Devker 2012.
| Study characteristics | ||
| Methods | Trial design: CCT – split mouth (multi‐arm – but in our trial only 1 group comparing with and without HVE was used) Location: STES dental college and hospital, Pune, Maharashtra, India Setting: dental clinic Language: English Number of centres: 1 Study period: not mentioned Funding source: not mentioned Study protocol: not available | |
| Participants | Age: 18 to 45 years Total number of participants: 30 (for HVE group, which is of interest for this review) Inclusion criteria:
Exclusion criteria:
Number randomized: 30. However, both the sides of the mouth and the order of the intervention were not randomised Number evaluated (withdrawals/missing participants): 30 |
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| Interventions |
Comparison: HVE versus no HVE Intervention: •Group I: rinse with 0.2% chlorhexidine gluconate prior to scaling •Group II: use of HVE during ultrasonic scaling •Group III: rinse with 0.2% chlorhexidine gluconate prior to scaling and use of HVE during ultrasonic scaling Group name: group II ‐ test side ‐ presence of high‐volume evacuator alone Number of intervention groups: 1 Number randomized to intervention group: 30 Description of intervention: oral prophylaxis was done on a randomly selected side (control side) for a period of 10 minutes. After a gap of 30 minutes, high‐volume suction tip was tied to the ultrasonic scaler. Oral prophylaxis was done on the other side (test side) of the same arch with high‐volume suction for a period of 10 minutes. Following the 10‐minute sampling period, blood agar plates were taken off. Any co‐interventions: no (2 other groups were present: Group I ‐ with preprocedural rinse and Group III ‐ with preprocedural rinse + HVE, which are not relevant to our review) Comparator: Group name: group II – control side ‐ absence of high‐volume evacuator Number of control groups: 1 Number randomized to control group: 30 |
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| Outcomes | Outcome name: reduction of microbial load in aerosols (blood agar plates were used to check CFU in 4 areas)
Reference point: mouth of the patient • At 6 inches (half a foot) from reference point (operator’s nose level) • At 6 inches (half a foot) from reference point (assistant’s nose level) • At 12 inches (1 foot) from reference point (participant’s chest level) • At 36 inches (3 foot) from reference point on participant’s right Outcome measurement: CFU Effect estimate: mean (SD not given) Key conclusions: the results of this study showed that preprocedural rinse and high‐volume suction were effective when used alone as well as together in reducing the microbial load of the aerosols produced during ultrasonic scaling. |
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| Notes | Study authors contacted for: random sequence generation, allocation concealment, blinding of participants and personnel 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) | High risk | Sides of the mouth and the order of the intervention were not randomised |
| Allocation concealment (selection bias) | High risk | Sides of the mouth and the order of the intervention were not randomised |
| 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 | CFU is measured using digital colony counter, which is an objective method and will not be affected by blinding |
| 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 |