Dental PlaquePhase 4NCT07029438
Comparative Efficacy of Floss and Essential Oil/CPC+Zn Mouthwashes in Reducing Dental Plaque and Gingivitis
A Phase 4 study testing Mouthwash, Floss and Toothbrush in people with Dental Plaque and Gingivitis, run by Colgate Palmolive at 1 site in United States.
Trial summary
The objective of this clinical research study is to evaluate the efficacy of floss to an essential oil alcohol-containing mouthwash, an essential oil alcohol-free mouthwash, and a CPC+Zn alcohol-free mouthwash in reducing dental plaque and gingivitis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque, Gingivitis
- What is being tested?
- Mouthwash, Floss and Toothbrush
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 228 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2025to 16 Oct 2025
- Phase
- Phase 4
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female volunteers at least 18 years of age and in general good health.
- Willing and able to understand and sign the informed consent form.
- Whole mouth mean MGI ≥1.95, whole mouth mean TPI≥1.95, and ≥10% bleeding sites
- Be willing to conform to the study protocol and procedures.
- No sites with probing depth >4 mm.
- Minimum of 20 natural teeth with scorable facial and lingual surfaces
Who cannot join
- Medical condition which requires premedication prior to dental visits/procedure.
- Known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the study examiner.
- Active disease of the hard oral tissues.
- Significant oral soft tissue pathology, excluding plaque-induced gingivitis.
- Moderate to severe periodontitis (stages II-IV) per the EFP S3 guidelines.
- Subjects with fixed or removable orthodontic appliances or removable partial dentures.
Show all 17Show fewer
- Dental prophylaxis within 30 days prior to study start.
- Use of antibiotics, antimicrobial drugs, anti-inflammatory drugs, or anticoagulant therapies within 30 days prior to study start.
- Use of chemotherapeutic oral care products within two weeks prior to study start.
- Participation in any other clinical study within 30 days prior to enrollment into this study.
- Subjects who must receive dental treatment during the study dates.
- Immunocompromised individuals (HIV, AIDS, immunosuppressive drug therapy).
- Use of smokeless tobacco, vaping, or e-cigarettes or suspected substance abuse.
- Current smokers (if former smoker, should have stopped at least 1 month prior to Visit 1)
- Pregnant or lactating subjects, or subjects planning to become pregnant during the course of the study.
- Medical condition which prohibits not eating/drinking or chewing gum for four (4) hours prior to your scheduled visits;
- Subjects who have an infectious disease and/or other blood borne diseases (Hepatitis series, HIV, tuberculosis).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Clinical Study to Evaluate the Comparative Efficacy of Floss, Essential Oil Mouthwashes, and an Alcohol-free CPC+Zn Mouthwash in Reducing Dental Plaque and Gingivitis
The objective of this clinical research study is to evaluate the efficacy of floss to an essential oil alcohol-containing mouthwash, an essential oil alcohol-free mouthwash, and a CPC+Zn alcohol-free mouthwash in reducing dental plaque and gingivitis.
- Conditions
- Dental Plaque, Gingivitis
- Being tested
- Mouthwash, Floss, Toothbrush, Toothpaste
- 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.
MouthwashDrug
Antiplaque/Antigingivitis Mouthwash
FlossDevice
Dental Floss
ToothbrushDevice
Soft bristled, manual toothbrush
ToothpasteDrug
Sodium Monofluorophosphate 0.76 % (0.15% w/v fluoride ion) toothpaste
| Study group | Role | What they receive |
|---|---|---|
| Brushing | Placebo comparator | Subjects will brush their teeth in their usual manner for 1 timed minute twice daily with the toothbrush and toothpaste provided. They will apply the toothpaste on the full length of the toothbrush. This arm will be the negative control arm (placebo comparator). Receives: Device: Toothbrush; Drug: Toothpaste |
| Brushing and Flossing | Experimental | Subjects will brush their teeth in their usual manner for 1 timed minute twice daily with the toothbrush and toothpaste provided. They will apply the toothpaste on the full length of the toothbrush. Subjects will floss their teeth after their first brushing instance of the day per instructed method from the study site. Receives: Device: Floss; Device: Toothbrush; Drug: Toothpaste |
| Brushing and Rinsing A | Experimental | Subjects will brush their teeth in their usual manner for 1 timed minute twice daily with the toothbrush and toothpaste provided. They will apply the toothpaste on the full length of the toothbrush. After both brushing instances, subjects will rinse full strength with 20 mL of Mouthwash A for 30 timed seconds. Receives: Drug: Mouthwash; Device: Toothbrush; Drug: Toothpaste |
| Brushing and Rinsing B | Experimental | Subjects will brush their teeth in their usual manner for 1 timed minute twice daily with the toothbrush and toothpaste provided. They will apply the toothpaste on the full length of the toothbrush. After both brushing instances, subjects will rinse full strength with 20 mL of Mouthwash B for 30 timed seconds. Receives: Drug: Mouthwash; Device: Toothbrush; Drug: Toothpaste |
| Brushing and Rinsing C | Experimental | Subjects will brush their teeth in their usual manner for 1 timed minute twice daily with the toothbrush and toothpaste provided. They will apply the toothpaste on the full length of the toothbrush. After both brushing instances, subjects will rinse full strength with 20 mL of Mouthwash C for 30 timed seconds. Receives: Drug: Mouthwash; Device: Toothbrush; Drug: Toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interproximal mean Modified Gingival Index (MGI)
MGI will be visually assessed for six sites for each graded tooth (mesiofacial, facial, distofacial, mesiolingual, lingual, distolingual). Interproximal MGI includes the mesiofacial, distofacial, mesiolingual, and distolingual sites. Higher scores indicate a worse outcome, per below.
