Pre-procedural Mouthwash in Reducing Bacteria in Dental Aerosols

Sponsor

University of Guarulhos (Other)

Overall Status

Completed

CT.gov ID

NCT02875769

Collaborator

(none)

Enrollment

Arms

1.9

Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Periodontitis	Procedure: Dental prophylaxis Drug: Mouthwash CPC+Zn+F Drug: Mouthwash CHX Other: No rinsing Other: Water	Phase 3

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Care Provider)

Primary Purpose:

Prevention

Official Title:

Effectiveness of a Pre-procedural Mouthwash in Reducing Bacteria in Dental Aerosols and Splatters: a Randomized Clinical Trial

Study Start Date :

Feb 1, 2015

Actual Primary Completion Date :

Mar 1, 2015

Actual Study Completion Date :

Apr 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test: Mouthwash CPC+Zn+F To rinse with pre-procedural mouthwash containing 0.075% cetylpyridinium chloride, 0.28% zinc lactate and 0.05% sodium fluoride in an Alcohol-free base (for one minute and 20 ml of solution) + full mouth dental prophylaxis using ultrasonic scaler.	Procedure: Dental prophylaxis Full mouth dental prophylaxis (FMDP) was conducted in one appointment lasting 10 minute, using an ultrasonic scaler at a frequency of 25 kHz (Cavitron Select SPC, Dentsply professional, York, PA, USA) at less than 50% power. The FMDP performed without anesthesia and in order to eliminate supragingival plaque, calculus and stainings. Drug: Mouthwash CPC+Zn+F The volunteer rinsed with pre-procedural mouthwash containing 0.075% cetylpyridinium chloride, 0.28% zinc lactate and 0.05% sodium fluoride in an Alcohol-free base for one minute, 20 ml of solution and then expectorated all remaining liquid. Other Names: Pre-procedural mouthwash CPC+Zn+F
Active Comparator: Positive control: Mouthwash CHX To rinse with pre-procedural mouthwash containing 0.12% CHX with 10% alcohol (for one minute and 20 ml of solution) + full mouth dental prophylaxis using ultrasonic scaler.	Procedure: Dental prophylaxis Full mouth dental prophylaxis (FMDP) was conducted in one appointment lasting 10 minute, using an ultrasonic scaler at a frequency of 25 kHz (Cavitron Select SPC, Dentsply professional, York, PA, USA) at less than 50% power. The FMDP performed without anesthesia and in order to eliminate supragingival plaque, calculus and stainings. Drug: Mouthwash CHX The volunteer rinsed with pre-procedural mouthwash containing 0.12% CHX with 10% alcohol for one minute, 20 ml of solution and then expectorated all remaining liquid. Other Names: Pre-procedural mouthwash
Placebo Comparator: Negative control A: No rinsing No rinsing with pre-procedural mouthwash + full mouth dental prophylaxis using ultrasonic scaler.	Procedure: Dental prophylaxis Full mouth dental prophylaxis (FMDP) was conducted in one appointment lasting 10 minute, using an ultrasonic scaler at a frequency of 25 kHz (Cavitron Select SPC, Dentsply professional, York, PA, USA) at less than 50% power. The FMDP performed without anesthesia and in order to eliminate supragingival plaque, calculus and stainings. Other: No rinsing The volunteer did not rinse with any pre-procedural mothwash.
Placebo Comparator: Negative control B: Water To rinse with pre-procedural mouthwash containing water from a three-way syringe (for one minute and 20 ml of solution) + full mouth dental prophylaxis using ultrasonic scaler.	Procedure: Dental prophylaxis Full mouth dental prophylaxis (FMDP) was conducted in one appointment lasting 10 minute, using an ultrasonic scaler at a frequency of 25 kHz (Cavitron Select SPC, Dentsply professional, York, PA, USA) at less than 50% power. The FMDP performed without anesthesia and in order to eliminate supragingival plaque, calculus and stainings. Other: Water The volunteer rinsed with pre-procedural mouthwash containing water from a three-way syringe for one minute, 20 ml of water and then expectorated all remaining liquid.

Outcome Measures

Primary Outcome Measures

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. [During oral prophylaxis procedure.]

Secondary Outcome Measures

Number of total CFUs in plates positioned on the clinician forehead. [During oral prophylaxis procedure.]
Number of total CFUs in plates positioned on the volunteer's chest. [During oral prophylaxis procedure.]
Number of total CFUs in plates positioned on the support board. [During oral prophylaxis procedure.]
Proportion of the microbial complexes. [During oral prophylaxis procedure.]
Reduction in CFUs in the CPC+Zn+F and CHX groups in comparison with the two negative control groups. [During oral prophylaxis procedure.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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).