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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial summary

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

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.

Show all 13Show fewer

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.

Luciene C Figueiredo, PhD contact

+5511982945577

luciene.figueiredo@prof.ung.br

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 groups in NCT07880509
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.

8 Oct 202623 Dec 2026

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.
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)

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.