Pre-procedural Mouthwash in Reducing Bacteria in Dental Aerosols
NCT ID: NCT02875769
Last Updated: 2020-06-04
Study Results
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Basic Information
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COMPLETED
PHASE3
60 participants
INTERVENTIONAL
2015-02-28
2015-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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.
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.
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.
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.
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.
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.
Negative control A: No rinsing
No rinsing with pre-procedural mouthwash + full mouth dental prophylaxis using ultrasonic scaler.
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.
No rinsing
The volunteer did not rinse with any pre-procedural mothwash.
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.
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.
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.
Interventions
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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.
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.
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.
No rinsing
The volunteer did not rinse with any pre-procedural mothwash.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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).
18 Years
70 Years
ALL
No
Sponsors
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University of Guarulhos
OTHER
Responsible Party
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Belén Retamal-Valdes
DDS, MSc, PhD Student
Principal Investigators
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Magda Feres, Professor
Role: STUDY_CHAIR
Guarulhos University
References
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Provided Documents
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Document Type: Statistical Analysis Plan
Other Identifiers
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CAAE: 41244315.4.0000.5506
Identifier Type: -
Identifier Source: org_study_id
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