Bleeding GumNCT06955871
Clinical Investigation of Bleeding Reduction Efficacy on Toothpaste Containing 1.05% Chitosan
A study testing Toothpaste containing 1.05% Chitosan, Silica-based NaF Toothpaste and Toothpaste with 67% bicarbonate in people with Bleeding Gum and Gingivitis, run by Colgate Palmolive at 1 site in China.
Trial summary
The purpose of this study is to assess the bleeding reduction efficacy of toothpaste containing 1.05% Chitosan compared to a regular fluoride toothpaste, and compared to a toothpaste containing 67% bicarbonate. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bleeding Gum, Gingivitis
- What is being tested?
- Toothpaste containing 1.05% Chitosan, Silica-based NaF Toothpaste and Toothpaste with 67% bicarbonate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 134 participants
- Where
- 1 siteChina
- Study dates
- 29 Apr 2025to 4 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects, aged 18-70, inclusive.
- Availability for the duration of the study.
- Ability to understand and willingness to read, and sign the Informed Consent Form after the nature of the study has been fully explained to them.
- Willingness 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 constitute a risk to the subject while participating in the study. Examples include heart problems, valve/hip replacements etc).
- Presence of a minimum of 20 natural teeth (excluding third molars) with facial and lingual scoreable surfaces.
- Have a mean Modified Gingival Index (Lobene) ≥ 2.5 at screening.
- Subjects reporting bleeding while routine toothbrushing.
Who cannot join
- Pregnant or lactating.
- Use of tobacco products.
- History of alcohol or drug abuse.
- Medical condition (especially, heart or liver problems, bleeding disorders, blood dyscrasias) or any current usage of medication that the investigator considers may compromise the subject safety, as well as, the quality of the study results.
- Medical condition which requires pre-medication prior to dental visits/procedures.
- History of allergy to oral hygiene products.
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- Use of anti-inflammatory, immunosuppressive, antimicrobial or anticoagulant drugs or antibiotics in the 30 days prior to the start of the study and during the course of the study.
- Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine).
- Presence of orthodontic bands or removable partial denture(s).
- Tumor (s) of the soft or hard tissues of the oral cavity.
- Five or more carious lesions requiring immediate restorative treatment.
- More than 2 periodontal pockets (>4mm deep) with bleeding on probing.
- Any gingival condition like hyperplasia or overgrowth, that would cause difficulty in clinical assessment.
- Participation in any other clinical study with an oral care indication or test panel within 30 days prior to the start of the study.
- Existing medical condition which prohibits the subject from not eating or drinking for periods of up to 2 hours.
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to assess the bleeding reduction efficacy of toothpaste containing 1.05% Chitosan compared to a regular fluoride toothpaste, and compared to a toothpaste containing 67% bicarbonate.
- Conditions
- Bleeding Gum, Gingivitis
- Being tested
- Toothpaste containing 1.05% Chitosan, Silica-based NaF Toothpaste, Toothpaste with 67% bicarbonate
- Medical subject headings
- Gingival Hemorrhage, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Toothpaste containing 1.05% ChitosanOther
Toothpaste containing 1.05% Chitosan
Silica-based NaF ToothpasteOther
Silica-based NaF Toothpaste
Toothpaste with 67% bicarbonateOther
Toothpaste containing 67% Bicarbonate
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Toothpaste containing 1.05% Chitosan, soft-bristled toothbrush Receives: Other: Toothpaste containing 1.05% Chitosan |
| Positive control | Active comparator | Toothpaste containing 67% Bicarbonate, soft-bristled toothbrush Receives: Other: Toothpaste with 67% bicarbonate |
| Negative control | Placebo comparator | Silica-based NaF Toothpaste, soft-bristled toothbrush Receives: Other: Silica-based NaF Toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival Bleeding
Gingival Bleeding Index described by Saxton and van der Ouderaa (1989).
Measured: From baseline to 3 days, 7 days and 14 days after baseline.
Gingivitis
Modified Gingival Index (MGI) Lobene et al (1986)
Measured: Baseline, and immediately post-brushing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2025
- Study start29 Apr 2025
- Primary completion4 Jun 2025
- Study completion4 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bleeding GumStudies of the same condition, open and under way.
- More trials run by Colgate PalmoliveThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06955871
- Sponsor's protocol ID
- CRO-2024-11-BLD-CHT-MS
- Status last verified
- Aug 2025
- First submitted
- 25 Apr 2025
- Last updated
- 15 Aug 2025
- 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 15 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Investigation of Bleeding Reduction Efficacy on Toothpaste Containing 1.05% Chitosan
- ClinicalTrials.gov ID
- NCT06955871
- Acronym / sponsor ID
- CRO-2024-11-BLD-CHT-MS
- Conditions
- Bleeding Gum, Gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- 29 Apr 2025 (actual)
- Primary completion
- 4 Jun 2025 (actual)
- Study completion
- 4 Jun 2025 (actual)
- First posted
- 2 May 2025 (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.
The purpose of this study is to assess the bleeding reduction efficacy of toothpaste containing 1.05% Chitosan compared to a regular fluoride toothpaste, and compared to a toothpaste containing 67% bicarbonate.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Other: Toothpaste containing 1.05% ChitosanToothpaste containing 1.05% Chitosan, soft-bristled toothbrush |
| Positive control | Active comparator | Other: Toothpaste with 67% bicarbonateToothpaste containing 67% Bicarbonate, soft-bristled toothbrush |
| Negative control | Placebo comparator | Other: Silica-based NaF ToothpasteSilica-based NaF Toothpaste, soft-bristled toothbrush |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female subjects, aged 18-70, inclusive.
- Availability for the duration of the study.
- Ability to understand and willingness to read, and sign the Informed Consent Form after the nature of the study has been fully explained to them.
- Willingness 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 constitute a risk to the subject while participating in the study. Examples include heart problems, valve/hip replacements etc).
Key exclusion criteria (15 listed)
- Pregnant or lactating.
- Use of tobacco products.
- History of alcohol or drug abuse.
- Medical condition (especially, heart or liver problems, bleeding disorders, blood dyscrasias) or any current usage of medication that the investigator considers may compromise the subject safety, as well as, the quality of the study results.
- Medical condition which requires 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 1.05% ChitosanToothpaste containing 1.05% Chitosan | Other | Test |
| Silica-based NaF ToothpasteSilica-based NaF Toothpaste | Other | Negative control |
| Toothpaste with 67% bicarbonateToothpaste containing 67% Bicarbonate | Other | Positive control |
Primary outcome
Gingival Bleeding
Time frame: From baseline to 3 days, 7 days and 14 days after baseline.
Gingival Bleeding Index described by Saxton and van der Ouderaa (1989).
Gingivitis
Time frame: Baseline, and immediately post-brushing
Modified Gingival Index (MGI) Lobene et al (1986)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2025.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Toothpaste containing 1.05% Chitosan, Silica-based NaF Toothpaste and Toothpaste with 67% bicarbonate in people with Bleeding Gum 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: finished, as of the sponsor's last update on 15 Aug 2025. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival Bleeding (time frame: From baseline to 3 days, 7 days and 14 days after baseline.). The study lists 2 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 15 Aug 2025.