ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02193165
Recruitment Status : Completed
First Posted : July 17, 2014
Results First Posted : February 6, 2015
Last Update Posted : August 17, 2015
Sponsor:
Information provided by (Responsible Party):
Colgate Palmolive

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Dental Plaque Gingivitis Drug: triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash Drug: stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash Drug: fluoride toothpaste + fluoride Mouthwash Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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 Start Date : July 2014
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dental Health

Arm Intervention/treatment
Active Comparator: Regimen 1
triclosan/fluoride toothpaste + cetylpyridinium chloride Mouthwash
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.
Other Names:
  • Total toothpaste
  • Total Mouthwash

Active Comparator: Regimen 2
stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash
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.
Other Names:
  • Crest Pro-Health toothpaste
  • Crest Pro-Health Multi-Protection Mouthwash

Placebo Comparator: Regimen 3 - Control group
fluoride toothpaste + fluoride Mouthwash
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.
Other Names:
  • Crest Cavity Protection toothpaste
  • 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: 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)

  3. 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)

  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: 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)

  6. 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)



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   21 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 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

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): NCT02193165


Locations
Puerto Rico
Centro Comercial Plaza Trujillo
Trujillo Alto, Puerto Rico, 00976
Sponsors and Collaborators
Colgate Palmolive

Responsible Party: Colgate Palmolive
ClinicalTrials.gov Identifier: NCT02193165     History of Changes
Other Study ID Numbers: CRO-2014-07-PG-REG-PR-BS
First Posted: July 17, 2014    Key Record Dates
Results First Posted: February 6, 2015
Last Update Posted: August 17, 2015
Last Verified: July 2015

Additional relevant MeSH terms:
Gingivitis
Dental Plaque
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Dental Deposits
Tooth Diseases
Fluorides
Tin Fluorides
Sodium Fluoride
Triclosan
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