GingivitisPhase 3CHX TPNCT06732466
Evaluation of the Effect of a Toothpaste Containing 0.3% Chlorhexidine in Subjects With Established Dental Plaque and Gingivitis
A Phase 3 study testing Chlorhexidine toothpaste and Toothbrush in people with Gingivitis and Gingivitis and Periodontal Diseases, run by Colgate Palmolive at 1 site in Brazil.
Trial summary
This is a Phase III, one-center, parallel group, double blind, clinical study to evaluate the effect of a toothpaste containing 0.3% chlorhexidine in subjects with established dental plaque and gingivitis. It involves 80 participants aged between 18 and 70, randomly assigned to different groups, and spans 21 days. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gingivitis, Gingivitis and Periodontal Diseases, Gingival Disease
- What is being tested?
- Chlorhexidine toothpaste and Toothbrush
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteBrazil
- Study dates
- 24 Mar 2025to 15 Apr 2025
- Phase
- Phase 3
- 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
- Males and females, between 18-70 years of age;
- Availability for the duration of the study;
- Good general health (absence of any condition that, in the opinion of the Principal Investigator, might constitute a risk to the subject while participating in the study. Examples include heart problems, valve/hip replacements, etc);
- Willingness to provide information related to their medical history;
- Minimum of 20 uncrowned permanent natural teeth (excluding third molars and crowns);
- Initial gingivitis index a minimum average score of 1.5 as determined by the use of the Löe and Silness Gingival Index;
- More than 30% of bleeding sites and absence of periodontal disease;
- Informed Consent Form signed.
Who cannot join
- Absence of visible clinical signs of periodontal disease, such as the presence of suppuration, dental mobility, and/or extensive attachment loss;
- That received dental prophylaxis within 1 month prior to the Baseline visit;
- Oral pathology or a history of allergy to testing products;
- Subject using anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory medication or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study; to be defined by the dental examiner;
- Subject participating in any other clinical study;
- Subject pregnant or breastfeeding;
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- Subject allergic to oral care products, personal care consumer products, or their ingredients;
- Extended use of antibiotics or therapeutic mouthwash (eg: Chlorhexidine) any time during the three months prior to entry into the study;
- Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine);
- Current smokers and subjects with a history of alcohol or drug abuse;
- Subjects with orthodontic appliances or presence of fixed or removable prosthodontics dentures that may interfere with the evaluations
- An existing medical condition (eg: diabetic people) which prohibits eating or drinking for periods up to 4 hours.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul
About this study
Official title: Clinical Research Study to Evaluate the Effect of a Toothpaste Containing Chlorhexidine 0.3% in Subjects With Established Dental Plaque and Gingivitis
This is a Phase III, one-center, parallel group, double blind, clinical study to evaluate the effect of a toothpaste containing 0.3% chlorhexidine in subjects with established dental plaque and gingivitis. It involves 80 participants aged between 18 and 70, randomly assigned to different groups, and spans 21 days.
Read the detailed description
This clinical study aims to evaluate the effect of a toothpaste containing 0.3% chlorhexidine in subjects with established dental plaque and gingivitis. It is a Phase III study designed as randomized, one-center, double blind, parallel group trial involving 80 participants aged 18 to 70. Subjects will be divided into two groups: test group - subjects assigned to use a toothpaste with a 0.3% chlorhexidine + 3% AmCl and brush with a commercially available adult soft bristle toothbrush; negative control group - subjects assigned to use a placebo toothpaste without chlorhexidine and AmCl and brush with a commercially available adult soft bristle toothbrush. Subjects will undergo baseline, 14 days and 21 days evaluations. The primary outcome will be reduction of gingival inflammation and data will be analyzed using ANCOVA to assess the efficacy of the test product. Adverse events and compliance will be closely monitored, with strict confidentiality maintained for all participants. The study rigorous design aims to provide comprehensive insights into the effectiveness of the chlorhexidine toothpaste regarding gingivitis and dental plaque control.
