Gingival BleedingPhase 3PGMWINCT06607263

Comparative Study of CPC+Zn Mouthwash, Dental Floss, and Essential Oils Mouthwash on Plaque and Gingivitis Reduction

A Phase 3 study testing Mouthwash CPC+Zn+F, Essential oils mouthrinse and Dental floss in people with Gingival Bleeding and Plaque Induced Gingival Disease, run by Colgate Palmolive at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Clinical study evaluating the effectiveness of an alcohol-free mouthwash containing CPC+Zn compared to dental flossing and an essential oils-containing alcohol mouthwash in reducing dental plaque and gingivitis. This is a Phase III, single-center, double-blind trial with a parallel design. Read more about this study

Who is it for?: Ages 18 to 65 years
Conditions the study is for: Gingival Bleeding, Plaque Induced Gingival Disease, Gingivitis and Periodontal Diseases
What is being tested?: Mouthwash CPC+Zn+F, Essential oils mouthrinse and Dental floss
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 120 participants
Where: 1 siteBrazil
Study dates: 16 Sep 2024to 9 Dec 2024
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 65 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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;
≥20 teeth with scorable facial and lingual surfaces; evidence of gingivitis;
≥10 bleeding sites based on the BI
Initial mean gingivitis index of at least 1.5 as determined by the use of the Modified Gingival Index (MGI).
Subjects without allergies to the products that are being tested;
Informed Consent Form signed.

Who cannot join

That received dental prophylaxis within 1 month prior to the Baseline visit;
Need for antibiotics prior to dental treatment; use of antibiotics, anti-inflammatory or anticoagulant therapy during the three months prior to entry into the study;
Usage of oral care products containing chemotherapeutic products within 2 weeks prior to Baseline;
Use of smokeless tobacco;
Any other condition that would make the volunteer inappropriate for the study.
Oral pathology, chronic disease, or a history of allergy to testing products;

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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;
Subject participating in any other clinical study;
Subject pregnant or breastfeeding;
Subject allergic to oral care products, personal care consumer products, or their ingredients;
Ongoing use of medications known to affect the gingival tissues (i.e. calcium channel blockers, phenytoin, cyclosporine);
Periodontal treatment 12 months before the beginning of the study;
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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

Federal University of Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90010-150

Other trials in Brazil

About this study

Official title: Clinical Study to Evaluate the Efficacy of Rinsing With an Alcohol Free Mouthwash Containing CPC+Zn as Compared to Dental Flossing and to Rising With an Essential Oils Containing Alcohol Mouthwash in Reducing Dental Plaque and Gingivitis.

Read the detailed description

This clinical study aims to evaluate the efficacy of an alcohol-free mouthwash containing CPC (Cetylpyridinium Chloride) and Zinc (Zn) in reducing dental plaque and gingivitis compared to dental flossing and a mouthwash with essential oils in an alcohol base. It is a Phase III, randomized, double-blind, parallel-group trial involving 120 participants aged 18 to 65. Subjects will be divided into three groups-one using the CPC+Zn mouthwash, another using the essential oils mouthwash, and a control group using dental floss. Each group will also use a fluoride toothpaste and a soft-bristle toothbrush twice daily over 12 weeks. The primary efficacy variable is the reduction of gingival inflammation also Probing Depth, Bleeding on Probing, and a Plaque Index will be accessed. Subjects will undergo baseline, 4-week, and 12-week evaluations, with data analyzed using ANCOVA to assess the efficacy and safety of the products. 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 these oral hygiene regimens.

