Bacterial ContaminationPhase 4NCT07880509
Effectiveness of Pre-Procedural CPC and Zinc Mouthwash in Reducing Dental Aerosols
A Phase 4 study testing 0.09% CPC + Zinc Lactate Mouthwash, 0.2% Chlorhexidine Mouthwash and Water in people with Bacterial Contamination, run by Colgate Palmolive.
Trial summary
This clinical trial evaluates the effectiveness of pre-procedural mouthwashes in reducing bacterial contamination in dental aerosols generated during ultrasonic scaling. Participants undergo a single-day clinical visit where they receive a randomized pre-procedural rinse (or control) followed by full-mouth ultrasonic… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Bacterial Contamination
- What is being tested?
- 0.09% CPC + Zinc Lactate Mouthwash, 0.2% Chlorhexidine Mouthwash and Water
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 8 Oct 2026to 23 Dec 2026
- Phase
- Phase 4
- 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
- Males and females between 18 and 70 years of age, inclusive.
- Availability for the full duration of the study visit.
- Good general health without conditions posing risk during dental procedures.
- Willingness to provide medical history and sign Informed Consent and Privacy Notice forms.
- Minimum of 20 uncrowned permanent natural teeth (excluding third molars and artificial crowns).
- At least 80% of tooth sites with visible supragingival plaque.
- Less than 10% of tooth sites with visible supragingival calculus.
- Less than 30% of tooth sites with pocket depth (PD) and clinical attachment level (CAL) > 5 mm.
Who cannot join
- Presence of gross oral mucosal pathology.
- Uncontrolled systemic chronic disease (e.g., uncontrolled diabetes) or conditions interfering with host immune response.
- Use of anti-inflammatory drugs or antibiotics within 3 months prior to study start, or scheduled use during study.
- Use of therapeutic mouthwashes within 3 months prior to study start.
- Requirement for antibiotic prophylaxis prior to dental procedures.
- Current participation in any other clinical study.
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- Pregnant, breastfeeding, or intending to become pregnant during the study.
- Known allergy to oral care products, personal care consumer products, or their ingredients.
- Ongoing use of medications known to affect gingival tissues (e.g., calcium channel blockers, phenytoin, cyclosporine).
- Current smokers or history of alcohol or substance abuse.
- Presence of orthodontic appliances or fixed/removable prosthodontic dentures.
- Presence of carious lesions requiring immediate restorative treatment.
- Professional dental cleaning (oral prophylaxis) within 1 month prior to study enrollment.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Clinical Study to Assess the Effectiveness of Pre-Procedural Rinsing With a Mouthwash Containing Cetylpyridinium Chloride and Zinc Lactate in Reducing Viable Bacteria in Dental Aerosols
This clinical trial evaluates the effectiveness of pre-procedural mouthwashes in reducing bacterial contamination in dental aerosols generated during ultrasonic scaling. Participants undergo a single-day clinical visit where they receive a randomized pre-procedural rinse (or control) followed by full-mouth ultrasonic prophylaxis. Viable bacteria in aerosols collected on agar plates surrounding the dental unit are measured to determine whether rinsing with an alcohol-free mouthwash containing 0.09% Cetylpyridinium Chloride (CPC) and 0.28% Zinc Lactate significantly lowers bacterial contamination compared to water, no rinse, or a 0.2% Chlorhexidine positive control.
Read the detailed description
Aerosols generated during dental procedures such as ultrasonic scaling contain viable microorganisms from saliva and dental plaque, posing potential contamination risks in dental clinics. This single-center, Phase IV, double-blind, randomized, 4-arm parallel clinical study assesses the efficacy of pre-procedural mouthrinsing in reducing viable bacterial counts in aerosols and saliva. Sixty adult participants meeting eligibility criteria are randomized into 1 of 4 treatment groups (1:1:1:1 ratio): Test Group (0.09% CPC + 0.28% Zinc Lactate mouthwash, 20 mL for 30 sec), Positive Control (0.2% Chlorhexidine mouthwash, 10 mL for 60 sec), Negative Control I (dental chair water, 20 mL for 30 sec), or Negative Control II (no rinse).
