A Phase 4 interventional study of 0.09% CPC + Zinc Lactate Mouthwash and 0.2% Chlorhexidine Mouthwash in Bacterial Contamination, sponsored by Colgate Palmolive. Not yet recruiting. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Colgate Palmolive · Phase 4, Interventional, and Prevention
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.
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:
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
Colgate Palmolive is the lead sponsor of 118 studies on the registry; 13 are open to participants now.
Of its 35 completed or terminated interventional studies of FDA-regulated products, 2 (6%) have results posted.
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Exclusion Criteria:
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.
Drug: 0.09% CPC + Zinc Lactate Mouthwash
Participants rinse for 60 seconds (1 minute) with 10 mL of commercially available 0.2% Chlorhexidine mouthwash prior to dental prophylaxis.
Drug: 0.2% Chlorhexidine Mouthwash
Participants rinse for 30 seconds with 20 mL of site water dispensed from the dental chair triple syringe prior to dental prophylaxis.
Other: Water
Standard of care with no pre-procedural rinsing procedures performed prior to dental prophylaxis.
Alcohol-free mouthwash containing 0.09% Cetylpyridinium Chloride and Zinc Lactate with fluoride.
Commercially available 0.2% Chlorhexidine mouthwash.
Water dispensed directly from the dental chair triple syringe.
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.
Time frame: Day 1 (at 10 minutes into prophylaxis and 15 minutes post-prophylaxis)
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.
Time frame: 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.
Time frame: 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.
Time frame: Day 1 (at 10 minutes into prophylaxis and 15 minutes post-prophylaxis)
No study locations are listed for this record.
Plan to share: No — Individual participant data will not be shared to protect participant privacy as outlined in the study consent and privacy notice.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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