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Completed

NCT Number: NCT07263698

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

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

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Key information

Conditions

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

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinica Odontoiatrica Montesani

Roma, Rome, 00187, Italy

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

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

Drug

0.09% CPC, 0.28% zinc lactate and 500 ppm F as sodium fluoride

sodium fluoride Mouthwash

Drug

100 ppm F as sodium fluoride

Primary outcomes

  1. Modified Gingival Index

    Time frame: baseline, 2 week, 6 week & 3 month

    A Modified Gingivitis Index score from 0 to 4 will be assigned by the examiner to all tooth surfaces. In regards to the scale, lower number is a better outcome.

  2. Saxton Bleeding Index

    Time frame: baseline, 2 week, 6 week & 3 month

    Gingival bleeding is assessed 30 seconds after probing; a score of 0 represents an absence of bleeding.

    a score of 1 is given if bleeding is observed within 30 seconds after probing and a score of 2 is given if bleeding is observed immediately on probing

  3. Modified Quigley-Hein Plaque Index

    Time frame: baseline, 2 week, 6 week & 3 month

    Modified Quigley-Hein Plaque Index score of 0 to 5 will be assigned to all scoreable disclosed tooth surfaces. In regards to the scale, lower number is a better outcome.

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Official study title

Investigation of Clinical Efficacy of a New Mouthwash on Reducing Dental Plaque and Helping Prevent Gum Problems as Compared to a Control Mouthwash - a Three-month Study in Italy

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Dec 4, 2025
Registry last updated
May 26, 2026

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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