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NCT07842991From ClinicalTrials.govRecruiting

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

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

  • Plaque
  • Dental Plaque
  • Gingivitis

At a glance

Phase
Phase 3
Study type
Interventional
Sponsor
Colgate Palmolive
Enrolment target
120
Started
20 July 2026
Main results due
January 2027
Study sites
1
Registry updated
25 September 2026

Can you take part?

  • Ages 18 years to 70 years.
  • Open to any sex.
  • Healthy volunteers can take part.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(1)

  • Clinica Odontoiatrica Montesani

    Roma, Rome, Italy

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07842991. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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