Plaque, DentalPhase 3NCT07499115
Efficacy of a Toothpaste in Reducing Plaque, Gingivitis, and Gingival Bleeding
A Phase 3 study testing Toothpaste containing chitosan and Colgate Cavity Protection Toothpaste in people with Plaque, Dental and Gingivitis, run by Colgate Palmolive at 1 site in China.
Trial summary
To assess the efficacy of a toothpaste containing chitosan in reducing plaque, gingivitis, and gingival bleeding, compared with Colgate Cavity Protection Toothpaste Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Plaque, Dental, Gingivitis
- What is being tested?
- Toothpaste containing chitosan and Colgate Cavity Protection Toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Apr 2026to Jul 2026
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female, aged 18-70 years (inclusive).
- Available for the duration of the study.
- Able to understand and willing to read and sign the Informed Consent Form after the nature of the study has been fully explained.
- Willing to comply with all study procedures and clinical examination schedules.
- Good general health (absence of any condition that, in the opinion of the study examiner, might pose risk during participation; e.g., certain heart conditions, valve/hip replacements).
- Presence of at least 20 natural teeth (excluding third molars) with scorable facial and lingual surfaces.
- Mean Modified Gingival Index (MGI, Lobene) ≥ 2.0 and Mean Modified Plaque Index (MPI, Turesky) ≥ 1.5 at screening.
- Willing and able to complete study questionnaires on product usage experience during routine toothbrushing.
Who cannot join
- Pregnant or lactating.
- Use of tobacco products.
- History of alcohol or drug abuse.
- Any medical condition (e.g., significant heart or liver disease, bleeding disorders, blood dyscrasias) or current medication use that, in the investigator's judgment, may compromise subject safety or the quality of study results.
- Medical condition requiring pre-medication prior to dental visits/procedures.
- History of allergy to oral hygiene products.
Show all 15Show fewer
- Use of anti-inflammatory, immunosuppressive, antimicrobial, or anticoagulant drugs, or antibiotics within 30 days prior to study start or during the study.
- Ongoing use of medications known to affect gingival tissues (e.g., calcium channel blockers, phenytoin, cyclosporine).
- Presence of orthodontic bands or removable partial dentures.
- Tumors of the soft or hard tissues of the oral cavity.
- Five or more carious lesions requiring immediate restorative treatment.
- More than two periodontal pockets (>4 mm) with bleeding on probing.
- Any gingival condition (e.g., hyperplasia or overgrowth) that would interfere with clinical assessment.
- Participation in another clinical study with an oral care indication or test panel within 30 days prior to study start.
- Medical condition that prohibits abstaining from eating or drinking for up to 2 hours.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Clinical Investigation of the Efficacy of a Toothpaste Containing Chitosan in Reducing Plaque, Gingivitis, and Gingival Bleeding
To assess the efficacy of a toothpaste containing chitosan in reducing plaque, gingivitis, and gingival bleeding, compared with Colgate Cavity Protection Toothpaste
- Conditions
- Plaque, Dental, Gingivitis
- Being tested
- Toothpaste containing chitosan, Colgate Cavity Protection Toothpaste
- Medical subject headings
- Dental Plaque, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toothpaste containing chitosanDrug
Toothpaste containing chitosan and a commercially available soft-bristled toothbrush
Colgate Cavity Protection ToothpasteDrug
Fluoride Toothpaste and a commercially available soft-bristled toothbrush
| Study group | Role | What they receive |
|---|---|---|
| Test Toothpaste | Experimental | Daily toothbrushing, Twice daily, 2 minutes each time Receives: Drug: Toothpaste containing chitosan |
| Control Toothpaste | Active comparator | Daily toothbrushing, Twice daily, 2 minutes each time Receives: Drug: Colgate Cavity Protection Toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- Mild inflammation; slight change in color, little change in texture of any portion of, but not the entire, marginal or papillary gingival unit
- Mild inflammation; as above, but involving the entire marginal or papillary gingival unit
- Moderate inflammation; glazing, redness, edema, and/or hypertrophy of the marginal or papillary gingival unit
- Severe inflammation; marked redness, edema and/or hypertrophy of the marginal or papillary gingival unit, spontaneous bleeding, congestion, or ulceration
Measured: 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
- Separate flecks of plaque at the cervical margin
- A thin, continuous band of plaque (up to 1 mm) at the cervical margin
- A band of plaque wider than 1 mm but covering less than one-third of the crown
- Plaque covering at least one-third but less than two-thirds of the crown
- Plaque covering two-thirds or more of the crown
Measured: 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.