Conditions: Gingival Bleeding, Plaque Induced Gingival Disease, Gingivitis and Periodontal Diseases
Being tested: Mouthwash CPC+Zn+F, Essential oils mouthrinse, Dental floss, Toothpaste, Toothbrush
Keywords: dental plaque, gingivitis
Medical subject headings: Gingival Hemorrhage, Gingivitis, Periodontal Diseases, Dental Plaque

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mouthwash CPC+Zn+FDrug
Also called CPC+Zn
A mouthwash containing CPC + Zn and fluoride
Essential oils mouthrinseDrug
Essential oils mouthrinse
Dental flossDevice
Dental floss
ToothpasteDrug
A commercially available fluoride toothpaste
ToothbrushDevice
A commercially available adult toothbrush

Study groups in NCT06607263
Study group	Role	What they receive
CPC + Zn mouthwash + Brushing	Experimental	A regimen composing a CPC + Zn mouthwash + Brushing with a fluoride toothpaste and a commercially available toothbrush Receives: Drug: Mouthwash CPC+Zn+F; Drug: Toothpaste; Device: Toothbrush
Essential oils mouthwash + Brushing	Active comparator	A regimen composing a essential oils mouthwash + Brushing with a fluoride toothpaste and a commercially available toothbrush Receives: Drug: Essential oils mouthrinse; Drug: Toothpaste; Device: Toothbrush
Flossing + Brushing	Active comparator	A regimen composing flossing + Brushing with a fluoride toothpaste and a commercially available toothbrush Receives: Device: Dental floss; Drug: Toothpaste; Device: Toothbrush

What is being measured

The primary outcome is the main question the study is designed to answer.

Modified Gingival Index
The Modified Gingival Index (MGI) is a clinical assessment tool used to evaluate the severity of gingivitis by measuring the extent of gingival inflammation. It categorizes gingival health on a scale from 0 to 4, where 0 signifies normal gingiva with no inflammation, and 4 indicates severe inflammation characterized by erythema, edema, and spontaneous bleeding.
Measured: 12 weeks

Secondary outcomes (3)

Turesky modification of 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: 12 weeks
Bleeding on probing
Bleeding on probing (BOP) is a diagnostic technique used to assess gingival inflammation by gently probing the gum tissue; the presence of bleeding indicates inflammation and potential periodontal disease.
Measured: 12 weeks
Probing depth
Probing depth measures the distance between the gingival margin and the bottom of the periodontal pocket using a calibrated periodontal probe, indicating the severity of periodontal disease.
Measured: 12 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

16 Sep 20249 Dec 2024

First posted23 Sep 2024
Study start16 Sep 2024
Primary completion9 Dec 2024
Study completion9 Dec 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Gingival BleedingStudies 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: This is a Phase III, randomized, controlled, double-blind, parallel-group clinical trial
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06607263
Sponsor's protocol ID: CRO-2024-08-PG-MWI-BZ-CB
Acronym: PGMWI
Status last verified: Apr 2025
First submitted: 12 Sep 2024
Last updated: 14 Apr 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Microbiome, Cytokines
Recruiting
Oral Health Intervention in Adult Primary Care
Dental Caries, Dry Mouth
Not yet recruiting
Individualized Management of Plaque-Related Gingival Inflammation in Routine Dental Practice
Plaque-Induced Gingivitis
RecruitingObservational study
Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
Diabete Mellitus, Dyslipidaemia
Not yet recruiting
Effectiveness of Interactive Techniques on Oral Hygiene Skills in a Group of Autistic Egyptian Children
Autism Disorder, Autism Spectrum Disorder (ASD

All Gingival Bleeding trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study to Evaluate the Efficacy of Rinsing With an Alcohol Free Mouthwash Containing CPC+Zn as Compared to Dental Flossing and to Rising With an Essential Oils Containing Alcohol Mouthwash in Reducing Dental Plaque and Gingivitis.
ClinicalTrials.gov ID: NCT06607263
Acronym / sponsor ID: PGMWI / CRO-2024-08-PG-MWI-BZ-CB
Conditions: Gingival Bleeding, Plaque Induced Gingival Disease, Gingivitis and Periodontal Diseases
Keywords: dental plaque, gingivitis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: Colgate PalmoliveIndustry (pharma, biotech, devices)
Collaborators: Federal University of Rio Grande do Sul
Study start: 16 Sep 2024 (actual)
Primary completion: 9 Dec 2024 (actual)
Study completion: 9 Dec 2024 (actual)
First posted: 23 Sep 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.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 3
Model description: This is a Phase III, randomized, controlled, double-blind, parallel-group clinical trial

