Holloman 2015.

Study characteristics
Methods	Trial design: RCT – parallel arm Location: General and Oral Health Center in the School of Dentistry at the University of North Carolina at Chapel Hill, USA Setting: single enclosed dental operatory Language: English Number of centres: 1 Study period: not mentioned Funding source: not mentioned Study protocol: not available
Participants	Age: 18 years or older Total number of participants: 50 (25 per group) Inclusion criteria: Had not received dental scaling, root planing, or prophylaxis in the preceding 3 months Absence of tooth sensitivity that would prevent use of the ultrasonic scaler Willingness to refrain from oral hygiene practices for 12 hours before the appointment Exclusion criteria: Respiratory infection Cardiac pacemaker Chronic disease with oral manifestations Gross oral pathology Currently receiving antibiotic or steroid therapy Active infectious disease such as HIV, tuberculosis, or hepatitis B Number randomized: not reported Number evaluated (withdrawals/missing participants): 50 (no dropouts)
Interventions	Comparison: combination system versus saliva ejector Intervention: Group name: the test device was the Isolite illuminated dental isolation system (test device attaches to high‐volume suction, and is expected to behave similarly to the HVE) Number of intervention groups: 1 Number randomized to intervention group: 25 Description of intervention: study compared the reduction in aerosols and spatter when using the Isolite suction device in the intervention group during ultrasonic scaling in a clinical environment using a 30‐kHz Cavitron Select SPS Ultrasonic Scaler and a Dentsply 30K slimline scaling tip. Quote: "The airflow in the operatory was set to an exchange rate of 6 to 8 times per hour. Each participant was seated in a supine position during the cleaning and was treated by the same clinician. The clinician (J.L.H.) was a licensed dental hygienist with 5 years of clinical experience and 3 years of experience with the test device. Before ultrasonic scaling, a single Petri dish containing the 20 mL of sterile DPBS solution was placed centrally 6 inches from the oral cavity. At the onset of ultrasonic scaling, the lid to the Petri dish was removed for the duration of ultrasonic scaling, and the exposure time was recorded. Immediately after exposure to the ultrasonic scaler, the Petri dish was recapped and replaced with a second Petri dish containing 20 mL of fresh DPBS. The second Petri dish remained open for 35 minutes to collect postexposure aerosols; the operator then recapped it. The remainder of the participants’ prophylaxis proceeded without the use of any devices that would create aerosols or spatter, such as those used in coronal polishing or an air‐powder polisher. To prevent cross‐contamination of aerosols, we scheduled only 1 participant per day." Any co‐interventions: no Comparator: Group name: the positive control was the standard saliva ejector, a disposable attachment to the low‐volume suction hose. Number of control groups: 1 Number randomized to control group: 25 Description of control: same as above except that a standard saliva ejector, a disposable attachment to the low‐volume suction hose was used as the control.
Outcomes	Outcome name: reduction in the level of contamination in aerosols (trial authors call it reduction in aerosols and splatter. But the measurement is done using CFU) Outcome measurement: CFU/ml Effect estimate: mean log10 (SD) Key conclusions: practical implications of this study suggest that neither the Isolite device nor the saliva ejector effectively reduced aerosols and spatter during ultrasonic scaling
Notes	Study authors were contacted for: allocation concealment, blinding, number randomised and study protocol. E‐mail sent on 26 July 2020 and we are yet to receive any response from the contact author.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Quote: “Participants were randomized with the flip of a coin into 1 of 2 treatment groups”
Allocation concealment (selection bias)	Unclear risk	No details available
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	Assessor blinded. Quote: "After incubation, the principal investigator counted the Brucella agar plates by hand and recorded the results. Each sample was marked with a number so that the investigator was masked as to the device used for each sample when recording CFUs."
Incomplete outcome data (attrition bias) All outcomes	Low risk	Quote: “Data for 2 participants were excluded from the analysis owing to incorrect dilution of the DPBS in their samples”
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