0 = no inflammation; no redness
- = mild inflammation; slight changes in color and texture, but not in all portions of gingival marginal or papillary
- = mild inflammation; slight changes in color and texture in all portions of gingival margin or papillary
- = moderate inflammation; bright surface inflammation, erythema, edema, and/or hypertrophy of gingival marginal or papillary
- = severe inflammation; erythema, edema, and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion, or ulceration
Measured: 12 weeks
Secondary outcomes (9)
Whole Mouth mean Modified Gingival Index (MGI)
MGI will be visually assessed for six sites for each graded tooth (mesiofacial, facial, distofacial, mesiolingual, lingual, distolingual). Whole Mouth MGI includes all six sites. Higher scores indicate a worse outcome, per below.
0 = no inflammation; no redness
- = mild inflammation; slight changes in color and texture, but not in all portions of gingival marginal or papillary
- = mild inflammation; slight changes in color and texture in all portions of gingival margin or papillary
- = moderate inflammation; bright surface inflammation, erythema, edema, and/or hypertrophy of gingival marginal or papillary
- = severe inflammation; erythema, edema, and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion, or ulceration
Measured: 1, 4, and 12 weeks
Interproximal mean Turesky Modification of the Quigley-Hein Plaque Index (TPI)
Dental plaque will be assessed at six sites for each graded tooth (mesiofacial, facial, distofacial, mesiolingual, lingual, distolingual) and scored as follows:
0=No plaque
- Separate flecks of plaque at the cervical margin
- A thin, continuous band of plaque (up to 1 mm) at the cervical margin
- A band of plaque wider than 1 mm, but covering less than 1/3 of the side of the crown of the tooth
- Plaque covering at least 1/3, but less than 2/3 of the side of the crown of the tooth
- Plaque covering 2/3 or more of the side of the crown of the tooth
Interproximal mean includes mesiofacial, distofacial, mesiolingual, and distolingual sites. Higher scores indicate a worse outcome, per above.
Measured: 1, 4, and 12 weeks
Whole Mouth mean Turesky Modification of the Quigley-Hein Plaque Index (TPI)
Dental plaque will be assessed at six sites for each graded tooth (mesiofacial, facial, distofacial, mesiolingual, lingual, distolingual) and scored as follows:
0=No plaque
- Separate flecks of plaque at the cervical margin
- A thin, continuous band of plaque (up to 1 mm) at the cervical margin
- A band of plaque wider than 1 mm, but covering less than 1/3 of the side of the crown of the tooth
- Plaque covering at least 1/3, but less than 2/3 of the side of the crown of the tooth
- Plaque covering 2/3 or more of the side of the crown of the tooth
Whole Mouth mean includes all six sites. Higher scores indicate a worse outcome, per above.
Measured: 1, 4, and 12 weeks
Interproximal mean Expanded Bleeding Index (EBI)
EBI will be assessed at six sites for each graded tooth (mesiofacial, facial, distofacial, mesiolingual, lingual, distolingual) by engaging a probe 1 mm into the gingival crevice and applying moderate pressure whilst sweeping from interproximal to interproximal along the sulcular epithelium. Interproximal mean includes mesiofacial, distofacial, mesiolingual, and distolingual sites. A higher score indicates a worse outcome, per below.
