GingivitisPhase 3NCT07842978
Clinical Study Examining the Control of Plaque and Gingivitis
A Phase 3 study testing Silica Free Meridol, Meridol and Colgate Dental Product in people with Gingivitis, run by Colgate Palmolive at 1 site in China.
Trial summary
The objective of this six-month clinical investigation is to evaluate the efficacy of a silica-free meridol toothpaste versus Colgate Cavity Protection Toothpaste in the control of established dental plaque and gingivitis. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- Silica Free Meridol, Meridol and Colgate Dental Product
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteChina
- Study dates
- Oct 2026to Apr 2027
- 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
- Subjects, ages 18-70, inclusive.
- Availability for the six-month duration of the clinical research study.
- Good general health.
- Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
- Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
- Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
- Signed Informed Consent Form
Who cannot join
- Presence of orthodontic bands.
- Presence of partial removable dentures.
- Tumor(s) of the soft or hard tissues of the oral cavity.
- Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
- Five or more carious lesions requiring immediate restorative treatment.
- Antibiotic use any time during the one month prior to entry into the study.
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- Participation in any other clinical study or test panel within the one month prior to entry into the study.
- Dental prophylaxis during the past two weeks prior to baseline examinations.
- History of allergies to oral care/personal care consumer products or their ingredients.
- On any prescription medicines that might interfere with the study outcome.
- An existing medical condition which prohibits eating or drinking for periods up to 4 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: A Six-month Clinical Investigation of a Silica-free Meridol Toothpaste Versus Colgate Cavity Protection Toothpaste for the Control of Established Dental Plaque and Gingivitis
The objective of this six-month clinical investigation is to evaluate the efficacy of a silica-free meridol toothpaste versus Colgate Cavity Protection Toothpaste in the control of established dental plaque and gingivitis.
- Conditions
- Gingivitis
- Being tested
- Silica Free Meridol, Meridol, Colgate Dental Product
- Keywords
- plaque
- Medical subject headings
- Gingivitis, Plaque, Amyloid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Silica Free MeridolDrug
Toothpaste
MeridolDrug
Toothpaste
Colgate Dental ProductDrug
MFP fluoride toothpaste
| Study group | Role | What they receive |
|---|---|---|
| Test 1 toothpaste | Experimental | Subjects will be instructed to brush their teeth with the assigned teeth dentifrice and toothbrush twice daily. Receives: Drug: Silica Free Meridol |
| Test 2 toothpaste | Active comparator | Subjects will be instructed to brush their teeth with the assigned teeth dentifrice and toothbrush twice daily. Receives: Drug: Meridol |
| Test 3 toothpaste | Active comparator | Subjects will be instructed to brush their teeth with the assigned teeth dentifrice and toothbrush twice daily. Receives: Drug: Colgate Dental Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingivitis Assessment
A Loe-Silness Gingival Index score from 0 to 3 will be assigned by the examining dentist to all scoreable 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 scoreable surface and dividing that number by the total number of surfaces scored.
0 = Absence of inflammation
- = Mild inflammation - slight change in color and little change in texture
- = Moderate inflammation - moderate glazing, redness, edema and hypertrophy
- = Severe inflammation - marked redness and hypertrophy. Tendency for spontaneous bleeding
Each tooth is scored on six surfaces: mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. The maximum score per tooth, therefore, is 18.
Measured: Baseline, 3 month, 6 month
Quigley-Hein Plaque Index
First using a red solution to dye the plaque, a Quigley-Hein Plaque Index score of 0 to 5 will be assigned to all scoreable disclosed surfaces of the maxillary and mandibular teeth 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.
Measured: Baseline, 3 month, 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionApr 2027 (estimated)
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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Deyu Hu, DDS, MS, Principal investigator, West China Dental Institute of Chengdu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07842978
- Sponsor's protocol ID
- CRO-2026-06-GIN-NOS-YPZ
- Status last verified
- Sep 2026
- First submitted
- 21 Sep 2026
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Six-month Clinical Investigation of a Silica-free Meridol Toothpaste Versus Colgate Cavity Protection Toothpaste for the Control of Established Dental Plaque and Gingivitis
- ClinicalTrials.gov ID
- NCT07842978
- Acronym / sponsor ID
- CRO-2026-06-GIN-NOS-YPZ
- Conditions
- Gingivitis
- Keywords
- plaque
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- Apr 2027 (estimated)
- First posted
- 25 Sep 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.
The objective of this six-month clinical investigation is to evaluate the efficacy of a silica-free meridol toothpaste versus Colgate Cavity Protection Toothpaste in the control of established dental plaque and gingivitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Test 1 toothpaste | Experimental | Drug: Silica Free MeridolSubjects will be instructed to brush their teeth with the assigned teeth dentifrice and toothbrush twice daily. |
| Test 2 toothpaste | Active comparator | Drug: MeridolSubjects will be instructed to brush their teeth with the assigned teeth dentifrice and toothbrush twice daily. |
| Test 3 toothpaste | Active comparator | Drug: Colgate Dental ProductSubjects will be instructed to brush their teeth with the assigned teeth dentifrice and toothbrush twice daily. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Subjects, ages 18-70, inclusive.
- Availability for the six-month duration of the clinical research study.
- Good general health.
- Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
- Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
Key exclusion criteria (11 listed)
- Presence of orthodontic bands.
- Presence of partial removable dentures.
- Tumor(s) of the soft or hard tissues of the oral cavity.
- Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
- Five or more carious lesions requiring immediate restorative treatment.
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 |
|---|---|---|
| Silica Free MeridolToothpaste | Drug | Test 1 toothpaste |
| MeridolToothpaste | Drug | Test 2 toothpaste |
| Colgate Dental ProductMFP fluoride toothpaste | Drug | Test 3 toothpaste |
Primary outcome
Gingivitis Assessment
Time frame: Baseline, 3 month, 6 month
A Loe-Silness Gingival Index score from 0 to 3 will be assigned by the examining dentist to all scoreable 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 scoreable surface and dividing that number by the total number of surfaces scored. 0 = Absence of inflammation 1. = Mild inflammation - slight change in color and little change in texture 2. = Moderate inflammation - moderate glazing, redness, edema and hypertrophy 3. = Severe inflammation - marked redness and hypertrophy. Tendency for spontaneous bleeding Each tooth is scored on six surfaces: mesio-facial; 2) mid-facial; 3) disto-facial; 4) mesio-lingual; 5) mid-lingual; and 6) disto-lingual. The maximum score per tooth, therefore, is 18.
Quigley-Hein Plaque Index
Time frame: Baseline, 3 month, 6 month
First using a red solution to dye the plaque, a Quigley-Hein Plaque Index score of 0 to 5 will be assigned to all scoreable disclosed surfaces of the maxillary and mandibular teeth 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.
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 25 Sep 2026.
- 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.
Deyu Hu, DDS, MS 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 Silica Free Meridol, Meridol and Colgate Dental Product in people with 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 7 inclusion and 11 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 25 Sep 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, MS (86-1390-803-4990, hudeyu@vip.sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingivitis Assessment (time frame: Baseline, 3 month, 6 month). 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 25 Sep 2026.