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. 2020 Oct 13;2020(10):CD013686. doi: 10.1002/14651858.CD013686.pub2

Desarda 2014.

Study characteristics
Methods Trial design: RCT – split‐mouth design
Location: Tatyasaheb Kore Dental College and Research Centre, New Pargaon, Kolhapur, Maharashtra, India
Setting: fumigated closed operatory
Language: English
Number of centres: 1
Study period: not mentioned
Funding source: not mentioned
Study protocol: not available
Participants Age: 30 to 60 years
Total number of participants: 80
Inclusion criteria: patients aged 30 to 60 years with chronic generalized periodontitis were selected based on International Workshop for Classification of Periodontal Diseases, 1999 (AAP 1999)
Exclusion criteria: patients with severely debilitating systemic diseases, with pacemakers, with a history of respiratory diseases, a history of previous periodontal treatment for 1‐year period, or on any antibiotics for 6‐month period
Number randomized: 80
Number evaluated: 80 (no missing participants)
Interventions Comparison: HVE versus no HVE
Intervention:
Group name: group Y – presence of high‐volume evacuator
Number of intervention groups: 1
Number randomized to intervention group: not clear ‐ n = 80 assumed
Description of intervention: maxillary incisors and canines were selected as an area for scaling. A piezoelectric scaler (BONARTTM) was used. Scaling was performed in the presence of the high‐volume evacuator in the above‐mentioned area. Power and water flow settings of the scaler were kept the same throughout the procedure. The high‐volume evacuator tip used in this study was stainless steel with a diameter of 12 mm. Nutrient agar plates were exposed for 20 minutes in each group and incubated at 37 °C for 24 hours.
Any co‐interventions: no (but saliva ejector was used in both groups)
Comparator:
Group name: group X ‐ absence of high‐volume evacuator
Number of control groups: 1
Number randomized: not clear ‐ n = 80 assumed
Description of intervention: maxillary incisors and canines were selected as an area for scaling. A piezoelectric scaler (BONARTTM) was used. Scaling was performed in the absence of the high‐volume evacuator in the above‐mentioned area. Power and water flow settings of the scaler were kept the same throughout the procedure.
Outcomes Outcome name: reduction in contamination of aerosols (nutrient agar plates were used to check CFU in 2 areas – 20 inches from participant's mouth and 12 inches from participant's mouth)
Outcome measurement: reduction in contamination of aerosols (difference in number of CFU)
Effect estimate: mean + SD
Key conclusions: "within the limitations of the present study, the results showed no difference in reduction of aerosols with or without the use of a high‐volume evacuator when analyzed microbiologically. Thus, it was concluded that high‐volume evacuator when used as a separate unit without any modification is not effective in reducing aerosol count and environmental contamination".
Notes Study authors contacted for: allocation concealment, blinding of participants and personnel, study protocol and details of statistical tests (authors used Student's t test; for a split‐mouth study, paired t‐test should be used). E‐mail sent on 18 June 2020 but no response received.
Scaling was carried out for 10 minutes in both groups.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Quote: “Coin toss was used to determine which procedure was to be performed first (i.e. with high‐volume evacuator or without high‐volume evacuator)”
Allocation concealment (selection bias) Unclear risk No details given
Blinding of participants and personnel (performance bias)
All outcomes Low risk Blinding is not possible. However, participants and personnel will not be able to alter their behaviour even if they know the received intervention.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Quote: "The next day, the nutrient agar plates were examined for colony forming units by a single microbiologist who was unaware of the procedure performed."
Incomplete outcome data (attrition bias)
All outcomes Low risk No dropouts
Selective reporting (reporting bias) Unclear risk We are not sure of reporting selective outcomes as there is no protocol available.
Other bias Low risk None