Pre-procedural Mouthwash in Reducing Bacteria in Dental Aerosols

June 2, 2020 updated by: Belén Retamal-Valdes, University of Guarulhos

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 66 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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.
Time Frame: During oral prophylaxis procedure.
During oral prophylaxis procedure.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Guarulhos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2015

Primary Completion (Actual)

March 1, 2015

Study Completion (Actual)

April 1, 2015

Study Registration Dates

First Submitted

August 18, 2016

First Submitted That Met QC Criteria

August 18, 2016

First Posted (Estimate)

August 23, 2016

Study Record Updates

Last Update Posted (Actual)

June 4, 2020

Last Update Submitted That Met QC Criteria

June 2, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE: 41244315.4.0000.5506

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

September 2016

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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