Sequence of study procedures:
- Baseline Collection: Passive baseline saliva sample (2 mL) is collected after a 12-hour oral hygiene restriction and 4-hour food/drink fasting period. Ambient air baseline is verified via blood agar plates.
- Rinsing Stage: Participants perform their assigned pre-procedural rinse.
- Post-Rinse Collection: Immediate post-rinse passive saliva sample (2 mL) is collected.
- Prophylaxis \& Aerosol Sampling: Blood agar plates are placed at designated locations (6 on dental light reflector, 2 on patient chest, 2 on clinician forehead). Ultrasonic scaling commences using a 25 kHz scaler.
- Mid-Procedure Collection: At the 10-minute mark of scaling, the first set of agar plates is sealed. Full-mouth scaling continues until complete.
- Post-Prophylaxis Settle \& Final Collection: A 15-minute settling period follows, after which remaining agar plates are sealed and a final saliva sample (2 mL) is collected.
Microbiological Analysis: Blood agar plates are incubated anaerobically (37°C, 72 hours) and colony-forming units (CFUs) are counted. DNA hybridization (Checkerboard technique) identifies and quantifies 40 target oral bacterial species
- Conditions
- Bacterial Contamination
- Being tested
- 0.09% CPC + Zinc Lactate Mouthwash, 0.2% Chlorhexidine Mouthwash, Water
- Keywords
- Cetylpyridinium Chloride, Zinc Lactate, Chlorhexidine, Pre-procedural Rinse, Ultrasonic Prophylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
0.09% CPC + Zinc Lactate MouthwashDrug
Alcohol-free mouthwash containing 0.09% Cetylpyridinium Chloride and Zinc Lactate with fluoride.
0.2% Chlorhexidine MouthwashDrug
Commercially available 0.2% Chlorhexidine mouthwash.
WaterOther
Water dispensed directly from the dental chair triple syringe.
| Study group | Role | What they receive |
|---|---|---|
| Test Group (CPC + Zinc) | Experimental | Participants rinse for 30 seconds with 20 mL of an alcohol-free mouthwash containing 0.09% Cetylpyridinium Chloride (CPC) and Zinc Lactate prior to dental prophylaxis. Receives: Drug: 0.09% CPC + Zinc Lactate Mouthwash |
| Positive Control Group (0.2% CHX) | Active comparator | Participants rinse for 60 seconds (1 minute) with 10 mL of commercially available 0.2% Chlorhexidine mouthwash prior to dental prophylaxis. Receives: Drug: 0.2% Chlorhexidine Mouthwash |
| Negative Control Group I (Water) | Placebo comparator | Participants rinse for 30 seconds with 20 mL of site water dispensed from the dental chair triple syringe prior to dental prophylaxis. Receives: Other: Water |
| Negative Control Group II (Standard of Care) | No intervention | Standard of care with no pre-procedural rinsing procedures performed prior to dental prophylaxis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Viable Bacterial Colony-Forming Units (CFUs) in Dental Aerosols
Mean number of total viable bacterial colony-forming units (CFUs) across all blood agar plates and sampling locations combined.
Measured: Day 1 (at 10 minutes into prophylaxis and 15 minutes post-prophylaxis)
Secondary outcomes (3)
Aerosol Dispersal Colony-Forming Units (CFUs) by Location
Difference in mean CFU counts across specific aerosol sampling sites: clinician forehead, patient chest, and dental light reflector.
Measured: Day 1 (at 10 minutes into prophylaxis and 15 minutes post-prophylaxis)
Change in Salivary Bacterial Load
Mean absolute change and percentage change in salivary bacterial counts (Log CFU/mL) from baseline.
Measured: Baseline (pre-rinse), immediately post-rinse, and 15 minutes post-prophylaxis on Day 1
Proportional Shifts in Oral Microbial Species
Proportional shifts in 40 targeted oral bacterial species analyzed via Checkerboard DNA-DNA Hybridization.
