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Pre-procedural Mouthwash in Reducing Bacteria in Dental Aerosols

Primary Purpose

Chronic Periodontitis

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Dental prophylaxis

Mouthwash CPC+Zn+F

Mouthwash CHX

No rinsing

Water

About this trial

This is an interventional prevention trial for Chronic Periodontitis focused on measuring cetylpyridinium chloride, chlorhexidine, oral aerosol, oral splatter, mouthwash, microbiology

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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).

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Test: Mouthwash CPC+Zn+F

Positive control: Mouthwash CHX

Negative control A: No rinsing

Negative control B: Water

Arm Description

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.

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.

No rinsing with pre-procedural mouthwash + full mouth dental prophylaxis using ultrasonic scaler.

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.

Outcomes

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.

Secondary Outcome Measures

Number of total CFUs in plates positioned on the clinician forehead.

Number of total CFUs in plates positioned on the volunteer's chest.

Number of total CFUs in plates positioned on the support board.

Proportion of the microbial complexes.

Reduction in CFUs in the CPC+Zn+F and CHX groups in comparison with the two negative control groups.

Full Information

NCT ID

NCT02875769

First Posted

August 18, 2016

Last Updated

June 2, 2020

Sponsor

University of Guarulhos

1. Study Identification

Unique Protocol Identification Number

NCT02875769

Brief Title

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

2. Study Status

Record Verification Date

June 2020

Overall Recruitment Status

Completed

Study Start Date

February 2015 (undefined)

Primary Completion Date

March 2015 (Actual)

Study Completion Date

April 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Guarulhos

4. Oversight

Data Monitoring Committee

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Periodontitis

Keywords

cetylpyridinium chloride, chlorhexidine, oral aerosol, oral splatter, mouthwash, microbiology

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

Care Provider

Allocation

Randomized

Enrollment

60 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Test: Mouthwash CPC+Zn+F

Arm Type

Experimental

Arm Description

Arm Title

Positive control: Mouthwash CHX

Arm Type

Active Comparator

Arm Description

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.

Arm Title

Negative control A: No rinsing

Arm Type

Placebo Comparator

Arm Description

No rinsing with pre-procedural mouthwash + full mouth dental prophylaxis using ultrasonic scaler.

Arm Title

Negative control B: Water

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Procedure

Intervention Name(s)

Dental prophylaxis

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Mouthwash CPC+Zn+F

Other Intervention Name(s)

Pre-procedural mouthwash CPC+Zn+F

Intervention Description

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.

Intervention Type

Drug

Intervention Name(s)

Mouthwash CHX

Other Intervention Name(s)

Pre-procedural mouthwash

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

No rinsing

Intervention Description

The volunteer did not rinse with any pre-procedural mothwash.

Intervention Type

Other

Intervention Name(s)

Water

Intervention Description

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.

Primary Outcome Measure Information:

Title

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