Investigation of Clinical Efficacy of a New Mouthwash on Reducing Dental Plaque and Helping Prevent Gum Problems as Compared to a Control Mouthwash

Colgate-Palmolive

Status and phase: Active, not recruiting; Phase 3

Conditions: Plaque, Dental; Gingivitis

Treatments: Drug: sodium fluoride Mouthwash; Drug: cetylpyridinium chloride (CPC), zinc lactate and sodium fluoride Mouthwash

Study type: Interventional

Funder types: Industry

Identifiers

NCT07263698

CRO-2025-10-PGN-PRG-ITA-YPZ

Details and patient eligibility

About

Qualified subjects will be enrolled and randomized to either one of the two study groups described above based on their initial modified gingivitis and plaque scores. Subjects will be instructed to use the products according to the instructions provided. Subjects will return to the dental office for evaluation after two weeks, six weeks and three months of product use. All subjects will be followed for adverse events throughout the study

Enrollment: 80 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subjects, ages 18-70, inclusive.
• Availability for the three-month duration of the clinical research study.
• Good general health.
• Initial modified gingivitis index of at least 1.5 as determined by the use of the Modified Gingival Index.
• Initial plaque index of at least 1.5 as determined by the use of the Quigley-Hein Plaque Index.
• Signed Informed Consent Form (Appendix C)

Exclusion criteria

• Presence of orthodontic bands.
• 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 period 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups

Test 1 mouthwash

Experimental group

Description:

After brushing in the morning and in the evening, 20 ml of mouthwash shall be used for each rinsing, 2 times daily (morning and evening) for 30 seconds each time. No further rinsing with water shall be occurred after each mouthwash rising. Each qualified subject will follow this specific application for 3 months

Treatment:

Drug: cetylpyridinium chloride (CPC), zinc lactate and sodium fluoride Mouthwash

Test 2 mouthwash

Active Comparator group

Description:

After brushing either in the morning or in the evening, 20 ml of the mouthwash shall be used for each rinsing, 2 times daily (morning and evening) for 30 seconds each time

Treatment:

Drug: sodium fluoride Mouthwash