0 = no bleeding after 30 seconds
- = bleeding upon probing after 30 seconds
- = immediate bleeding observed
Measured: 1, 4, and 12 weeks
Whole Mouth Expanded Bleeding Index (EBI)
EBI will be assessed at six sites for each graded tooth (mesiofacial, facial, distofacial, mesiolingual, lingual, distolingual) by engaging a probe 1 mm into the gingival crevice and applying moderate pressure whilst sweeping from interproximal to interproximal along the sulcular epithelium. Whole Mouth mean includes all six sites. A higher score indicates a worse outcome, per below.
0 = no bleeding after 30 seconds
- = bleeding upon probing after 30 seconds
- = immediate bleeding observed
Measured: 1, 4, and 12 weeks
Interproximal mean Bleeding on Probing (BOP)
Bleeding on probing will be assessed at six sites for each graded tooth (mesiofacial, facial, distofacial, mesiolingual, lingual, distolingual) and scored as 1 = yes bleeding, 0 = no bleeding. Interproximal mean includes mesiofacial, distofacial, mesiolingual, and distolingual sites. A higher score indicates a worse outcome.
Measured: 12 weeks
Whole Mouth mean Bleeding on Probing (BOP)
Bleeding on probing will be assessed at six sites for each graded tooth (mesiofacial, facial, distofacial, mesiolingual, lingual, distolingual) and scored as 1 = yes bleeding, 0 = no bleeding. Whole Mouth mean includes all six sites. A higher score indicates a worse outcome.
Measured: 12 weeks
Interproximal mean Probing Depth (PD)
Probing depth will be measured at six sites for each graded tooth (mesiofacial, facial, distofacial, mesiolingual, lingual, distolingual) using a calibrated periodontal probe to ensure precision and consistency. Interproximal mean includes mesiofacial, distofacial, mesiolingual, and distolingual sites.
Measurements will be recorded to the nearest millimeter, with particular attention to maintaining gentle and consistent pressure to avoid measurement variability. Larger measurements indicate a worse condition.
Measured: 12 weeks
Whole Mouth mean Probing Depth (PD)
Probing depth will be measured at six sites for each graded tooth (mesiofacial, facial, distofacial, mesiolingual, lingual, distolingual) using a calibrated periodontal probe to ensure precision and consistency. Interproximal mean includes mesiofacial, distofacial, mesiolingual, and distolingual sites.
Measurements will be recorded to the nearest millimeter, with particular attention to maintaining gentle and consistent pressure to avoid measurement variability. Larger measurements indicate a worse condition.
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 Jun 2025
- Study start7 Jul 2025
- Primary completion16 Oct 2025
- Study completion16 Oct 2025
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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffery Milleman, DDS, MPA, Principal investigator, Salus Research, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07029438
- Sponsor's protocol ID
- CRO-2025-FlossRinse-PG-GJ
- Status last verified
- Jun 2025
- First submitted
- 29 May 2025
- Last updated
- 30 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study to Evaluate the Comparative Efficacy of Floss, Essential Oil Mouthwashes, and an Alcohol-free CPC+Zn Mouthwash in Reducing Dental Plaque and Gingivitis
- ClinicalTrials.gov ID
- NCT07029438
- Acronym / sponsor ID
- CRO-2025-FlossRinse-PG-GJ
- Conditions
- Dental Plaque, Gingivitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- 7 Jul 2025 (actual)
- Primary completion
- 16 Oct 2025 (actual)
- Study completion
- 16 Oct 2025 (actual)
- First posted
- 19 Jun 2025 (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 clinical research study is to evaluate the efficacy of floss to an essential oil alcohol-containing mouthwash, an essential oil alcohol-free mouthwash, and a CPC+Zn alcohol-free mouthwash in reducing dental plaque and gingivitis.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Brushing | Placebo comparator | Device: Toothbrush, Drug: ToothpasteSubjects will brush their teeth in their usual manner for 1 timed minute twice daily with the toothbrush and toothpaste provided. They will apply the toothpaste on the full length of the toothbrush. This arm will be the negative control arm (placebo comparator). |
| Brushing and Flossing | Experimental | Device: Floss, Device: Toothbrush, Drug: ToothpasteSubjects will brush their teeth in their usual manner for 1 timed minute twice daily with the toothbrush and toothpaste provided. They will apply the toothpaste on the full length of the toothbrush. Subjects will floss their teeth after their first brushing instance of the day per instructed method from the study site. |
| Brushing and Rinsing A | Experimental | Drug: Mouthwash, Device: Toothbrush, Drug: ToothpasteSubjects will brush their teeth in their usual manner for 1 timed minute twice daily with the toothbrush and toothpaste provided. They will apply the toothpaste on the full length of the toothbrush. After both brushing instances, subjects will rinse full strength with 20 mL of Mouthwash A for 30 timed seconds. |
| Brushing and Rinsing B | Experimental | Drug: Mouthwash, Device: Toothbrush, Drug: ToothpasteSubjects will brush their teeth in their usual manner for 1 timed minute twice daily with the toothbrush and toothpaste provided. They will apply the toothpaste on the full length of the toothbrush. After both brushing instances, subjects will rinse full strength with 20 mL of Mouthwash B for 30 timed seconds. |
| Brushing and Rinsing C | Experimental | Drug: Mouthwash, Device: Toothbrush, Drug: ToothpasteSubjects will brush their teeth in their usual manner for 1 timed minute twice daily with the toothbrush and toothpaste provided. They will apply the toothpaste on the full length of the toothbrush. After both brushing instances, subjects will rinse full strength with 20 mL of Mouthwash C for 30 timed seconds. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female volunteers at least 18 years of age and in general good health.
