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NCT Number: NCT07842991

Clinical Evaluation of a Toothpaste for Dental Plaque Reduction and Prevention of Gum Problems

Qualified subjects will be enrolled and randomized to either one of the three 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 three months and six months of product use. All subjects will be followed for adverse events throughout the study.

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Key information

Conditions

Plaque Dental Deposits Dental Plaque Gingival Diseases Gingivitis Infections Mouth Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Periodontal Diseases Plaque, Amyloid 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

Location status: Recruiting

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 six-month duration of the study.
  • Good general health.
  • Initial gingivitis index of at least 1.5 as determined by the use of the Modified Gingivitis Index.
  • Initial plaque index of at least 1.5 as determined by the use of the Modified Quigley-Hein Plaque Index.
  • Signed Informed Consent Form

Exclusion criteria

  • 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
  • Use of antibiotics any time during the one month 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.
  • Received a dental prophylaxis in the two weeks prior to your initial examination.
  • History of allergies to oral care/personal care consumer products or their ingredients.
  • Having taken any prescription medicines that might interfere with the study outcome.
  • If you with an existing medical condition which prohibits you from not eating or drinking for periods of up to 4 hours.
  • Self-reported pregnant or breast feeding an infant.
  • History of drug abuse

Treatment and study plan

0.45% SnF HW with NaF (1450 F)

Drug

toothpaste

67% Bicarbonate with NaF (1400 F)

Drug

toothpaste

Colgate Cavity Protection Toothpaste

Drug

Toothpaste with MFP/NaF (1450 F)

Primary outcomes

  1. Lobene Modified Gingivitis Assessment

    Time frame: Baseline, 3 month, 6 month

    Modified Gingivitis Index score from 0 to 4 will be assigned by the examining dentist to all tooth surfaces using a dental light and dental mirror. A whole mouth mean score for each subject will be determined by adding the values given by the examining dentist to each scoreable surface and dividing that number by the total number of surfaces scored

  2. Saxton Gingival Bleeding Assessment

    Time frame: Baseline, 3 month, 6 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, 3 month, 6 month

    First using a red dye solution to disclose the plaque, a Modified Quigley-Hein Plaque Index score of 0 to 5 will be assigned to all scoreable disclosed tooth surfaces using a dental light and dental mirror. A whole mouth score for each subject will be determined by adding the values given by the dental examiner to each scoreable surface and dividing that number by the total number of surfaces scored.

Interested in participating?

Recruiting

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Official study title

Clinical Evaluation of a Stannous Fluoride Toothpaste Versus a 67% Bicarbonate Toothpaste and Colgate Cavity Protection Toothpaste for Dental Plaque Reduction and Prevention of Gum Problems: a Six-month Clinical Study in Italy

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Sep 25, 2026
Registry last updated
Sep 25, 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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