Arm	Type	Receives
CPC + Zn mouthwash + Brushing	Experimental	Drug: Mouthwash CPC+Zn+F, Drug: Toothpaste, Device: ToothbrushA regimen composing a CPC + Zn mouthwash + Brushing with a fluoride toothpaste and a commercially available toothbrush
Essential oils mouthwash + Brushing	Active comparator	Drug: Essential oils mouthrinse, Drug: Toothpaste, Device: ToothbrushA regimen composing a essential oils mouthwash + Brushing with a fluoride toothpaste and a commercially available toothbrush
Flossing + Brushing	Active comparator	Device: Dental floss, Drug: Toothpaste, Device: ToothbrushA regimen composing flossing + Brushing with a fluoride toothpaste and a commercially available toothbrush

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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;
≥20 teeth with scorable facial and lingual surfaces; evidence of gingivitis;
≥10 bleeding sites based on the BI

Key exclusion criteria (14 listed)

That received dental prophylaxis within 1 month prior to the Baseline visit;
Need for antibiotics prior to dental treatment; use of antibiotics, anti-inflammatory or anticoagulant therapy during the three months prior to entry into the study;
Usage of oral care products containing chemotherapeutic products within 2 weeks prior to Baseline;
Use of smokeless tobacco;
Any other condition that would make the volunteer inappropriate for the 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
Mouthwash CPC+Zn+FAlso: CPC+ZnA mouthwash containing CPC + Zn and fluoride	Drug	CPC + Zn mouthwash + Brushing
Essential oils mouthrinseEssential oils mouthrinse	Drug	Essential oils mouthwash + Brushing
Dental flossDental floss	Device	Flossing + Brushing
ToothpasteA commercially available fluoride toothpaste	Drug	CPC + Zn mouthwash + Brushing, Essential oils mouthwash + Brushing, Flossing + Brushing
ToothbrushA commercially available adult toothbrush	Device	CPC + Zn mouthwash + Brushing, Essential oils mouthwash + Brushing, Flossing + Brushing

Primary outcome

Modified Gingival Index
Time frame: 12 weeks
The Modified Gingival Index (MGI) is a clinical assessment tool used to evaluate the severity of gingivitis by measuring the extent of gingival inflammation. It categorizes gingival health on a scale from 0 to 4, where 0 signifies normal gingiva with no inflammation, and 4 indicates severe inflammation characterized by erythema, edema, and spontaneous bleeding.

3 secondary outcomes

Turesky modification of Quigley-Hein Plaque Index
Time frame: 12 weeks
Bleeding on probing
Time frame: 12 weeks
Probing depth
Time frame: 12 weeks

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 14 Apr 2025.
Individual participant dataSharing planned: No

Related trials for Gingival Bleeding

Enrolling by invitation
Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolerance in People With Gingivitis
Microbiome, Cytokines
Recruiting
Oral Health Intervention in Adult Primary Care
Dental Caries, Dry Mouth
Not yet recruiting
Individualized Management of Plaque-Related Gingival Inflammation in Routine Dental Practice
Plaque-Induced Gingivitis
RecruitingObservational study
Prevalence and Associated Factors of High BMI and Periodontitis in Thai Adults Aged Under 60 Years
Diabete Mellitus, Dyslipidaemia
Not yet recruiting
Effectiveness of Interactive Techniques on Oral Hygiene Skills in a Group of Autistic Egyptian Children
Autism Disorder, Autism Spectrum Disorder (ASD

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?

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 14 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 14 Apr 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. 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?

Modified Gingival Index (time frame: 12 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06607263.

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 14 Apr 2025.