Comparative Efficacy of Floss and Essential Oil/CPC+Zn Mouthwashes in Reducing Dental Plaque and Gingivitis

Colgate-Palmolive

Status and phase: Completed; Phase 4

Conditions: Dental Plaque; Gingivitis

Treatments: Device: Toothbrush; Device: Floss; Drug: Mouthwash; Drug: Toothpaste

Study type: Interventional

Funder types: Industry

Identifiers

NCT07029438

CRO-2025-FlossRinse-PG-GJ

Details and patient eligibility

About

The objective of this clinical research study is to evaluate the efficacy of floss to an essential oil alcohol-containing mouthwash, an essential oil alcohol-free mouthwash, and a CPC+Zn alcohol-free mouthwash in reducing dental plaque and gingivitis.

Enrollment: 228 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Male or female volunteers at least 18 years of age and in general good health.
• Willing and able to understand and sign the informed consent form.
• Whole mouth mean MGI ≥1.95, whole mouth mean TPI≥1.95, and ≥10% bleeding sites
• Be willing to conform to the study protocol and procedures.
• No sites with probing depth >4 mm.
• Minimum of 20 natural teeth with scorable facial and lingual surfaces

Exclusion criteria

• Medical condition which requires premedication prior to dental visits/procedure.
• Known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the study examiner.
• Active disease of the hard oral tissues.
• Significant oral soft tissue pathology, excluding plaque-induced gingivitis.
• Moderate to severe periodontitis (stages II-IV) per the EFP S3 guidelines.
• Subjects with fixed or removable orthodontic appliances or removable partial dentures.
• Dental prophylaxis within 30 days prior to study start.
• Use of antibiotics, antimicrobial drugs, anti-inflammatory drugs, or anticoagulant therapies within 30 days prior to study start.
• Use of chemotherapeutic oral care products within two weeks prior to study start.
• Participation in any other clinical study within 30 days prior to enrollment into this study.
• Subjects who must receive dental treatment during the study dates.
• Immunocompromised individuals (HIV, AIDS, immunosuppressive drug therapy).
• Use of smokeless tobacco, vaping, or e-cigarettes or suspected substance abuse.
• Current smokers (if former smoker, should have stopped at least 1 month prior to Visit 1)
• Pregnant or lactating subjects, or subjects planning to become pregnant during the course of the study.
• Medical condition which prohibits not eating/drinking or chewing gum for four (4) hours prior to your scheduled visits;
• Subjects who have an infectious disease and/or other blood borne diseases (Hepatitis series, HIV, tuberculosis).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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228 participants in 5 patient groups, including a placebo group

Brushing

Placebo Comparator group

Description:

Subjects will brush their teeth in their usual manner for 1 timed minute twice daily with the toothbrush and toothpaste provided. They will apply the toothpaste on the full length of the toothbrush. This arm will be the negative control arm (placebo comparator).

Treatment:

Drug: Toothpaste

Device: Toothbrush

Brushing and Flossing

Experimental group

Description:

Subjects will brush their teeth in their usual manner for 1 timed minute twice daily with the toothbrush and toothpaste provided. They will apply the toothpaste on the full length of the toothbrush. Subjects will floss their teeth after their first brushing instance of the day per instructed method from the study site.

Treatment:

Drug: Toothpaste

Device: Floss

Device: Toothbrush

Brushing and Rinsing A

Experimental group

Description:

Subjects will brush their teeth in their usual manner for 1 timed minute twice daily with the toothbrush and toothpaste provided. They will apply the toothpaste on the full length of the toothbrush. After both brushing instances, subjects will rinse full strength with 20 mL of Mouthwash A for 30 timed seconds.

Treatment:

Drug: Toothpaste

Drug: Mouthwash

Device: Toothbrush

Brushing and Rinsing B

Experimental group

Description:

Subjects will brush their teeth in their usual manner for 1 timed minute twice daily with the toothbrush and toothpaste provided. They will apply the toothpaste on the full length of the toothbrush. After both brushing instances, subjects will rinse full strength with 20 mL of Mouthwash B for 30 timed seconds.

Treatment:

Drug: Toothpaste

Drug: Mouthwash

Device: Toothbrush

Brushing and Rinsing C

Experimental group

Description:

Subjects will brush their teeth in their usual manner for 1 timed minute twice daily with the toothbrush and toothpaste provided. They will apply the toothpaste on the full length of the toothbrush. After both brushing instances, subjects will rinse full strength with 20 mL of Mouthwash C for 30 timed seconds.

Treatment:

Drug: Toothpaste

Drug: Mouthwash

Device: Toothbrush