Measured: Day 1 (at 10 minutes into prophylaxis and 15 minutes post-prophylaxis)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2026
- Study start8 Oct 2026 (estimated)
- Primary completion15 Dec 2026 (estimated)
- Study completion23 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bacterial ContaminationStudies 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
- Model description
- Single-center, prospective, double-blind, randomized, 4-arm parallel-group clinical trial.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Colgate Palmolive
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07880509
- Sponsor's protocol ID
- CRO-2026-07-PRE-PRO-BR-CB
- Status last verified
- Oct 2026
- First submitted
- 7 Oct 2026
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared to protect participant privacy as outlined in the study consent and privacy notice.
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Assess the Effectiveness of Pre-Procedural Rinsing With a Mouthwash Containing Cetylpyridinium Chloride and Zinc Lactate in Reducing Viable Bacteria in Dental Aerosols
- ClinicalTrials.gov ID
- NCT07880509
- Acronym / sponsor ID
- CRO-2026-07-PRE-PRO-BR-CB
- Conditions
- Bacterial Contamination
- Keywords
- Cetylpyridinium Chloride, Zinc Lactate, Chlorhexidine, Pre-procedural Rinse, Ultrasonic Prophylaxis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Colgate PalmoliveIndustry (pharma, biotech, devices)
- Study start
- 8 Oct 2026 (estimated)
- Primary completion
- 15 Dec 2026 (estimated)
- Study completion
- 23 Dec 2026 (estimated)
- First posted
- 19 Oct 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.
This clinical trial evaluates the effectiveness of pre-procedural mouthwashes in reducing bacterial contamination in dental aerosols generated during ultrasonic scaling. Participants undergo a single-day clinical visit where they receive a randomized pre-procedural rinse (or control) followed by full-mouth ultrasonic prophylaxis. Viable bacteria in aerosols collected on agar plates surrounding the dental unit are measured to determine whether rinsing with an alcohol-free mouthwash containing 0.09% Cetylpyridinium Chloride (CPC) and 0.28% Zinc Lactate significantly lowers bacterial contamination compared to water, no rinse, or a 0.2% Chlorhexidine positive control.
Detailed description
Aerosols generated during dental procedures such as ultrasonic scaling contain viable microorganisms from saliva and dental plaque, posing potential contamination risks in dental clinics. This single-center, Phase IV, double-blind, randomized, 4-arm parallel clinical study assesses the efficacy of pre-procedural mouthrinsing in reducing viable bacterial counts in aerosols and saliva. Sixty adult participants meeting eligibility criteria are randomized into 1 of 4 treatment groups (1:1:1:1 ratio): Test Group (0.09% CPC + 0.28% Zinc Lactate mouthwash, 20 mL for 30 sec), Positive Control (0.2% Chlorhexidine mouthwash, 10 mL for 60 sec), Negative Control I (dental chair water, 20 mL for 30 sec), or Negative Control II (no rinse).
Sequence of study procedures:
- Baseline Collection: Passive baseline saliva sample (2 mL) is collected after a 12-hour oral hygiene restriction and 4-hour food/drink fasting period. Ambient air baseline is verified via blood agar plates.
- Rinsing Stage: Participants perform their assigned pre-procedural rinse.
- Post-Rinse Collection: Immediate post-rinse passive saliva sample (2 mL) is collected.
- Prophylaxis \& Aerosol Sampling: Blood agar plates are placed at designated locations (6 on dental light reflector, 2 on patient chest, 2 on clinician forehead). Ultrasonic scaling commences using a 25 kHz scaler.
- Mid-Procedure Collection: At the 10-minute mark of scaling, the first set of agar plates is sealed. Full-mouth scaling continues until complete.
- Post-Prophylaxis Settle \& Final Collection: A 15-minute settling period follows, after which remaining agar plates are sealed and a final saliva sample (2 mL) is collected.
