 6 weeks

Secondary outcomes

Control Gingivitis in Adults
Gingivitis Index (GI) is described as Units on a scale 0 to 3 (0 = no inflammation,1 = Mild inflammation - slight change in color and little change in texture 2 = Moderate inflammation - moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding. GI score = Sum of all scores divided by the number of sites (teeth scored).
Time frame: 6 weeks

Results

Posted Dec 14, 2010

Participant flow

subjects recruited by the PI at the clinical site.

Participant flow — Overall Study
Milestone	A -Placebo Comparator	B- Active Comparator
Started	22	22
Completed	22	22
Not completed	0	0

Outcome measures

PrimaryControl Established Plaque in Adults

Units on a 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. Total Plaque score=sum of all scores divided by the number of sites (teeth) scored.

Time frame:: 6 weeks
Reported as:: Mean · Units on a scale

Control Established Plaque in Adults
Units on a scale	A -Placebo Comparator	B- Active Comparator
Control Established Plaque in Adults	2.42 ± 0.47	2.45 ± 0.53

Statistical analysis

A -Placebo Comparator vs B- Active Comparator · ANCOVA · p = <0.05baseline is used a factor

SecondaryControl Gingivitis in Adults

Gingivitis Index (GI) is described as Units on a scale 0 to 3 (0 = no inflammation,1 = Mild inflammation - slight change in color and little change in texture 2 = Moderate inflammation - moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding. GI score = Sum of all scores divided by the number of sites (teeth scored).

Time frame:: 6 weeks
Reported as:: Mean · Units on a scale

Control Gingivitis in Adults
Units on a scale	A -Placebo Comparator	B- Active Comparator
Control Gingivitis in Adults	0.54 ± 0.16	0.63 ± 0.19

Statistical analysis

A -Placebo Comparator vs B- Active Comparator · ANCOVA · p = <0.05baseline to be used a factor

Adverse events

Collected over 7 weeks. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
A -Placebo Comparator	—	0/22 (0%)	0/22 (0%)
B- Active Comparator	—	0/22 (0%)	0/22 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	A -Placebo Comparator	B- Active Comparator	Total
<=18 years	0	0	0
Between 18 and 65 years	22	22	44
>=65 years	0	0	0

Sex: Female, Male
Sex: Female, Male(Participants)	A -Placebo Comparator	B- Active Comparator	Total
Female	15	13	28
Male	7	9	16

Region of Enrollment
Region of Enrollment(participants)	A -Placebo Comparator	B- Active Comparator	Total
United States	22	22	44

Study locations

1 site

University of Louisville, School of Dentistry
Louisville, Kentucky 40292, United States

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Feb 2008, a primary completion of Aug 2008 and a completion of Aug 2008. It does not say whether these dates are actual or estimated.

Results were first posted in Dec 2010, 2 years 4 months after primary completion.

How these figures are worked out, and which studies are left out of them.

Registered: Sep 26, 2008
First posted: Sep 30, 2008
Start: Feb 2008
Primary completionActual: Aug 2008
CompletionActual: Aug 2008
Results first posted: Dec 14, 2010
Last update: Dec 28, 2010

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Dec 28, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT00762515
Lead sponsor: Colgate Palmolive
First posted: Sep 30, 2008
Start date: Feb 2008
Primary completion: Aug 2008
Completion: Aug 2008
Results posted: Dec 14, 2010
Last update: Dec 28, 2010

Study contacts

Denis Kinane, BDS

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 Dec 2010. You cannot join it, but the record below documents what was studied.

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