Pre-procedural Mouthwash in Reducing Bacteria in Dental Aerosols

NCT02875769 | Completed Phase 3

• 1 other identifier: CAAE: 41244315.4.0000.5506
• Study Type: interventional
• Target: 60
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Periodontitis

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• 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.

Study Arms (4)

Test: Mouthwash CPC+Zn+F

EXPERIMENTAL

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; Drug: Mouthwash CPC+Zn+F

Positive control: Mouthwash CHX

ACTIVE COMPARATOR

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; Drug: Mouthwash CHX

Negative control A: No rinsing

PLACEBO COMPARATOR

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

Procedure: Dental prophylaxis; Other: No rinsing

Negative control B: Water

PLACEBO COMPARATOR

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; Other: Water

Interventions

Dental prophylaxis PROCEDURE

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.

Negative control A: No rinsing; Negative control B: Water; Positive control: Mouthwash CHX; Test: Mouthwash CPC+Zn+F

Mouthwash CPC+Zn+F DRUG

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.

Also known as: Pre-procedural mouthwash CPC+Zn+F

Test: Mouthwash CPC+Zn+F

Mouthwash CHX DRUG

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.

Also known as: Pre-procedural mouthwash

Positive control: Mouthwash CHX

No rinsing OTHER

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

Negative control A: No rinsing

Water OTHER

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.

Negative control B: Water

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Guarulhos: lead

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MeSH Terms

Conditions

Chronic Periodontitis

Interventions

Dental Prophylaxis; Water

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Periodontics; Dentistry; Preventive Dentistry; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds

Study Officials

• Magda Feres, Professor

  Guarulhos University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: DDS, MSc, PhD Student

Study Record Dates

• First Submitted: August 18, 2016
• First Posted: August 23, 2016
• Study Start: February 1, 2015
• Primary Completion: March 1, 2015
• Study Completion: April 1, 2015
• Last Updated: June 4, 2020

Record last verified: 2020-06

Data Sharing

• IPD Sharing: Will share