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

NCT ID: NCT07029438

Last Updated: 2025-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 228 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-07-07
• Study Completion Date: 2025-10-16

Brief Summary

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.

Conditions

Dental Plaque; Gingivitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Brushing

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).

Group Type: PLACEBO_COMPARATOR

Toothbrush

Intervention Type: DEVICE

Soft bristled, manual toothbrush

Toothpaste

Intervention Type: DRUG

Sodium Monofluorophosphate 0.76 % (0.15% w/v fluoride ion) toothpaste

Brushing and Flossing

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.

Group Type: EXPERIMENTAL

Floss

Intervention Type: DEVICE

Dental Floss

Toothbrush

Intervention Type: DEVICE

Soft bristled, manual toothbrush

Toothpaste

Intervention Type: DRUG

Sodium Monofluorophosphate 0.76 % (0.15% w/v fluoride ion) toothpaste

Brushing and Rinsing A

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.

Group Type: EXPERIMENTAL

Mouthwash

Intervention Type: DRUG

Antiplaque/Antigingivitis Mouthwash

Toothbrush

Intervention Type: DEVICE

Soft bristled, manual toothbrush

Toothpaste

Intervention Type: DRUG

Sodium Monofluorophosphate 0.76 % (0.15% w/v fluoride ion) toothpaste

Brushing and Rinsing B

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.

Group Type: EXPERIMENTAL

Mouthwash

Intervention Type: DRUG

Antiplaque/Antigingivitis Mouthwash

Toothbrush

Intervention Type: DEVICE

Soft bristled, manual toothbrush

Toothpaste

Intervention Type: DRUG

Sodium Monofluorophosphate 0.76 % (0.15% w/v fluoride ion) toothpaste

Brushing and Rinsing C

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.

Group Type: EXPERIMENTAL

Mouthwash

Intervention Type: DRUG

Antiplaque/Antigingivitis Mouthwash

Toothbrush

Intervention Type: DEVICE

Soft bristled, manual toothbrush

Toothpaste

Intervention Type: DRUG

Sodium Monofluorophosphate 0.76 % (0.15% w/v fluoride ion) toothpaste

Interventions

Mouthwash

Antiplaque/Antigingivitis Mouthwash

Intervention Type: DRUG

Floss

Dental Floss

Intervention Type: DEVICE

Toothbrush

Soft bristled, manual toothbrush

Intervention Type: DEVICE

Toothpaste

Sodium Monofluorophosphate 0.76 % (0.15% w/v fluoride ion) toothpaste

Intervention Type: DRUG

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Colgate Palmolive

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jeffery Milleman, DDS, MPA

Role: PRINCIPAL_INVESTIGATOR

Salus Research, Inc.

Locations

Salus Research, Inc.

Fort Wayne, Indiana, United States

Countries

United States

Other Identifiers

CRO-2025-FlossRinse-PG-GJ

Identifier Type: -

Identifier Source: org_study_id