NCT07842991 Clinical Evaluation of a Toothpaste for Dental Plaque Reduction and Prevention of Gum Problems
| NCT ID | NCT07842991 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Colgate Palmolive |
| Condition | Plaque |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2026-07-20 |
| Primary Completion | 2027-01 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 120 participants in total. It began in 2026-07-20 with a primary completion date of 2027-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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
Contact & Investigator
Luigi Montensani, DDS
PRINCIPAL INVESTIGATOR
Clinica Odontoiatrica Montesani
Frequently Asked Questions
Who can join the NCT07842991 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Plaque. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07842991 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 120 participants.
Is NCT07842991 currently recruiting?
Yes, NCT07842991 is actively recruiting participants. Contact the research team at luigi@montensani.it for enrollment information.
Where is the NCT07842991 trial being conducted?
This trial is being conducted at Roma, Italy.
Who is sponsoring the NCT07842991 clinical trial?
NCT07842991 is sponsored by Colgate Palmolive. The principal investigator is Luigi Montensani, DDS at Clinica Odontoiatrica Montesani. The trial plans to enroll 120 participants.