Measured: Baseline, 2 week, 1 month & 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study startApr 2026 (estimated)
- Primary completionJul 2026 (estimated)
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque, DentalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Deyu Hu, Principal investigator, West China Dental Institute of Chengdu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07499115
- Sponsor's protocol ID
- CRO-2025-10-PGB-CHT-YPZ
- Status last verified
- Mar 2026
- First submitted
- 24 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of the Efficacy of a Toothpaste Containing Chitosan in Reducing Plaque, Gingivitis, and Gingival Bleeding
- ClinicalTrials.gov ID
- NCT07499115
- Acronym / sponsor ID
- CRO-2025-10-PGB-CHT-YPZ
- Conditions
- Plaque, Dental, Gingivitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- Apr 2026 (estimated)
- Primary completion
- Jul 2026 (estimated)
- Study completion
- Jul 2026 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the efficacy of a toothpaste containing chitosan in reducing plaque, gingivitis, and gingival bleeding, compared with Colgate Cavity Protection Toothpaste
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Toothpaste | Experimental | Drug: Toothpaste containing chitosanDaily toothbrushing, Twice daily, 2 minutes each time |
| Control Toothpaste | Active comparator | Drug: Colgate Cavity Protection ToothpasteDaily toothbrushing, Twice daily, 2 minutes each time |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female, aged 18-70 years (inclusive).
- Available for the duration of the study.
- Able to understand and willing to read and sign the Informed Consent Form after the nature of the study has been fully explained.
- Willing to comply with all study procedures and clinical examination schedules.
- Good general health (absence of any condition that, in the opinion of the study examiner, might pose risk during participation; e.g., certain heart conditions, valve/hip replacements).
Key exclusion criteria (15 listed)
- Pregnant or lactating.
- Use of tobacco products.
- History of alcohol or drug abuse.
- Any medical condition (e.g., significant heart or liver disease, bleeding disorders, blood dyscrasias) or current medication use that, in the investigator's judgment, may compromise subject safety or the quality of study results.
- Medical condition requiring pre-medication prior to dental visits/procedures.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Toothpaste containing chitosanToothpaste containing chitosan and a commercially available soft-bristled toothbrush | Drug | Test Toothpaste |
| Colgate Cavity Protection ToothpasteFluoride Toothpaste and a commercially available soft-bristled toothbrush | Drug | Control Toothpaste |
Primary outcome
Modified Gingival Index (MGI_ Lobene)
Time frame: Baseline, 2 week, 1 month & 3 month
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
Modified Plaque Index (MPI_ Turesky)
Time frame: Baseline, 2 week, 1 month & 3 month
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
Gingival Bleeding Index (GBI_ Saxton)
Time frame: Baseline, 2 week, 1 month & 3 month
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: No
Related trials for Plaque, Dental
Not yet recruiting
Effect of Xylitol- Versus Erythritol-Sweetened Mints on Plaque ATP-Bioluminescence Readings
Dental Caries, Dental Plaque
Not yet recruitingObservational study
Plaque and Bleeding on Probing Around Implants Supporting Fixed Full-Arch Dental Prostheses
Peri-Implant Health
Not yet recruiting
Effectiveness of Oil Pulling Using Oils in Comparison With Mouthwash for Gingivitis
Gingivitis
Not yet recruiting
Individualized Management of Plaque-Related Gingival Inflammation in Routine Dental Practice
Plaque-Induced Gingivitis
Recruiting
The Study to Evaluate the Plaque Control and Anti-Gingivitis Efficacy of a Toothpaste in Chinese Population
Dental Plaque, Gingivitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Deyu Hu principal investigator
West China Dental Institute of Chengdu
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Toothpaste containing chitosan and Colgate Cavity Protection Toothpaste in people with Plaque, Dental and Gingivitis, run by Colgate Palmolive at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Deyu Hu, DDS (1390-803-4990, hudeyu@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Modified Gingival Index (MGI_ Lobene) (time frame: Baseline, 2 week, 1 month & 3 month). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.