Microbiological Analysis: Blood agar plates are incubated anaerobically (37°C, 72 hours) and colony-forming units (CFUs) are counted. DNA hybridization (Checkerboard technique) identifies and quantifies 40 target oral bacterial species
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- Single-center, prospective, double-blind, randomized, 4-arm parallel-group clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Test Group (CPC + Zinc) | Experimental | Drug: 0.09% CPC + Zinc Lactate MouthwashParticipants rinse for 30 seconds with 20 mL of an alcohol-free mouthwash containing 0.09% Cetylpyridinium Chloride (CPC) and Zinc Lactate prior to dental prophylaxis. |
| Positive Control Group (0.2% CHX) | Active comparator | Drug: 0.2% Chlorhexidine MouthwashParticipants rinse for 60 seconds (1 minute) with 10 mL of commercially available 0.2% Chlorhexidine mouthwash prior to dental prophylaxis. |
| Negative Control Group I (Water) | Placebo comparator | Other: WaterParticipants rinse for 30 seconds with 20 mL of site water dispensed from the dental chair triple syringe prior to dental prophylaxis. |
| Negative Control Group II (Standard of Care) | No intervention | –Standard of care with no pre-procedural rinsing procedures performed prior to dental prophylaxis. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Males and females between 18 and 70 years of age, inclusive.
- Availability for the full duration of the study visit.
- Good general health without conditions posing risk during dental procedures.
- Willingness to provide medical history and sign Informed Consent and Privacy Notice forms.
- Minimum of 20 uncrowned permanent natural teeth (excluding third molars and artificial crowns).
Key exclusion criteria (13 listed)
- Presence of gross oral mucosal pathology.
- Uncontrolled systemic chronic disease (e.g., uncontrolled diabetes) or conditions interfering with host immune response.
- Use of anti-inflammatory drugs or antibiotics within 3 months prior to study start, or scheduled use during study.
- Use of therapeutic mouthwashes within 3 months prior to study start.
- Requirement for antibiotic prophylaxis prior to dental procedures.
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 |
|---|---|---|
| 0.09% CPC + Zinc Lactate MouthwashAlcohol-free mouthwash containing 0.09% Cetylpyridinium Chloride and Zinc Lactate with fluoride. | Drug | Test Group (CPC + Zinc) |
| 0.2% Chlorhexidine MouthwashCommercially available 0.2% Chlorhexidine mouthwash. | Drug | Positive Control Group (0.2% CHX) |
| WaterWater dispensed directly from the dental chair triple syringe. | Other | Negative Control Group I (Water) |
Primary outcome
Total Viable Bacterial Colony-Forming Units (CFUs) in Dental Aerosols
Time frame: Day 1 (at 10 minutes into prophylaxis and 15 minutes post-prophylaxis)
Mean number of total viable bacterial colony-forming units (CFUs) across all blood agar plates and sampling locations combined.
3 secondary outcomes
Aerosol Dispersal Colony-Forming Units (CFUs) by Location
Time frame: Day 1 (at 10 minutes into prophylaxis and 15 minutes post-prophylaxis)
Change in Salivary Bacterial Load
Time frame: Baseline (pre-rinse), immediately post-rinse, and 15 minutes post-prophylaxis on Day 1
Proportional Shifts in Oral Microbial Species
Time frame: Day 1 (at 10 minutes into prophylaxis and 15 minutes post-prophylaxis)
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 19 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared to protect participant privacy as outlined in the study consent and privacy notice.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing 0.09% CPC + Zinc Lactate Mouthwash, 0.2% Chlorhexidine Mouthwash and Water in people with Bacterial Contamination, run by Colgate Palmolive.
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 13 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 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
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 Luciene C Figueiredo, PhD (+5511982945577, luciene.figueiredo@prof.ung.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Viable Bacterial Colony-Forming Units (CFUs) in Dental Aerosols (time frame: Day 1 (at 10 minutes into prophylaxis and 15 minutes post-prophylaxis)). 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 19 Oct 2026.