Samaranayake 1989.
Study characteristics | ||
Methods | Trial design: CCT Location: University of Glasgow, Dental Hospital and School, UK Setting: 12 feet by 15 feet in the pedodontic clinic Language: English Number of centres: 1 Study period: not mentioned Funding source: not mentioned Study protocol: not available | |
Participants | Age: 10 to 14 years Total number of participants: 20 Inclusion criteria: children who required restorative procedures Exclusion criteria: not mentioned Number of participants: 20 (10 per group) Confounding factors: not found Selection bias: not found Method of blinding: not available Number evaluated (withdrawals/missing participants): 20 (none) | |
Interventions |
Comparison: rubber dam versus no rubber dam Intervention: Group name: with rubber dam Number of intervention groups: 1 Number in intervention group: 10 Description of intervention: 10 children in the intervention group underwent restorative procedures with rubber dam. Any co‐interventions: no Comparator: Group name: without rubber dam Number of control groups: 1 Number in control group: 10 Description of control: 10 children in the control group underwent restorative procedures without rubber dam. |
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Outcomes | Outcome name: reduction in contamination of aerosols (measured at 1 metre, 2 metres, 3 metres from head rest) Outcome measurement: CFU Effect estimate: mean + SE Key conclusions: results indicate that the use of a rubber dam perioperatively is associated with significantly higher bacterial aerosol levels and bacterial reduction was greatest 1 metre from head rest. | |
Notes | Study author to be contacted for: method of randomisation, allocation concealment, blinding and study protocol. Study is 31 years old – missing data unlikely to be traceable. We could not contact the authors as their e‐mail details were not available. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Details on confounding factors not found |
Allocation concealment (selection bias) | High risk | Details of selection process not 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 | Unclear risk | It is not clear if the CFU were manually counted or any automated colony counters were used – there is subjectivity if manually counted. |
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 |