- Being tested
- Chlorhexidine toothpaste, Toothbrush, Placebo toothpaste without chlorhexidine and AmCl
- Keywords
- chlorhexidine, toothpastes, gingivitis, dental plaque
- Medical subject headings
- Gingivitis, Periodontal Diseases, Gingival Diseases, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chlorhexidine toothpasteDrug
A toothpaste containing 0.3% chlorhexidine + 3% AmCl
ToothbrushDevice
Commercially available adult soft bristle toothbrush
Placebo toothpaste without chlorhexidine and AmClDrug
Negative Control Group assigned to use a placebo toothpaste without chlorhexidine and AmCl and brushing with a commercially available adult soft bristle toothbrush.
| Study group | Role | What they receive |
|---|---|---|
| 0.3% chlorhexidine toothpaste | Experimental | Test group assigned to use a 0.3% chlorhexidine + 3% AmCl toothpaste and brushing with a commercially available adult soft bristle toothbrush Receives: Drug: Chlorhexidine toothpaste; Device: Toothbrush |
| Negative Control | Placebo comparator | Negative Control group assigned to use a placebo toothpaste without chlorhexidine and AmCl and brushing with a commercially available adult soft bristle toothbrush Receives: Device: Toothbrush; Drug: Placebo toothpaste without chlorhexidine and AmCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Löe-Silness Gingival Index
A Löe-Silness Gingival Index score from 0 to 3 will be assigned by the examining dentist to all scorable surfaces of the maxillary and mandibular teeth 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 scorable surface and dividing that number by the total number of surfaces scored.
Measured: 21 days
Secondary outcomes (2)
Modified Quigley-Hein Plaque Index
The Turesky modification of the Quigley-Hein Plaque Index is a method for assessing dental plaque accumulation by scoring plaque presence on six surfaces of each tooth on a scale from 0 to 5.
Measured: 21 days
Lobene Stain index
The labial/lingual surface of each tooth will be divided into two regions: the gingival region, and the body region. The gingival and body regions would be scored separately for yellow stains by use criteria for intensity or severity: 0- no stain, 1- light stain, 2-moderate stain, and 3-heavy stain. The extent to which these yellow stains covered the gingival and body regions will be scored: 0-no stain detected, only tooth color, 1- stain covering up to 1/3 of the region, 2- stain covering from 1/3 to 2/3 of the region, and 3- stain over two thirds of the region. The sum of the stain scores for a subject will be used as that subject's stain score.
Measured: 21 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2024
- Study start24 Mar 2025
- Primary completion15 Apr 2025
- Study completion15 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase III, one-center, parallel group, double blind and randomized trial
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Federal University of Rio Grande do Sul
- Responsible party
- Sponsor
- Investigators
- Cassiano K Rosing, PhD, Principal investigator, Federal University of Rio Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06732466
- Sponsor's protocol ID
- CRO-2024-11-PG-CHX-BZ-CB
- Acronym
- CHX TP
- Status last verified
- Apr 2025
- First submitted
- 10 Dec 2024
- Last updated
- 6 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 6 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Research Study to Evaluate the Effect of a Toothpaste Containing Chlorhexidine 0.3% in Subjects With Established Dental Plaque and Gingivitis
- ClinicalTrials.gov ID
- NCT06732466
- Acronym / sponsor ID
- CHX TP / CRO-2024-11-PG-CHX-BZ-CB
- Keywords
- chlorhexidine, toothpastes, gingivitis, dental plaque
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Collaborators
- Federal University of Rio Grande do Sul
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 15 Apr 2025 (actual)
- First posted
- 13 Dec 2024 (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.
This is a Phase III, one-center, parallel group, double blind, clinical study to evaluate the effect of a toothpaste containing 0.3% chlorhexidine in subjects with established dental plaque and gingivitis. It involves 80 participants aged between 18 and 70, randomly assigned to different groups, and spans 21 days.
