Investigation of Dental Plaque and Gingival Index
This study has been completed.
Sponsor:
Colgate Palmolive
Information provided by (Responsible Party):
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT00759031
First received: September 23, 2008
Last updated: April 11, 2012
Last verified: April 2012
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Purpose
Investigation of inhibitory effect of prototype toothpaste on dental plaque formation via modified gingival margin plaque index method.
| Condition | Intervention | Phase |
|---|---|---|
|
Dental Plaque |
Drug: Sodium Monofluorophosphate Drug: Triclosan/Fluoride/Copolymer |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Crossover Assignment Masking: Single Blind (Participant) Primary Purpose: Treatment |
| Official Title: | Investigation of Dental Plaque and Gingival Index |
Resource links provided by NLM:
Further study details as provided by Colgate Palmolive:
Primary Outcome Measures:
- 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.
| Enrollment: | 19 |
| Study Start Date: | February 2008 |
| Study Completion Date: | March 2008 |
| Primary Completion Date: | March 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
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)
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00759031
Please refer to this study by its ClinicalTrials.gov identifier: NCT00759031
Locations
| United States, New York | |
| Boston University School of Dental Medicine | |
| New York, New York, United States, 10016 | |
Sponsors and Collaborators
Colgate Palmolive
Investigators
| Principal Investigator: | Patricia Corby, DDS |
More Information
| Responsible Party: | Colgate Palmolive |
| ClinicalTrials.gov Identifier: | NCT00759031 History of Changes |
| Other Study ID Numbers: |
CRO-2007-PLA-23-RR |
| Study First Received: | September 23, 2008 |
| Results First Received: | October 16, 2008 |
| Last Updated: | April 11, 2012 |
Additional relevant MeSH terms:
|
Dental Plaque Dental Deposits Tooth Diseases Stomatognathic Diseases Fluorophosphate Sodium Fluoride Fluorides Listerine Triclosan 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 |
ClinicalTrials.gov processed this record on May 25, 2017