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Trial record 3 of 43 for:    FLUORIDE ION AND TRICLOSAN

Clinical Study Comparing Dental Plaque and Gingivitis Reduction After Using One of Three Oral Hygiene Multi-component Regimens (Using of a Manual Toothbrush, a Toothpaste and a Mouthwash)

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ClinicalTrials.gov Identifier: NCT02366689
Recruitment Status : Completed
First Posted : February 19, 2015
Results First Posted : March 30, 2016
Last Update Posted : March 30, 2016
Sponsor:
Information provided by (Responsible Party):
Colgate Palmolive

Brief Summary:
The objective of this clinical research study is to assess the efficacy of a commercially available triclosan/copolymer toothpaste compared to a commercially available oral hygiene multi-component regimen encompassing the use of a manual toothbrush, a toothpaste containing stannous fluoride / sodium hexametaphosphate and a mouthwash containing cetylpyridinium chloride relative to a negative control regimen in reducing established dental plaque and gingivitis over three and six months of assigned product use.

Condition or disease Intervention/treatment Phase
Dental Plaque Gingivitis Drug: Triclosan/fluoride toothpaste Drug: stannous fluoride toothpaste Drug: fluoride only toothpaste Drug: Cetylpyridinium chloride mouthwash Drug: Fluoride only mouthwash Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 179 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Efficacy in Reducing Established Dental Plaque and Gingivitis of a Toothpaste Containing 0.3% Triclosan, 2% Copolymer / Sodium Fluoride and a Manual Toothbrush as Compared to an Oral Hygiene Multi-component Regimen Encompassing the Use of a Manual Toothbrush, a Toothpaste Containing Stannous Fluoride / Sodium Hexametaphosphate and a Mouthwash Containing 0.07% Cetylpyridinium Chloride
Study Start Date : June 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Arm Intervention/treatment
Active Comparator: Toothpaste
Triclosan/fluoride toothpaste
Drug: Triclosan/fluoride toothpaste
Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration).
Other Name: Total toothpaste

Active Comparator: Toothpaste + mouthwash
stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash
Drug: stannous fluoride toothpaste
Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration).
Other Name: Crest Pro-Health toothpaste

Drug: Cetylpyridinium chloride mouthwash
Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds.
Other Name: Crest Pro-Health Multi-Protection Mouthwash

Placebo Comparator: Fluoride only Toothpaste + mouthwash
Fluoride only toothpaste + Fluoride only Mouthwash
Drug: fluoride only toothpaste
Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds.
Other Name: Crest Cavity Protection toothpaste

Drug: Fluoride only mouthwash
Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds.
Other Name: Crest Pro-Health For Me Breezy Mint mouthwash




Primary Outcome Measures :
  1. Dental Plaque Scores [ Time Frame: Baseline ]
    Dental Plaque (Quigley-Hein, Turesky Modification Index) 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)

  2. Dental Plaque Scores [ Time Frame: 3 months ]
    Dental Plaque (Quigley-Hein, Turesky Modification Index) 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)

  3. Dental Plaque Scores [ Time Frame: 6 months ]
    Dental Plaque (Quigley-Hein, Turesky Modification Index) 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)

  4. Gingivitis Scores [ Time Frame: Baseline ]
    Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)

  5. Gingivitis Scores [ Time Frame: 3 months ]
    Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)

  6. Gingivitis Scores [ Time Frame: 6 months ]
    Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male and female subjects, ages 18-70, inclusive.
  2. Availability for the six-month duration of the study.
  3. Good general health.
  4. Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
  5. Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
  6. Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
  7. Signed Informed Consent Form.

Exclusion Criteria:

  1. Presence of orthodontic bands.
  2. Presence of partial removable dentures.
  3. Tumor(s) of the soft or hard tissues of the oral cavity.
  4. Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
  5. Five or more carious lesions requiring immediate restorative treatment.
  6. Use of antibiotics any time during the one month prior to entry into the study.
  7. Participation in any other clinical study or test panel within the one month prior to entry into the study.
  8. Pregnant women or women who are breast feeding.
  9. Dental prophylaxis received in the past two weeks prior to baseline examinations.
  10. History of allergies to oral care/personal care consumer products or their ingredients.
  11. On any prescription medicines that might interfere with the study outcome.
  12. An existing medical condition which prohibits eating or drinking for periods up to 4 hours.
  13. History of alcohol or drug abuse

Information from the National Library of Medicine

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): NCT02366689


Locations
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United States, New Jersey
Concordia Clinical Research
Cedar Knolls, New Jersey, United States, 07927
Sponsors and Collaborators
Colgate Palmolive

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Responsible Party: Colgate Palmolive
ClinicalTrials.gov Identifier: NCT02366689     History of Changes
Other Study ID Numbers: CRO-2014-05-PG-6MCTCPG-ED
First Posted: February 19, 2015    Key Record Dates
Results First Posted: March 30, 2016
Last Update Posted: March 30, 2016
Last Verified: February 2015
Additional relevant MeSH terms:
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Triclosan
Fluorides
Tin Fluorides
Sodium Fluoride
Gingivitis
Dental Plaque
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Dental Deposits
Tooth Diseases
Cetylpyridinium
Listerine
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