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Completed

NCT Number: NCT07029438

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

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.

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Key information

Conditions

Dental Plaque Dental Deposits Gingival Diseases Gingivitis Infections Mouth Diseases Periodontal Diseases Stomatognathic Diseases Tooth Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Salus Research, Inc.

Fort Wayne, Indiana, 46825, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Mouthwash

Drug

Antiplaque/Antigingivitis Mouthwash

Floss

Device

Dental Floss

Toothbrush

Device

Soft bristled, manual toothbrush

Toothpaste

Drug

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

Primary outcomes

  1. Interproximal mean Modified Gingival Index (MGI)

    Time frame: 12 weeks

    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

    • = mild inflammation; slight changes in color and texture, but not in all portions of gingival marginal or papillary
    • = mild inflammation; slight changes in color and texture in all portions of gingival margin or papillary
    • = moderate inflammation; bright surface inflammation, erythema, edema, and/or hypertrophy of gingival marginal or papillary
    • = severe inflammation; erythema, edema, and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion, or ulceration

Secondary outcomes

  1. Whole Mouth mean Modified Gingival Index (MGI)

    Time frame: 1, 4, and 12 weeks

    MGI will be visually assessed for six sites for each graded tooth (mesiofacial, facial, distofacial, mesiolingual, lingual, distolingual). Whole Mouth MGI includes all six sites. Higher scores indicate a worse outcome, per below.

    0 = no inflammation; no redness

    • = mild inflammation; slight changes in color and texture, but not in all portions of gingival marginal or papillary
    • = mild inflammation; slight changes in color and texture in all portions of gingival margin or papillary
    • = moderate inflammation; bright surface inflammation, erythema, edema, and/or hypertrophy of gingival marginal or papillary
    • = severe inflammation; erythema, edema, and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion, or ulceration

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

    Time frame: 1, 4, and 12 weeks

    Dental plaque will be assessed at six sites for each graded tooth (mesiofacial, facial, distofacial, mesiolingual, lingual, distolingual) and scored as follows:

    0=No plaque

    • Separate flecks of plaque at the cervical margin
    • A thin, continuous band of plaque (up to 1 mm) at the cervical margin
    • A band of plaque wider than 1 mm, but covering less than 1/3 of the side of the crown of the tooth
    • Plaque covering at least 1/3, but less than 2/3 of the side of the crown of the tooth
    • Plaque covering 2/3 or more of the side of the crown of the tooth

    Interproximal mean includes mesiofacial, distofacial, mesiolingual, and distolingual sites. Higher scores indicate a worse outcome, per above.

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

    Time frame: 1, 4, and 12 weeks

    Dental plaque will be assessed at six sites for each graded tooth (mesiofacial, facial, distofacial, mesiolingual, lingual, distolingual) and scored as follows:

    0=No plaque

    • Separate flecks of plaque at the cervical margin
    • A thin, continuous band of plaque (up to 1 mm) at the cervical margin
    • A band of plaque wider than 1 mm, but covering less than 1/3 of the side of the crown of the tooth
    • Plaque covering at least 1/3, but less than 2/3 of the side of the crown of the tooth
    • Plaque covering 2/3 or more of the side of the crown of the tooth

    Whole Mouth mean includes all six sites. Higher scores indicate a worse outcome, per above.

  4. Interproximal mean Expanded Bleeding Index (EBI)

    Time frame: 1, 4, and 12 weeks

    EBI will be assessed at six sites for each graded tooth (mesiofacial, facial, distofacial, mesiolingual, lingual, distolingual) by engaging a probe 1 mm into the gingival crevice and applying moderate pressure whilst sweeping from interproximal to interproximal along the sulcular epithelium. Interproximal mean includes mesiofacial, distofacial, mesiolingual, and distolingual sites. A higher score indicates a worse outcome, per below.

    0 = no bleeding after 30 seconds

    • = bleeding upon probing after 30 seconds
    • = immediate bleeding observed

  5. Whole Mouth Expanded Bleeding Index (EBI)

    Time frame: 1, 4, and 12 weeks

    EBI will be assessed at six sites for each graded tooth (mesiofacial, facial, distofacial, mesiolingual, lingual, distolingual) by engaging a probe 1 mm into the gingival crevice and applying moderate pressure whilst sweeping from interproximal to interproximal along the sulcular epithelium. Whole Mouth mean includes all six sites. A higher score indicates a worse outcome, per below.

    0 = no bleeding after 30 seconds

    • = bleeding upon probing after 30 seconds
    • = immediate bleeding observed

  6. Interproximal mean Bleeding on Probing (BOP)

    Time frame: 12 weeks

    Bleeding on probing will be assessed at six sites for each graded tooth (mesiofacial, facial, distofacial, mesiolingual, lingual, distolingual) and scored as 1 = yes bleeding, 0 = no bleeding. Interproximal mean includes mesiofacial, distofacial, mesiolingual, and distolingual sites. A higher score indicates a worse outcome.

  7. Whole Mouth mean Bleeding on Probing (BOP)

    Time frame: 12 weeks

    Bleeding on probing will be assessed at six sites for each graded tooth (mesiofacial, facial, distofacial, mesiolingual, lingual, distolingual) and scored as 1 = yes bleeding, 0 = no bleeding. Whole Mouth mean includes all six sites. A higher score indicates a worse outcome.

  8. Interproximal mean Probing Depth (PD)

    Time frame: 12 weeks

    Probing depth will be measured at six sites for each graded tooth (mesiofacial, facial, distofacial, mesiolingual, lingual, distolingual) using a calibrated periodontal probe to ensure precision and consistency. Interproximal mean includes mesiofacial, distofacial, mesiolingual, and distolingual sites.

    Measurements will be recorded to the nearest millimeter, with particular attention to maintaining gentle and consistent pressure to avoid measurement variability. Larger measurements indicate a worse condition.

  9. Whole Mouth mean Probing Depth (PD)

    Time frame: 12 weeks

    Probing depth will be measured at six sites for each graded tooth (mesiofacial, facial, distofacial, mesiolingual, lingual, distolingual) using a calibrated periodontal probe to ensure precision and consistency. Interproximal mean includes mesiofacial, distofacial, mesiolingual, and distolingual sites.

    Measurements will be recorded to the nearest millimeter, with particular attention to maintaining gentle and consistent pressure to avoid measurement variability. Larger measurements indicate a worse condition.

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Official study title

Clinical Study to Evaluate the Comparative Efficacy of Floss, Essential Oil Mouthwashes, and an Alcohol-free CPC+Zn Mouthwash in Reducing Dental Plaque and Gingivitis

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jun 19, 2025
Registry last updated
Oct 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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