Dental PlaquePhase 3WFPOCNCT06607172
Clinical Efficacy of the Combined Effect of Oral Irrigator and Chemicals (0.075% CPC)
A Phase 3 study testing oral irrigator and Cetylpyridinium Chloride (CPC) in people with Dental Plaque and Dental Plaque Induced Gingivitis, run by Colgate Palmolive at 1 site in Brazil.
Trial summary
This is an experimental gingivitis clinical study to evaluate gum health efficacy from the combination effect of water flosser and chemistry (0.075% CPC) compared to water flosser and water and to no oral hygiene regimen with a 3-week follow-up. Thirty participants, aged between 18 and 70, will be enrolled. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque, Dental Plaque Induced Gingivitis, Dental Plaque and Gingivitis
- What is being tested?
- oral irrigator and Cetylpyridinium Chloride (CPC)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteBrazil
- Study dates
- 30 Sep 2024to 22 Oct 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed informed consent form;
- Aged between 18 and 70;
- Available for the three (3) week study duration;
- Good general health for participation in the study, based on the opinion of the study investigator;
- Must have at least 20 natural permanent teeth;
- Teeth must meet the scoring entry criteria for dental plaque and gingivitis (gum inflammation) at the discretion of the study examiner.
Who cannot join
- Medical condition which requires premedication prior to dental visits/procedures;
- Presence of fix/ removable prosthodontics dentures that may interfere with this study clinical examinations;
- Advanced periodontal disease (gum disease) and/or treatment for periodontal disease (including surgery) within the past twelve months;
- Five (5) or more decayed, untreated dental sites (cavities) and/or any dental condition requiring urgent dental care;
- Abnormalities/diseases of the soft or hard oral tissues;
- Orthodontic appliances/bands/lingual bars that interfere with any clinical assessment (plaque scoring)
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- Use of drugs that can affect salivary flow;
- Use of antibiotics three (3) months prior to study entry and/or during participation in this study;
- Use of any over the counter medications other than analgesics that could interfere with the study at PI discretion;
- Self-reported pregnancy and/or breastfeeding;
- Current Participation in another clinical study or during the month prior to this clinical study entry;
- Known allergies and/or reactions to common dentifrice ingredients;
- Medical condition which prohibits not eating/drinking or chewing gum for four (4) hours prior to your scheduled visits;
- Immunocompromised conditions (AIDS, immunosuppressive drug therapy);
- Infectious disease and/or other blood borne diseases (Hepatitis series, HIV, tuberculosis).
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Federal University of Pelotas
Pelotas, Rio Grande do Sul, 96015-560
About this study
Official title: Antiplaque and Antigingivitis Efficacy of the Combined Effect of Oral Irrigator and Chemicals (0.075% CPC): a Randomized Clinical Trial with Experimental Gingivitis Model
This is an experimental gingivitis clinical study to evaluate gum health efficacy from the combination effect of water flosser and chemistry (0.075% CPC) compared to water flosser and water and to no oral hygiene regimen with a 3-week follow-up. Thirty participants, aged between 18 and 70, will be enrolled.
Read the detailed description
This is an examiner blind, randomized controlled, parallel designed clinical study that aims to assess the gum health efficacy (antiplaque and antigingivitis) from the combination effect of water flosser and chemistry (0.075% CPC) compared to water flosser and water and to no oral hygiene in a 3-week experimental gingivitis. Thirty participants will be enrolled and allocated into 3 groups: group I - using a water flosser device and water each time; group II - using a water flosser device and dilutable chemistry product (0.075% CPC) after dilution each time (for groups I an II participants will use this regimen treatment twice daily, in the morning and evening, and no other oral hygiene will be allowed during the 21 days of follow-up); group III - negative control in which participants will abstain for any oral hygiene during the 21 days of follow-up. Gingival index measurements will be the primary efficacy variable after using the assigned regimen for 3 weeks for each subject. Subjects will under go baseline, 3 days, 1, 2 and 3 weeks visits. An Analysis of Covariance will be performed on the final or delta plaque scores using the baseline value as covariate. The F-test in this analysis will test the hypothesis that the waterflosser groups are equal in adjusted means.
- Being tested
- oral irrigator, Cetylpyridinium Chloride (CPC)
- Keywords
- dental hygiene products, gingivitis, dental plaque, oral irrigator
- Medical subject headings
- Dental Plaque, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral irrigatorDevice
water flosser device
oral irrigatorDevice
water flosser and 0.075% CPC
Cetylpyridinium Chloride (CPC)Drug
Cetylpyridinium 0.075%
| Study group | Role | What they receive |
|---|---|---|
| Group II: waterflosser + dilutable 0.075% CPC | Active comparator | Subjects assigned to this group will use a water flosser device and dilutable chemistry product (0.075% CPC) after dilution each time. Water flosser must be used for one minute. They must use this regimen treatment twice daily (in the morning and evening). No other oral hygiene will be allowed during the 21 days of follow-up. Receives: Device: oral irrigator; Drug: Cetylpyridinium Chloride (CPC) |
| Group III: negative control | No intervention | Subjects assigned to this group will abstain for any oral hygiene during the 21 days of follow-up. |
| Group I: water flosser and water | Experimental | Subjects assigned to this group will use a water flosser device and water each time. Water flosser must be used for one minute. They must use this regimen treatment twice daily (in the morning and evening). No other oral hygiene will be allowed during the 21 days of follow-up. Receives: Device: oral irrigator |
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 (0 = absence of inflammation and 3 = severe inflammation) will be assigned by the examining dentist to all scorable surfaces of the maxillary and mandibular teeth (6 sites/tooth) 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: 3 weeks
Secondary outcomes (1)
Navy Plaque Index, Rustogi Modification
The dentition will be disclosed with disclosing solution and plaque scored according to the Refined Navy Plaque Index. This index includes nine surfaces (marked A-I) examined for plaque after staining. Surfaces A, B, C denote the gingival margin surfaces, surfaces D and F the proximal surfaces. The total plaque score range is 0-9, the range for the gingival margin area is 0-3 and for the proximal area 0-2.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2024
- Study start30 Sep 2024
- Primary completion22 Oct 2024
- Study completion22 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental PlaqueStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized, controlled, examiner blind, parallel-group clinical trial
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Federal University of Pelotas
- Responsible party
- Sponsor
- Investigators
- Wilker Muniz, PhD, Principal investigator, Federal University of Pelotas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06607172
- Sponsor's protocol ID
- CRO 2024-06-WF-POC-BZ-CB
- Acronym
- WFPOC
- Status last verified
- Sep 2024
- First submitted
- 12 Sep 2024
- Last updated
- 13 Dec 2024
- 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 13 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antiplaque and Antigingivitis Efficacy of the Combined Effect of Oral Irrigator and Chemicals (0.075% CPC): a Randomized Clinical Trial with Experimental Gingivitis Model
- ClinicalTrials.gov ID
- NCT06607172
- Acronym / sponsor ID
- WFPOC / CRO 2024-06-WF-POC-BZ-CB
- Keywords
- dental hygiene products, gingivitis, dental plaque, oral irrigator
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Collaborators
- Federal University of Pelotas
- Study start
- 30 Sep 2024 (actual)
- Primary completion
- 22 Oct 2024 (actual)
- Study completion
- 22 Oct 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.
