Efficacy of Salivary Bacteria and Post Brushing
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ClinicalTrials.gov Identifier: NCT00981825 |
Recruitment Status :
Completed
First Posted : September 22, 2009
Results First Posted : September 22, 2009
Last Update Posted : June 14, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Salivary Bacteria Levels | Drug: Fluoride Drug: Triclosan/Fluoride | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 22 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Efficacy of Salivary Bacteria and Post Brushing |
Study Start Date : | October 2007 |
Actual Primary Completion Date : | December 2007 |
Actual Study Completion Date : | December 2007 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: A
fluoride toothpaste control
|
Drug: Fluoride
Whole mouth brushing for 7 days
Other Name: fluoride toothpaste (Colgate Great Regular Flavor toothpaste) |
Active Comparator: B
triclosan/fluoride toothpaste
|
Drug: Triclosan/Fluoride
Brush whole mouth twice daily for 7 days
Other Name: triclosan/fluoride toothpaste (Colgate Total toothpaste) |
- CFU (Colony Forming Units) [ Time Frame: 4 hours ]Total number of salivary bacterial colony forming units (lower number = less colonies present)

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Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Male or female volunteers 18-65 years of age
- Good general health
- Must sign informed consent form
- Must discontinue oral hygiene on the mornings of each appointment and between sampling periods.
- 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:
- Medical condition which requires pre-medication prior to dental procedures/visits
- Medical condition which precludes eating/drinking for 12 hrs.
- History of allergy to common dentifrice ingredients
- Subjects unable or unwilling to sign the informed consent form.
- Moderate or advanced periodontal disease.
- 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 can currently affect salivary flow
- Current use of antibiotics
- 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 30 days 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.
- Immune compromised individuals (HIV,AIDS, immuno suppressive drug therapy)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00981825
India | |
India GTC, Colgate Palmolive(I) ltd | |
Mumbai, India |
Principal Investigator: | Neelim Utgikar, DDS |
Responsible Party: | William DeVizio/VP - Clinical Research, Colgate Palmolive |
ClinicalTrials.gov Identifier: | NCT00981825 |
Other Study ID Numbers: |
ER0-2007-SAL-01-GX |
First Posted: | September 22, 2009 Key Record Dates |
Results First Posted: | September 22, 2009 |
Last Update Posted: | June 14, 2011 |
Last Verified: | June 2011 |
Listerine Triclosan Fluorides Sodium Fluoride Cariostatic Agents Protective Agents Physiological Effects of Drugs |
Anti-Infective Agents, Local Anti-Infective Agents Fatty Acid Synthesis Inhibitors Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Lipid Regulating Agents |