Study to Determine the Anti-plaque Efficacy of Commerical Toothpastes and an Oral Rinse
Primary Purpose
Dental Plaque
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Fluoride
Triclosan, fluoride
Chlorhexidine Gluconate
Sponsored by
About this trial
This is an interventional treatment trial for Dental Plaque
Eligibility Criteria
Inclusion Criteria:
- Be aged 18 to 65 years inclusive
- Have a minimum of 15 natural uncrowned teeth (excluding 3rd molars) present
- Give written informed consent
- Be in good general health
- 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
- If of childbearing potential and on birth control (Diaphragm, Birth Control Pills, Birth Control Implants, IUD (Intrauterine device), condoms)
Exclusion Criteria:
- Medical condition which requires pre-medication (antibiotics) prior to dental
- Visits/procedures
- Allergy to chlorhexidine
- Advanced periodontal disease (gum disease)
- 5 or more decayed, untreated dental sites (cavities)
- Diseases of the soft or hard oral tissues (gums or palate)
- Orthodontic appliances that interfere with plaque rating
- Abnormal salivary function
- Use of drugs that can affect currently salivary flow or production
- 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 research study in the month preceding this study
- Allergic to common toothpaste or mouth rinse ingredients.
- Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy) or individuals who have a high risk of infection from other causes
Sites / Locations
- TKL Research, Inc.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Active Comparator
Active Comparator
Arm Label
Fluoride toothpaste
Triclosan/Fluoride toothpaste
Chlorhexidine Oral Rinse
Arm Description
negative control toothpaste
positive control toothpaste (Total toothpaste)
positive control oral rinse
Outcomes
Primary Outcome Measures
Plaque Index
Plaque score is 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)
Secondary Outcome Measures
Full Information
NCT ID
NCT01024738
First Posted
September 26, 2008
Last Updated
November 27, 2009
Sponsor
Colgate Palmolive
1. Study Identification
Unique Protocol Identification Number
NCT01024738
Brief Title
Study to Determine the Anti-plaque Efficacy of Commerical Toothpastes and an Oral Rinse
Official Title
Study to Determine the Anti-plaque Efficacy of Commerical Toothpastes and an Oral Rinse
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
March 2008 (undefined)
Primary Completion Date
April 2008 (Actual)
Study Completion Date
April 2008 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Colgate Palmolive
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Calibration study to determine the anit-plaque efficacy of commerical toothpastes and an oral rinse
Detailed Description
Training of new examiners and validation of new clinical site to run 4 day short-term plaque studies. All products are commercially available.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Plaque
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
22 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fluoride toothpaste
Arm Type
Placebo Comparator
Arm Description
negative control toothpaste
Arm Title
Triclosan/Fluoride toothpaste
Arm Type
Active Comparator
Arm Description
positive control toothpaste (Total toothpaste)
Arm Title
Chlorhexidine Oral Rinse
Arm Type
Active Comparator
Arm Description
positive control oral rinse
Intervention Type
Drug
Intervention Name(s)
Fluoride
Intervention Description
Brush half mouth twice daily for four days.
Intervention Type
Drug
Intervention Name(s)
Triclosan, fluoride
Other Intervention Name(s)
Total toothpaste
Intervention Description
Brush twice daily
Intervention Type
Drug
Intervention Name(s)
Chlorhexidine Gluconate
Intervention Description
Rinse mouth twice a day
Primary Outcome Measure Information:
Title
Plaque Index
Description
Plaque score is 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)
Time Frame
4 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Be aged 18 to 65 years inclusive
Have a minimum of 15 natural uncrowned teeth (excluding 3rd molars) present
Give written informed consent
Be in good general health
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
If of childbearing potential and on birth control (Diaphragm, Birth Control Pills, Birth Control Implants, IUD (Intrauterine device), condoms)
Exclusion Criteria:
Medical condition which requires pre-medication (antibiotics) prior to dental
Visits/procedures
Allergy to chlorhexidine
Advanced periodontal disease (gum disease)
5 or more decayed, untreated dental sites (cavities)
Diseases of the soft or hard oral tissues (gums or palate)
Orthodontic appliances that interfere with plaque rating
Abnormal salivary function
Use of drugs that can affect currently salivary flow or production
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 research study in the month preceding this study
Allergic to common toothpaste or mouth rinse ingredients.
Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy) or individuals who have a high risk of infection from other causes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark LeFelt, DDS
Official's Role
Principal Investigator
Facility Information:
Facility Name
TKL Research, Inc.
City
Paramus
State/Province
New Jersey
ZIP/Postal Code
07652
Country
United States
12. IPD Sharing Statement
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Study to Determine the Anti-plaque Efficacy of Commerical Toothpastes and an Oral Rinse
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