Investigation of Dental Plaque and Gingival Index
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ClinicalTrials.gov Identifier: NCT00759031 |
Recruitment Status :
Completed
First Posted : September 25, 2008
Results First Posted : November 25, 2008
Last Update Posted : April 13, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Dental Plaque | Drug: Sodium Monofluorophosphate Drug: Triclosan/Fluoride/Copolymer | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 19 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Treatment |
Official Title: | Investigation of Dental Plaque and Gingival Index |
Study Start Date : | February 2008 |
Actual Primary Completion Date : | March 2008 |
Actual Study Completion Date : | March 2008 |

Arm | Intervention/treatment |
---|---|
Placebo Comparator: A - Marketed fluoride toothpaste |
Drug: Sodium Monofluorophosphate
Brush teeth and evaluate plaque score after one use of the study toothpaste
Other Name: Colgate Great Regular Flavor toothpaste |
Active Comparator: B -Triclosan/NaF/CoPolymer toothpaste |
Drug: Triclosan/Fluoride/Copolymer
Brush teeth and evaluate plaque score after one use of the study toothpaste
Other Name: Colgate Total toothpaste |
- Gingival Margin Plaque Index [ Time Frame: 1 day ]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.

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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:
- 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:
- 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)

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): NCT00759031
United States, New York | |
Boston University School of Dental Medicine | |
New York, New York, United States, 10016 |
Principal Investigator: | Patricia Corby, DDS |
Responsible Party: | Colgate Palmolive |
ClinicalTrials.gov Identifier: | NCT00759031 |
Other Study ID Numbers: |
CRO-2007-PLA-23-RR |
First Posted: | September 25, 2008 Key Record Dates |
Results First Posted: | November 25, 2008 |
Last Update Posted: | April 13, 2012 |
Last Verified: | April 2012 |
Dental Plaque Dental Deposits Tooth Diseases Stomatognathic Diseases Listerine Triclosan Fluorides Sodium Fluoride Fluorophosphate 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 |