Detailed description
This clinical study aims to evaluate the effect of a toothpaste containing 0.3% chlorhexidine in subjects with established dental plaque and gingivitis. It is a Phase III study designed as randomized, one-center, double blind, parallel group trial involving 80 participants aged 18 to 70. Subjects will be divided into two groups: test group - subjects assigned to use a toothpaste with a 0.3% chlorhexidine + 3% AmCl and brush with a commercially available adult soft bristle toothbrush; negative control group - subjects assigned to use a placebo toothpaste without chlorhexidine and AmCl and brush with a commercially available adult soft bristle toothbrush. Subjects will undergo baseline, 14 days and 21 days evaluations. The primary outcome will be reduction of gingival inflammation and data will be analyzed using ANCOVA to assess the efficacy of the test product. Adverse events and compliance will be closely monitored, with strict confidentiality maintained for all participants. The study rigorous design aims to provide comprehensive insights into the effectiveness of the chlorhexidine toothpaste regarding gingivitis and dental plaque control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Phase III, one-center, parallel group, double blind and randomized trial
| Arm | Type | Receives |
|---|---|---|
| 0.3% chlorhexidine toothpaste | Experimental | Drug: Chlorhexidine toothpaste, Device: ToothbrushTest group assigned to use a 0.3% chlorhexidine + 3% AmCl toothpaste and brushing with a commercially available adult soft bristle toothbrush |
| Negative Control | Placebo comparator | Device: Toothbrush, Drug: Placebo toothpaste without chlorhexidine and AmClNegative Control group assigned to use a placebo toothpaste without chlorhexidine and AmCl and brushing with a commercially available adult soft bristle 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)
- Males and females, between 18-70 years of age;
- Availability for the duration of the study;
- Good general health (absence of any condition that, in the opinion of the Principal Investigator, might constitute a risk to the subject while participating in the study. Examples include heart problems, valve/hip replacements, etc);
- Willingness to provide information related to their medical history;
- Minimum of 20 uncrowned permanent natural teeth (excluding third molars and crowns);
Key exclusion criteria (12 listed)
- Absence of visible clinical signs of periodontal disease, such as the presence of suppuration, dental mobility, and/or extensive attachment loss;
- That received dental prophylaxis within 1 month prior to the Baseline visit;
- Oral pathology or a history of allergy to testing products;
- Subject using anticonvulsants, antihistamines, antidepressants, sedatives, tranquilizers, anti-inflammatory medication or daily analgesics within one month prior to the start of the study or scheduled to start such intake during the course of the study; to be defined by the dental examiner;
- Subject participating in any other clinical study;
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 |
|---|---|---|
| Chlorhexidine toothpasteA toothpaste containing 0.3% chlorhexidine + 3% AmCl | Drug | 0.3% chlorhexidine toothpaste |
| ToothbrushCommercially available adult soft bristle toothbrush | Device | 0.3% chlorhexidine toothpaste, Negative Control |
| Placebo toothpaste without chlorhexidine and AmClNegative Control Group assigned to use a placebo toothpaste without chlorhexidine and AmCl and brushing with a commercially available adult soft bristle toothbrush. | Drug | Negative Control |
Primary outcome
Löe-Silness Gingival Index
Time frame: 21 days
A Löe-Silness Gingival Index score from 0 to 3 will be assigned by the examining dentist to all scorable surfaces of the maxillary and mandibular teeth 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 scorable surface and dividing that number by the total number of surfaces scored.
2 secondary outcomes
Modified Quigley-Hein Plaque Index
Time frame: 21 days
Lobene Stain index
Time frame: 21 days
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 6 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.
Cassiano K Rosing, PhD principal investigator
Federal University of Rio Grande do Sul
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 Chlorhexidine toothpaste and Toothbrush in people with Gingivitis and Gingivitis and Periodontal Diseases, run by Colgate Palmolive at 1 site in Brazil.
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 12 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 6 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 Brazil. 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.
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?
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?
Löe-Silness Gingival Index (time frame: 21 days). 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 6 Aug 2025; AzTrials last refreshed its copy on 6 Nov 2026.