- Willing and able to understand and sign the informed consent form.
- Whole mouth mean MGI ≥1.95, whole mouth mean TPI≥1.95, and ≥10% bleeding sites
- Be willing to conform to the study protocol and procedures.
- No sites with probing depth >4 mm.
Key exclusion criteria (17 listed)
- Medical condition which requires premedication prior to dental visits/procedure.
- Known history of allergy to personal care/consumer products or their ingredients, relevant to any ingredients in the test products as determined by the study examiner.
- Active disease of the hard oral tissues.
- Significant oral soft tissue pathology, excluding plaque-induced gingivitis.
- Moderate to severe periodontitis (stages II-IV) per the EFP S3 guidelines.
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 |
|---|---|---|
| MouthwashAntiplaque/Antigingivitis Mouthwash | Drug | Brushing and Rinsing A, Brushing and Rinsing B, Brushing and Rinsing C |
| FlossDental Floss | Device | Brushing and Flossing |
| ToothbrushSoft bristled, manual toothbrush | Device | Brushing, Brushing and Flossing, Brushing and Rinsing A, Brushing and Rinsing B, Brushing and Rinsing C |
| ToothpasteSodium Monofluorophosphate 0.76 % (0.15% w/v fluoride ion) toothpaste | Drug | Brushing, Brushing and Flossing, Brushing and Rinsing A, Brushing and Rinsing B, Brushing and Rinsing C |
Primary outcome
Interproximal mean Modified Gingival Index (MGI)
Time frame: 12 weeks
MGI will be visually assessed for six sites for each graded tooth (mesiofacial, facial, distofacial, mesiolingual, lingual, distolingual). Interproximal MGI includes the mesiofacial, distofacial, mesiolingual, and distolingual sites. Higher scores indicate a worse outcome, per below. 0 = no inflammation; no redness 1. = mild inflammation; slight changes in color and texture, but not in all portions of gingival marginal or papillary 2. = mild inflammation; slight changes in color and texture in all portions of gingival margin or papillary 3. = moderate inflammation; bright surface inflammation, erythema, edema, and/or hypertrophy of gingival marginal or papillary 4. = severe inflammation; erythema, edema, and/or marginal gingival hypertrophy of the unit or spontaneous bleeding, papillary, congestion, or ulceration
9 secondary outcomes
Whole Mouth mean Modified Gingival Index (MGI)
Time frame: 1, 4, and 12 weeks
Interproximal mean Turesky Modification of the Quigley-Hein Plaque Index (TPI)
Time frame: 1, 4, and 12 weeks
Whole Mouth mean Turesky Modification of the Quigley-Hein Plaque Index (TPI)
Time frame: 1, 4, and 12 weeks
Interproximal mean Expanded Bleeding Index (EBI)
Time frame: 1, 4, and 12 weeks
Whole Mouth Expanded Bleeding Index (EBI)
Time frame: 1, 4, and 12 weeks
Interproximal mean Bleeding on Probing (BOP)
Time frame: 12 weeks
Whole Mouth mean Bleeding on Probing (BOP)
Time frame: 12 weeks
Interproximal mean Probing Depth (PD)
Time frame: 12 weeks
Whole Mouth mean Probing Depth (PD)
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 30 Oct 2025.
- Individual participant dataSharing planned: Yes
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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.
Jeffery Milleman, DDS, MPA principal investigator
Salus Research, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mouthwash, Floss and Toothbrush in people with Dental Plaque and Gingivitis, run by Colgate Palmolive at 1 site in United States.
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 17 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 30 Oct 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 United States. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Interproximal mean Modified Gingival Index (MGI) (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 30 Oct 2025.