A Phase 3 interventional study of Dental prophylaxis and Mouthwash CPC+Zn+F in Chronic Periodontitis, sponsored by University of Guarulhos. Completed. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-06-04.
Sponsored by University of Guarulhos · Phase 3, Interventional, and Prevention
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.
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.
1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.
This study's enrollment of 60 is above the median of 45 across 1,191 interventional studies indexed under Periodontitis.
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Exclusion Criteria:
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
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
No rinsing with pre-procedural mouthwash + full mouth dental prophylaxis using ultrasonic scaler.
Procedure: Dental prophylaxis · Other: No rinsing
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
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.
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
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
The volunteer did not rinse with any pre-procedural mothwash.
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.
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.
Number of total CFUs in plates positioned on the clinician forehead.
Time frame: During oral prophylaxis procedure.
Number of total CFUs in plates positioned on the volunteer's chest.
Time frame: During oral prophylaxis procedure.
Number of total CFUs in plates positioned on the support board.
Time frame: During oral prophylaxis procedure.
Proportion of the microbial complexes.
Time frame: 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.
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Plan to share: Yes — September 2016
This study is completed, as verified in Jun 2020. You cannot join it, but the record below documents what was studied.
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University of Guarulhos