This is an experimental gingivitis clinical study to evaluate gum health efficacy from the combination effect of water flosser and chemistry (0.075% CPC) compared to water flosser and water and to no oral hygiene regimen with a 3-week follow-up. Thirty participants, aged between 18 and 70, will be enrolled.
Detailed description
This is an examiner blind, randomized controlled, parallel designed clinical study that aims to assess the gum health efficacy (antiplaque and antigingivitis) from the combination effect of water flosser and chemistry (0.075% CPC) compared to water flosser and water and to no oral hygiene in a 3-week experimental gingivitis. Thirty participants will be enrolled and allocated into 3 groups: group I - using a water flosser device and water each time; group II - using a water flosser device and dilutable chemistry product (0.075% CPC) after dilution each time (for groups I an II participants will use this regimen treatment twice daily, in the morning and evening, and no other oral hygiene will be allowed during the 21 days of follow-up); group III - negative control in which participants will abstain for any oral hygiene during the 21 days of follow-up. Gingival index measurements will be the primary efficacy variable after using the assigned regimen for 3 weeks for each subject. Subjects will under go baseline, 3 days, 1, 2 and 3 weeks visits. An Analysis of Covariance will be performed on the final or delta plaque scores using the baseline value as covariate. The F-test in this analysis will test the hypothesis that the waterflosser groups are equal in adjusted means.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- This is a randomized, controlled, examiner blind, parallel-group clinical trial
| Arm | Type | Receives |
|---|---|---|
| Group II: waterflosser + dilutable 0.075% CPC | Active comparator | Device: oral irrigator, Drug: Cetylpyridinium Chloride (CPC)Subjects assigned to this group will use a water flosser device and dilutable chemistry product (0.075% CPC) after dilution each time. Water flosser must be used for one minute. They must use this regimen treatment twice daily (in the morning and evening). No other oral hygiene will be allowed during the 21 days of follow-up. |
| Group III: negative control | No intervention | –Subjects assigned to this group will abstain for any oral hygiene during the 21 days of follow-up. |
| Group I: water flosser and water | Experimental | Device: oral irrigatorSubjects assigned to this group will use a water flosser device and water each time. Water flosser must be used for one minute. They must use this regimen treatment twice daily (in the morning and evening). No other oral hygiene will be allowed during the 21 days of follow-up. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent form;
- Aged between 18 and 70;
- Available for the three (3) week study duration;
- Good general health for participation in the study, based on the opinion of the study investigator;
- Must have at least 20 natural permanent teeth;
Key exclusion criteria (15 listed)
- Medical condition which requires premedication prior to dental visits/procedures;
- Presence of fix/ removable prosthodontics dentures that may interfere with this study clinical examinations;
- Advanced periodontal disease (gum disease) and/or treatment for periodontal disease (including surgery) within the past twelve months;
- Five (5) or more decayed, untreated dental sites (cavities) and/or any dental condition requiring urgent dental care;
- Abnormalities/diseases of the soft or hard oral tissues;
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 |
|---|---|---|
| oral irrigatorwater flosser device | Device | Group I: water flosser and water |
| oral irrigatorwater flosser and 0.075% CPC | Device | Group II: waterflosser + dilutable 0.075% CPC |
| Cetylpyridinium Chloride (CPC)Cetylpyridinium 0.075% | Drug | Group II: waterflosser + dilutable 0.075% CPC |
Primary outcome
Löe-Silness Gingival Index
Time frame: 3 weeks
A Löe-Silness Gingival Index score from 0 to 3 (0 = absence of inflammation and 3 = severe inflammation) will be assigned by the examining dentist to all scorable surfaces of the maxillary and mandibular teeth (6 sites/tooth) 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.
1 secondary outcome
Navy Plaque Index, Rustogi Modification
Time frame: 3 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 13 Dec 2024.
- 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.
Wilker Muniz, PhD principal investigator
Federal University of Pelotas
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 oral irrigator and Cetylpyridinium Chloride (CPC) in people with Dental Plaque and Dental Plaque Induced Gingivitis, 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 6 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 13 Dec 2024. 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?
Löe-Silness Gingival Index (time frame: 3 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 13 Dec 2024; AzTrials last refreshed its copy on 8 Nov 2026.