Train New Examiners Via Modified Gingival Margin Plaque
This study has been completed.
Sponsor:
Colgate Palmolive
Information provided by:
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT00758563
First received: September 23, 2008
Last updated: November 20, 2008
Last verified: November 2008
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Purpose
The purpose of this study is to train new examiners while testing two commercial products using our standard one-day brushing study regimen by measuring gingival margin plaque index.
| Condition | Intervention | Phase |
|---|---|---|
|
Dental Plaque |
Drug: Fluoride Drug: Triclosan/Fluoride |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Train New Examiners Via Modified Gingival Margin Plaque |
Resource links provided by NLM:
Further study details as provided by Colgate Palmolive:
Primary Outcome Measures:
- Mean Gingival Plaque Units [ Time Frame: 1 day ] [ Designated as safety issue: No ]
| Enrollment: | 15 |
| Study Start Date: | March 2008 |
| Study Completion Date: | April 2008 |
| Primary Completion Date: | April 2008 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Placebo Comparator: A |
Drug: Fluoride
Brush twice daily
|
| Active Comparator: B |
Drug: Triclosan/Fluoride
Brush twice daily
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- Male or female volunteers 18-65 years of age
- Good general health
- Must sign informed consent form
- Must discontinue oral hygiene for 24-hrs.after initial appointment.
- Minimum of 20 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.
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 or heavy dental tartar (calculus).
- 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 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)
Contacts and Locations
More Information
No publications provided
| Responsible Party: | William DeVizio/VP - Clinical Research, Colgate Palmolive |
| ClinicalTrials.gov Identifier: | NCT00758563 History of Changes |
| Other Study ID Numbers: | CRO-0907-PLA-18-RR |
| Study First Received: | September 23, 2008 |
| Results First Received: | October 16, 2008 |
| Last Updated: | November 20, 2008 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Dental Plaque Dental Deposits Tooth Diseases Stomatognathic Diseases Fluorides Triclosan Cariostatic Agents Protective Agents Physiological Effects of Drugs |
Pharmacologic Actions Fatty Acid Synthesis Inhibitors Hypolipidemic Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Anti-Infective Agents, Local Anti-Infective Agents Therapeutic Uses Lipid Regulating Agents |
ClinicalTrials.gov processed this record on May 19, 2013