El‐Din 1997.
| Study characteristics | ||
| Methods | Trial design: RCT ‐ 4 arms and each arm had a split‐mouth design Location: Faculty of Dentistry, Tanta University, Egypt Setting: dental partition measuring 2 m × 3 m in the pedodontics clinic Language: English Number of centres: 1 Study period: not mentioned Funding source: none mentioned Study protocol: not available | |
| Participants | Age: 5 to 10 years Total number of participants: 20 (10 per group) Inclusion criteria:
Exclusion criteria: not mentioned Number randomized: 20 Number evaluated (withdrawals/missing participants): 20 (none) |
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| Interventions |
Comparison: rubber dam versus no rubber dam Intervention: Group 1: conservative procedures performed under rubber dam isolation Group 2: CHX mouthrinse 30 minutes before starting the conservative procedure Group 3: CHX mouthrinse before application of the rubber dam Group 4 (control): conservative procedures performed without rubber dam isolation We used group 1 and group 4 data only. Number of intervention groups: 1 Number randomized to intervention group: 10 Description of intervention: 2 different methods of bacterial reduction were used for each child. Adjacent lesions were restored at appointments at least 1 week apart. The operative procedures were performed in the morning to minimize aerosol particle contamination of the environment. An air‐turbine‐driven handpiece was used, and the patient was seated in a reclining position. The length of the procedure varied from 5 to 15 minutes. The windows of the dental partition were opened prior to the procedure to ventilate the partition but were closed 30 minutes before recording background levels of atmospheric bacteria. The selection of the bacterial reduction method, the restoration of the caries tooth and the appointment were randomized and divided into 4 groups: 2 intervention and 2 control groups Any co‐interventions: no Comparator: Group name: conservative procedures performed without rubber dam isolation Number of control groups: 1 Number randomized to control group: 10 Description of control: same as above except that the control group was without rubber dam isolation |
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| Outcomes | Outcome name: reduction in contamination of aerosols (measured equidistantly from the child's head, 1 each on the chest, on the left and right sides and behind the participant. Another 2 plates were placed 1 metre and 2 metres from the head‐rest of the dental chair) (measured by reduction in CFU) Outcome measurement: CFU Effect estimate: mean (SD) Key conclusions: during conservative procedure without rubber dam, which involved 5 to 15 minutes work on the patient, the airborne bacterial load increased from 8.8 to 25.1 CFU. The results of this study are comparable to those of other studies on the barrier efficiency of rubber dam. | |
| Notes | Study author to be contacted for: random sequence generation, allocation concealment and study protocol. 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) | Unclear risk | No details available |
| 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 | 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 |