Gingival BleedingPhase 3PGMWIINCT06598072
Comparative Study to Evaluate the Efficacy of an Alcohol-free Mouthwash Regimen With CPC+Zn, Flossing and Brushing, and an Alcohol-based Mouthwash Regimen With Essential Oils in Reducing Plaque and Gingivitis.
A Phase 3 study testing Mouthwash CPC+Zn+F, Essential oils mouthwash and Dental floss in people with Gingival Bleeding and Plaque Induced Gingival Disease, run by Colgate Palmolive at 1 site in Mexico.
Trial summary
This is a Phase III, randomized, one-center, parallel group, double blinded, clinical study to evaluate the efficacy of 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 more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Gingival Bleeding, Plaque Induced Gingival Disease, Gingival Diseases
- What is being tested?
- Mouthwash CPC+Zn+F, Essential oils mouthwash 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 siteMexico
- Study dates
- 17 Sep 2024to 16 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; At least 20 teeth with scorable facial and lingual surfaces; evidence of gingivitis; At least 10 bleeding sites based on the Bleeding Index (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
- No sites with more than 5 mm probing depth, and a maximum of three sites of 5 mm probing depth.
- Have 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; 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.
Mexico1 site
Universidad Autónoma de San Luis Potosí
San Luis Potosí City, San Luis Potosí, 78000
About this study
Official title: Clinical Study to Evaluate the Efficacy of a Regimen Including Rinsing With an Alcohol Free Mouthwash Containing CPC+Zn as Compared to Dental Flossing and Brushing and a Regimen Including Rising With an Essential Oils Containing Alcohol Mouthwash in Reducing Dental Plaque and Gingivitis.
This is a Phase III, randomized, one-center, parallel group, double blinded, clinical study to evaluate the efficacy of 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. One hundred and twenty participants, aged between 18 and 65 years, will be included and followed for 12 weeks.
Read the detailed description
This clinical study aims to evaluate the efficacy of a regimen including an alcohol-free mouthwash containing CPC+Zn as compared to dental flossing and brushing and to a regimen including a rinsing with an essential oils containing alcohol mouthwash in reducing dental plaque and gingivitis. This is a Phase III, randomized, one-center, parallel group, double blinded, involving 120 participants, aged 18 to 65. Subjects will be allocated into 3 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, Gingival Diseases, Gingivitis and Periodontal Diseases
- Being tested
- Mouthwash CPC+Zn+F, Essential oils mouthwash, Dental floss
- Keywords
- gingivitis, dental plaque
- Medical subject headings
- Gingival Hemorrhage, Gingival Diseases, 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 mouthwashDrug
Essential oils mouthwash
Dental flossDevice
Dental Floss
| Study group | Role | What they receive |
|---|---|---|
| CPC+Zn mouthwash and brushing | Experimental | A regimen composing of a CPC+Zn mouthwash, brushing with a commercially available toothbrush and a stannous fluoride-based toothpaste Receives: Drug: Mouthwash CPC+Zn+F |
| Essential oils mouthwash and brushing | Active comparator | A regimen composing of an essential oils mouthwash, brushing with a commercially available toothbrush and a fluoride-based toothpaste Receives: Drug: Essential oils mouthwash |
| Flossing and brushing | Active comparator | A regimen composing of flossing and brushing with a commercially available toothbrush and a fluoride-based toothpaste Receives: Device: Dental floss |
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 used to evaluate the severity of gingivitis by measuring the extent of gingival inflammation. It categorizes gingival health/inflammation 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.
- First posted19 Sep 2024
- Study start17 Sep 2024
- Primary completion16 Dec 2024
- Study completion16 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)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Universidad Autonoma de San Luis Potosí
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06598072
- Sponsor's protocol ID
- CRO-2024-08-PG-MWII-MX-CB
- Acronym
- PGMWII
- 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
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 a Regimen Including Rinsing With an Alcohol Free Mouthwash Containing CPC+Zn as Compared to Dental Flossing and Brushing and a Regimen Including Rising With an Essential Oils Containing Alcohol Mouthwash in Reducing Dental Plaque and Gingivitis.
- ClinicalTrials.gov ID
- NCT06598072
- Acronym / sponsor ID
- PGMWII / CRO-2024-08-PG-MWII-MX-CB
- Conditions
- Gingival Bleeding, Plaque Induced Gingival Disease, Gingival Diseases, Gingivitis and Periodontal Diseases
- Keywords
- gingivitis, dental plaque
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Collaborators
- Universidad Autonoma de San Luis Potosí
- Study start
- 17 Sep 2024 (actual)
- Primary completion
- 16 Dec 2024 (actual)
- Study completion
- 16 Dec 2024 (actual)
- First posted
- 19 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.
This is a Phase III, randomized, one-center, parallel group, double blinded, clinical study to evaluate the efficacy of 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. One hundred and twenty participants, aged between 18 and 65 years, will be included and followed for 12 weeks.
Detailed description
This clinical study aims to evaluate the efficacy of a regimen including an alcohol-free mouthwash containing CPC+Zn as compared to dental flossing and brushing and to a regimen including a rinsing with an essential oils containing alcohol mouthwash in reducing dental plaque and gingivitis. This is a Phase III, randomized, one-center, parallel group, double blinded, involving 120 participants, aged 18 to 65. Subjects will be allocated into 3 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.
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 and brushing | Experimental | Drug: Mouthwash CPC+Zn+FA regimen composing of a CPC+Zn mouthwash, brushing with a commercially available toothbrush and a stannous fluoride-based toothpaste |
| Essential oils mouthwash and brushing | Active comparator | Drug: Essential oils mouthwashA regimen composing of an essential oils mouthwash, brushing with a commercially available toothbrush and a fluoride-based toothpaste |
| Flossing and brushing | Active comparator | Device: Dental flossA regimen composing of flossing and brushing with a commercially available toothbrush and a fluoride-based toothpaste |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 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; At least 20 teeth with scorable facial and lingual surfaces; evidence of gingivitis; At least 10 bleeding sites based on the Bleeding Index (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.
Key exclusion criteria (2 listed)
- No sites with more than 5 mm probing depth, and a maximum of three sites of 5 mm probing depth.
- Have 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; 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
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 and brushing |
| Essential oils mouthwashEssential oils mouthwash | Drug | Essential oils mouthwash and brushing |
| Dental flossDental Floss | Device | Flossing and brushing |
Primary outcome
Modified Gingival Index
Time frame: 12 weeks
The Modified Gingival Index (MGI) is used to evaluate the severity of gingivitis by measuring the extent of gingival inflammation. It categorizes gingival health/inflammation 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.
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 Phase 3 study testing Mouthwash CPC+Zn+F, Essential oils mouthwash and Dental floss in people with Gingival Bleeding and Plaque Induced Gingival Disease, run by Colgate Palmolive at 1 site in Mexico.
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 1 inclusion and 2 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 Mexico. 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?
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.