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

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.
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