A Phase 3 interventional study of Toothpaste containing chitosan and Colgate Cavity Protection Toothpaste in Plaque, Dental and Gingivitis, sponsored by Colgate Palmolive. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-04-13.
Sponsored by Colgate Palmolive · Phase 3, Interventional, and Treatment
To assess the efficacy of a toothpaste containing chitosan in reducing plaque, gingivitis, and gingival bleeding, compared with Colgate Cavity Protection Toothpaste
352 studies on the registry are indexed under Dental Plaque; 60 are open to participants now.
This study's planned enrollment of 90 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.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
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.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Daily toothbrushing, Twice daily, 2 minutes each time
Drug: Toothpaste containing chitosan
Daily toothbrushing, Twice daily, 2 minutes each time
Drug: Colgate Cavity Protection Toothpaste
Toothpaste containing chitosan and a commercially available soft-bristled toothbrush
Fluoride Toothpaste and a commercially available soft-bristled toothbrush
Modified Gingival Index (MGI_ Lobene)
Clinical assessments will be carried out using the Modified Gingival Index (MGI; Lobene et al., 1986).MGI scoring criteria: 0: Absence of inflammation 1. Mild inflammation; slight change in color, little change in texture of any portion of, but not the entire, marginal or papillary gingival unit 2. Mild inflammation; as above, but involving the entire marginal or papillary gingival unit 3. Moderate inflammation; glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingival unit 4. Severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration
Time frame: Baseline, 2 week, 1 month & 3 month
Modified Plaque Index (MPI_ Turesky)
Using a red disclosing solution, a Modified Plaque Index (Turesky et al, 1970) score of 0-5 will be assigned to all scorable disclosed surfaces of the maxillary and mandibular teeth using a dental light and dental mirror. A whole-mouth score will be determined by summing the values for all scorable surfaces and dividing by the total number of surfaces scored. Modified Plaque Index (Turesky) scoring criteria: 0: No plaque 1. Separate flecks of plaque at the cervical margin 2. A thin, continuous band of plaque (up to 1 mm) at the cervical margin 3. A band of plaque wider than 1 mm but covering less than one-third of the crown 4. Plaque covering at least one-third but less than two-thirds of the crown 5. Plaque covering two-thirds or more of the crown
Time frame: Baseline, 2 week, 1 month & 3 month
Gingival Bleeding Index (GBI_ Saxton)
The examiner will conduct the Gingival Bleeding Index (GBI) examinations using the Saxton and van der Ouderaa methodology and a CPITN periodontal probe (0.5 mm ball end). Findings and GBI score calculations (including bleeding severity) will be recorded on the Gingival Bleeding Index Examination Form.
Time frame: Baseline, 2 week, 1 month & 3 month
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Apr 2026; primary completion for Jul 2026, 3 months later.
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 3 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.