Toothpaste for reducing dental plaque and preventing gum problems

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

In this Phase 3 interventional trial, eligible adults aged 18-70 with baseline gingivitis and plaque scores are randomized to three toothpaste regimens and instructed to use them as directed. Participants will be evaluated at 3 and 6 months for changes in gingivitis and plaque and monitored for adverse events. The trial is conducted at a single site in Rome with Colgate-Palmolive as the lead sponsor. Safety and effectiveness data will inform whether the products can reduce gum inflammation and plaque formation compared with standard care. Enrollment requires informed consent and compliance with study visits over six months.

Why it matters

Who can join: the full rules

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

Where it's running

• Clinica Odontoiatrica Montesani
  Roma, Rome, Italy Recruiting

Study contacts

• Principal investigator: Luigi Montensani, DDS — Clinica Odontoiatrica Montesani
• Study coordinator: Luigi Montensani, DDS
• Email: luigi@montensani.it
• Phone: +39-338-6187383;

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Effect of stannous fluoride toothpaste on gingival health indicators in an experimental gingivitis model

  This study tests whether a toothpaste with stannous fluoride can influence gingival crevicular fluid biomarkers and help gingival tissue recover during early gingivitis.

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• Toothpaste that may reduce plaque and gingivitis in Chinese adults

  A toothpaste test will be used to see if it reduces plaque and gingivitis more than a regular fluoride toothpaste in Chinese people with localized gingivitis.

  Recruiting Haleon · Shanghai, Shanghai Municipality · NCT07816406

• Safety and effectiveness of an electric flosser with a manual toothbrush for gingivitis and plaque

  This study tests whether using an electric interproximal flosser in addition to a manual toothbrush can reduce gingival inflammation and plaque in adults with gingivitis compared with brushing alone.

  Recruiting Flaus, Inc · Fort Wayne, Indiana · NCT07779564

• Dental plaque and gum health study using fluoride toothpaste in adults with varying gingivitis and plaque levels

  This study tests a fluoride toothpaste to see how it affects dental plaque and gingivitis in adults with high plaque, including groups with low and high gingival inflammation.

  Recruiting Phase 4 Colgate Palmolive · Fort Wayne, Indiana · NCT07614490

• Pure green tea mouthwash versus placebo and essential-oil rinses for plaque and gum inflammation

  This trial will see if rinsing twice daily with a pure green tea mouthwash reduces dental plaque and gum inflammation in healthy adults compared with placebo and two commercial mouthwashes.

  Recruiting King Abdullah University Hospital · Irbid, Irbid Governorate · NCT07364565

• Coenzyme Q10 toothpaste with daily Limosilactobacillus reuteri probiotics to improve gum health during pregnancy

  For pregnant women with gum disease, this will try whether adding a CoQ10 toothpaste and daily L. reuteri probiotic to regular cleanings reduces plaque and gum bleeding.

  Recruiting University of Pavia · Pavia, Lombardy · NCT07029360

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.