The Clinical Efficacy of Three Oral Hygiene Regimens Using a Manual Toothbrush, Toothpaste and a Mouthwash in Controlling Dental Plaque and Gingivitis

Overview

The objective of this clinical research study is to assess the efficacy of three oral hygiene multi-component regimens encompassing the use of a manual toothbrush, toothpaste and a mouthwash in controlling established dental plaque and gingivitis.

Full Title of Study: “The Comparative Efficacy of Three Oral Hygiene Multi-component Regimens Encompassing the Use of a Manual Toothbrush, Toothpaste and a Mouthwash in Controlling Established Dental Plaque and Gingivitis.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: August 2014

Interventions

  • Drug: triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash
    • Brush whole mouth with Total toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using a Total 360 toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of mouthwash for 30 seconds.
  • Drug: stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash
    • Brush whole mouth with Crest Pro-Health toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Pro-Health toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health Multi-Protection mouthwash for 30 seconds.
  • Drug: fluoride toothpaste + fluoride Mouthwash
    • Brush whole mouth with Crest Cavity Protection toothpaste for 1 minute, 2 times/day for 6 weeks (study duration) using an Oral B Indicator toothbrush. Immediately after each toothbrushing, rinse whole mouth with 20 ml of Crest Pro-Health For Me Breezy Mint mouthwash for 30 seconds.

Arms, Groups and Cohorts

  • Active Comparator: Regimen 1
    • triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash
  • Active Comparator: Regimen 2
    • stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash
  • Placebo Comparator: Regimen 3 – Control group
    • fluoride toothpaste + fluoride Mouthwash

Clinical Trial Outcome Measures

Primary Measures

  • 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)
  • Dental Plaque Scores
    • Time Frame: 4 weeks
    • 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)
  • Dental Plaque Scores
    • Time Frame: 6 weeks
    • 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)
  • 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)
  • Gingivitis Scores
    • Time Frame: 4 weeks
    • 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)
  • Gingivitis Scores
    • Time Frame: 6 weeks
    • 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)

Participating in This Clinical Trial

Inclusion Criteria

1. Male and female subjects, ages 21-70, inclusive. 2. Availability for the six-week 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

Gender Eligibility: All

Minimum Age: 21 Years

Maximum Age: 70 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Colgate Palmolive
  • Provider of Information About this Clinical Study
    • Sponsor

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