King 1997.
| Study characteristics | ||
| Methods | Trial design: RCT – split‐mouth design Location: Baylor College of Dentistry, Dallas, 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: 21 to 63 years; mean age 39 years Total number of participants: 12 (1 male, 11 female) Inclusion criteria: currently not taking antibiotics, not wearing a cardiac pacemaker, absence of respiratory infection Exclusion criteria: not mentioned Number randomized: 12 Number evaluated (withdrawals/missing participants): 12 (none) | |
| Interventions |
Comparison: HVE versus no HVE Intervention: Group name: with aerosol reduction device (ARD) Number of intervention groups: 1 Number randomized to intervention group: 12 Description of intervention: split mouth ‒ 1 side (maxillary and mandibular) of the mouth was scaled by using a magneto‐strictive ultrasonic scaler without the aerosol reduction device (control), and the opposing side was scaled by using the ultrasonic scaler with the aerosol reduction device (intervention). Any co‐interventions: nil Comparator: Group name: without ARD Number of control groups: 1 Number randomized to control group: 12 Description of control: as above. |
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| Outcomes | Outcome name: reduction in contamination of aerosol (at 6 inches from the participant's mouth and on face shield)
Outcome measurement: CFU. "Three blood agar plates were then placed 6 inches in front of patient's mouth, right and left side. To ensure that the entire area of the face shield was sampled, 3× 21/i‐inch RODAC plates were used. The right, middle, and left sides of the face shield were lightly pressed by separate RODAC plates."
Effect estimate: mean (SD) Key conclusions: "these data suggest that an aerosol reduction device is effective in reducing the number of microorganisms generated during ultrasonic scaling, therefore decreasing the risk of disease transmission." |
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| Notes | We wanted to contact the study author for method of randomisation, allocation concealment, blinding and study protocol, but their e‐mail details were not available. | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | No details about method of randomisation: "The right or left side of the subject's mouth was randomly assigned to one of the two 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 | Quebec Colony Counter (Leica, Deerfield, IL) was used to count the colonies, which is an automated colony counter and is an objective finding. |
| 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 |