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

NCT07029438 | Completed Phase 4 FDA Drug

• 1 other identifier: CRO-2025-FlossRinse-PG-GJ
• Study Type: interventional
• Target: 228
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Interproximal mean Modified Gingival Index (MGI)

  MGI will be visually assessed for six sites for each graded tooth (mesiofacial, facial, distofacial, mesiolingual, lingual, distolingual). Interproximal MGI includes the mesiofacial, distofacial, mesiolingual, and distolingual sites. Higher scores indicate a worse outcome, per below. 0 = no inflammation; no redness 1. = mild inflammation; slight changes in color and texture, but not in all portions of gingival marginal or papillary 2. = mild inflammation; slight changes in color and texture in all portions of gingival margin or papillary 3. = moderate inflammation; bright surface inflammation, erythema, edema, and/or hypertrophy of gingival marginal or papillary 4. = severe inflammation; erythema, edema, and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion, or ulceration

  12 weeks

Secondary Outcomes (9)

• Whole Mouth mean Modified Gingival Index (MGI)

  1, 4, and 12 weeks

• Interproximal mean Turesky Modification of the Quigley-Hein Plaque Index (TPI)

  1, 4, and 12 weeks

• Whole Mouth mean Turesky Modification of the Quigley-Hein Plaque Index (TPI)

  1, 4, and 12 weeks

• Interproximal mean Expanded Bleeding Index (EBI)

  1, 4, and 12 weeks

• Whole Mouth Expanded Bleeding Index (EBI)

  1, 4, and 12 weeks

Study Arms (5)

Brushing

PLACEBO COMPARATOR

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).

Device: Toothbrush; Drug: Toothpaste

Brushing and Flossing

EXPERIMENTAL

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.

Device: Floss; Device: Toothbrush; Drug: Toothpaste

Brushing and Rinsing A

EXPERIMENTAL

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.

Drug: Mouthwash; Device: Toothbrush; Drug: Toothpaste

Brushing and Rinsing B

EXPERIMENTAL

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.

Drug: Mouthwash; Device: Toothbrush; Drug: Toothpaste

Brushing and Rinsing C

EXPERIMENTAL

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.

Drug: Mouthwash; Device: Toothbrush; Drug: Toothpaste

Interventions

Mouthwash DRUG

Antiplaque/Antigingivitis Mouthwash

Brushing and Rinsing A; Brushing and Rinsing B; Brushing and Rinsing C

Floss DEVICE

Dental Floss

Brushing and Flossing

Toothbrush DEVICE

Soft bristled, manual toothbrush

Brushing; Brushing and Flossing; Brushing and Rinsing A; Brushing and Rinsing B; Brushing and Rinsing C

Toothpaste DRUG

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

Brushing; Brushing and Flossing; Brushing and Rinsing A; Brushing and Rinsing B; Brushing and Rinsing C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

Salus Research, Inc.

Fort Wayne, Indiana, 46825, United States

Location

MeSH Terms

Conditions

Dental Plaque; Gingivitis

Interventions

Mouthwashes; Dental Devices, Home Care; Toothpastes

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Infections; Gingival Diseases; Periodontal Diseases; Mouth Diseases

Intervention Hierarchy (Ancestors)

Biomedical and Dental Materials; Specialty Uses of Chemicals; Chemical Actions and Uses; Cosmetics; Manufactured Materials; Technology, Industry, and Agriculture; Dental Equipment; Dentistry; Oral Hygiene; Preventive Dentistry; Equipment and Supplies; Dentifrices

Study Officials

• Jeffery Milleman, DDS, MPA

  Salus Research, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 29, 2025
• First Posted: June 19, 2025
• Study Start: July 7, 2025
• Primary Completion: October 16, 2025
• Study Completion: October 16, 2025
• Last Updated: October 30, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: ICF, CSR

Locations

US (1)