The Clinical Investigation of Toothpaste as Compared to Toothpaste and Mouthwash in Reducing Plaque and Gingivitis: A Six-week Clinical Study in the US

Completed · Phase 4

Conditions studied: Dental Plaque, Gingivitis

In brief

The objective of this clinical research study is to evaluate clinical efficacy of Colgate Total Toothpaste as compared to Crest Pro-Health Toothpaste and Crest Pro-Health Mouthwash, and Crest Cavity Protection Toothpaste and Crest Fluoride Mouthwash in reducing gingivitis and dental plaque in adults in a six-week clinical study.

Key facts

Study ID

NCT02360995

Run by

Colgate Palmolive

People needed

129

Starts

2014-06-01

Expected to finish

2014-08-01

Last updated by the study team

2016-03-30

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Subjects, ages 18-70, inclusive.
• Availability for the six-week duration of the clinical research study.
• Good general health.
• Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
• Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
• Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
• Signed Informed Consent Form

You may not qualify if…

• Presence of orthodontic bands.
• Presence of partial removable dentures.
• Tumor(s) of the soft or hard tissues of the oral cavity.
• Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
• Five or more carious lesions requiring immediate restorative treatment.
• Antibiotic use any time during the one month prior to entry into the study.
• Participation in any other clinical study or test panel within the one month prior to entry into the study.
• Dental prophylaxis during the past two weeks prior to baseline examinations.
• History of allergies to oral care/personal care consumer products or their ingredients.
• On any prescription medicines that might interfere with the study outcome.
• An existing medical condition which prohibits eating or drinking for periods up to 4 hours.
• History of alcohol or drug abuse.
• Pregnant or lactating subjects.

Where it is running

• Loma Linda University — Loma Linda, California, United States

Full record on ClinicalTrials.gov

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