Bacterial Contamination
Conditions
Keywords
Cetylpyridinium Chloride, Zinc Lactate, Chlorhexidine, Pre-procedural Rinse, Ultrasonic Prophylaxis
Brief 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 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: 1. 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. 2. Rinsing Stage: Participants perform their assigned pre-procedural rinse. 3. Post-Rinse Collection: Immediate post-rinse passive saliva sample (2 mL) is collected. 4. 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. 5. Mid-Procedure Collection: At the 10-minute mark of scaling, the first set of agar plates is sealed. Full-mouth scaling continues until complete. 6. 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
Interventions
DRUG0.09% CPC + Zinc Lactate Mouthwash
Alcohol-free mouthwash containing 0.09% Cetylpyridinium Chloride and Zinc Lactate with fluoride.
Commercially available 0.2% Chlorhexidine mouthwash.
OTHERWater
Water dispensed directly from the dental chair triple syringe.
Sponsors
Colgate Palmolive
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Masking description
An unblinded study coordinator dispenses assigned products in blinded containers. Dental examiners, participants, and laboratory technicians performing CFU counts and DNA hybridization remain fully blinded throughout.
Intervention model description
Single-center, prospective, double-blind, randomized, 4-arm parallel-group clinical trial.
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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. * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Viable Bacterial Colony-Forming Units (CFUs) in Dental Aerosols | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Aerosol Dispersal Colony-Forming Units (CFUs) by Location | Day 1 (at 10 minutes into prophylaxis and 15 minutes post-prophylaxis) | Difference in mean CFU counts across specific aerosol sampling sites: clinician forehead, patient chest, and dental light reflector. |
| Change in Salivary Bacterial Load | Baseline (pre-rinse), immediately post-rinse, and 15 minutes post-prophylaxis on Day 1 | Mean absolute change and percentage change in salivary bacterial counts (Log CFU/mL) from baseline. |
| Proportional Shifts in Oral Microbial Species | Day 1 (at 10 minutes into prophylaxis and 15 minutes post-prophylaxis) | Proportional shifts in 40 targeted oral bacterial species analyzed via Checkerboard DNA-DNA Hybridization. |
Contacts
CONTACTLuciene C Figueiredo, PhD
Outcome results
None listed