A Phase 3 interventional study of 0.45% SnF HW with NaF (1450 F) and 67% Bicarbonate with NaF (1400 F) in Plaque, Dental Plaque and Gingivitis, sponsored by Colgate Palmolive. Recruiting at 1 site in Italy. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-25.
Sponsored by Colgate Palmolive · Phase 3, Interventional, and Prevention
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.
352 studies on the registry are indexed under Dental Plaque; 60 are open to participants now.
This study's planned enrollment of 120 is above the median of 56 across 316 interventional studies indexed under Dental Plaque.
Browse Dental Plaque studies →Colgate Palmolive is the lead sponsor of 119 studies on the registry; 13 are open to participants now.
Of its 36 completed or terminated interventional studies of FDA-regulated products, 2 (6%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Approximately, 1.5 grams (full ribbon covering the head of toothbrush) of toothpaste shall be used for each brushing, 2 times daily (morning and evening) for 2 minutes each time
Drug: 0.45% SnF HW with NaF (1450 F)
Approximately, 1.5 grams (full ribbon covering the head of toothbrush) of toothpaste shall be used for each brushing, 2 times daily (morning and evening) for 2 minutes each time
Drug: 67% Bicarbonate with NaF (1400 F)
Approximately, 1.5 grams (full ribbon covering the head of toothbrush) of toothpaste shall be used for each brushing, 2 times daily (morning and evening) for 2 minutes each time
Drug: Colgate Cavity Protection Toothpaste
toothpaste
Drug pages: Bicarbonates · Sodium Fluoride
toothpaste
Toothpaste with MFP/NaF (1450 F)
Lobene Modified Gingivitis Assessment
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
Time frame: Baseline, 3 month, 6 month
Saxton Gingival Bleeding Assessment
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
Time frame: Baseline, 3 month, 6 month
Modified Quigley-Hein Plaque Index
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.
Time frame: Baseline, 3 month, 6 month
Plan to share: No
No publications or documents are linked to this record.
Started Jul 2026 (actual). Primary completion is estimated for Jan 2027, 6 months after the start.
Of 20 phase 3 interventional studies under Dental Plaque, half reached primary completion within 2 months of starting (the median), counting those still running; a quarter within 1 and three quarters within 4. This study's planned 6 months is above that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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