Clinical trial NCT02875769: Pre-procedural Mouthwash in Reducing Bacteria in Dental Aerosols
Official title: Effectiveness of a Pre-procedural Mouthwash in Reducing Bacteria in Dental Aerosols and Splatters: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Periodontitis
Keywords: cetylpyridinium chloride
chlorhexidine
oral aerosol
oral splatter
mouthwash
microbiology
Lead sponsor: University of Guarulhos
Sponsor class: OTHER
First posted: 2016-08-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The aim of this randomized, single blinded clinical trial was to evaluate the effect of a pre-procedural mouthwash containing cetylpyridinium chloride (CPC), zinc lactate (Zn) and sodium fluoride (F) in the reduction of viable bacteria in oral aerosol/splatter after a dental prophylaxis with ultrasonic scaler.

Detailed description: The propagation of oral microorganisms in the dental office during different oral procedures has been a concern. The use of certain equipment such as ultrasonic devices, highspeed dental handpieces or three-way syringes may spread aerosols and splatters containing microorganisms in the environment. These microorganisms may cause cross-infections in the dental office, jeopardizing the health of patients and dental professionals. Different procedures, materials and antimicrobial agents have been proposed to minimize microbial cross-contamination in the dental office. Chlorhexidine (CHX) is considered the gold standard substance in controlling oral biofilm growth in the oral cavity or microbial spread by oral aerosols due to its broad antibacterial spectrum and substantivity of 8 to 12 hours. However, other antiseptics have also been used as pre-procedural mouthwashes. CPC has an important antimicrobial activity and is considered a safe product for marketing. In this context, the present trend has been to combine more than one active substance in mouthwash and toothpaste formulations with the aim of increasing the efficacy of the products, or treating more than one clinical problem, such as plaque accumulation and halitosis, caries or gingival inflammation. Therefore, the aim of this randomized clinical trial (RCT) was to evaluate the effectiveness of a new mouthwash formulation containing 0.075% CPC, 0.28% zinc lactate and 0.05% sodium fluoride (CPC+Zn+F) in reducing viable bacteria present in oral aerosol/splatter. Sixty systemically healthy volunteers receiving dental prophylaxis were randomly assigned to one of the following experimental groups (15 per group): i) rinsing with 0.075% CPC, 0.28% Zn and 0.05% F (CPC+Zn+F), ii) 0.12% chlorhexidine digluconate (CHX), iii) no rinsing and iv) rinsing with water. Viable bacteria were collected from different locations in the dental office on enriched TSA plates and anaerobically incubated for 72 hours. The colonies were counted and species were then identified by Checkerboard DNA-DNA Hybridization. The total number of colony-forming units (CFUs) detected in the aerosols/splatters from volunteers who rinsed with CPC+Zn+F or CHX was statistically significantly (p\<0.05) lower than of those subjects who did not rinse or who rinsed with water. When all locations were considered together, the aerosols/splatters from the CPC+Zn+F and CHX groups showed, respectively, 70% and 77% fewer CFUs than those from the no rinsing group and 61% and 70% than those from the water group. The mean proportions of bacterial species from the orange complex were statistically significantly (p\<0.05) lower in aerosols/splatter from the CPC+Zn+F and CHX groups compared with the two negative controls. In conclusion, the results of the present investigation showed that a mouthwash containing 0.075% CPC, 0.28% Zn and 0.05% F, is effective in reducing viable bacteria in oral aerosol/splatter after a dental prophylaxis with ultrasonic scaler. This finding is highly relevant to the clinical practice, as it may greatly reduce the risk of cross-contamination in dental offices.

Eligibility criteria: Inclusion Criteria:

* aged between 18-70 years;
* minimum of 20 natural teeth (excluding third molars and teeth with advanced decay indicated for extraction);
* at least 80% of the sites with visible supragingival plaque;
* fewer than 10% of sites with visible supragingival calculus;
* fewer than 30% of sites with probing depth (PD) ≥ 5 mm.

Exclusion Criteria:

* presence of orthodontic bands;
* partial removable dentures;
* lesions of the soft or hard tissues of the oral cavity;
* carious lesions requiring immediate restorative treatment;
* history of allergy to CHX, CPC, zinc lactate or sodium fluoride;
* participation in any other clinical study within the one-month period prior to entering into the study;
* professional tooth cleaning procedure (oral prophylaxis) during the period of one month prior to entering the study;
* pregnant or breast-feeding women;
* antibiotic therapy in the previous 6 months;
* continuous use of oral mouthwashes;
* any systemic condition that may require prophylactic medication for dental treatment (e.g., mitral valve prolapse).

Primary outcomes:
measure: Difference between groups (test, positive control, negative control A and negative control B) for the mean number of total colony-forming units (CFUs) in all plates.
timeFrame: During oral prophylaxis procedure.
Secondary outcomes:
measure: Number of total CFUs in plates positioned on the clinician forehead.
timeFrame: During oral prophylaxis procedure.
measure: Number of total CFUs in plates positioned on the volunteer's chest.
timeFrame: During oral prophylaxis procedure.
measure: Number of total CFUs in plates positioned on the support board.
timeFrame: During oral prophylaxis procedure.
measure: Proportion of the microbial complexes.
timeFrame: During oral prophylaxis procedure.
measure: Reduction in CFUs in the CPC+Zn+F and CHX groups in comparison with the two negative control groups.
timeFrame: During oral prophylaxis procedure.
Other outcomes:
Locations:
Study officials:
affiliation: Guarulhos University
name: Magda Feres, Professor
role: STUDY_CHAIR
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