Ammann 2013.
Study characteristics | ||
Methods | Design: parallel‐group RCT Recruitment period: not stated Administration setting: private dental clinic Country: Germany Funding source: Dentsply DeTrey, Konstanz, Germany |
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Participants | Number of participants randomised: 72 (rubber dam: 34; cotton rolls: 38) Randomisation unit: participant Age: 5.9 to 16.9 years, mean age 11.1 years Sex: 23 boys, 49 girls Inclusion criteria:
Exclusion criteria:
Number of participants evaluated: 72 (rubber dam: 34; cotton rolls: 38) Withdrawals/loss to follow‐up: no withdrawals |
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Interventions | Number of groups: 2 Intervention: rubber dam: "A suitable rubber dam clamp (Ivoryò; Sigma Dental Systems, Handewitt, Germany) was selected and applied. Afterwards, the rubber dam was placed over the clamp. Several teeth were included in the rubber dam in cases involving premolars, whereas for molars only the treated tooth was isolated" Control: cotton rolls: "The cotton rolls were positioned on the buccal and lingual region of the tooth to be sealed and were fixed by the operator's index finger and middle finger. Additionally, a saliva ejector was placed on the lingual side" Restorative treatment: pit and fissure sealants on premolars/molars |
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Outcomes | Outcomes:
Time points: immediately after restorative procedure |
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Notes | Adverse events: not stated No details on sample size or power calculation were provided |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Quote: "72 subjects successfully took part in the study and were divided into two parallel groups by a dental assistant by drawing sealed lots (test n = 34; control n = 38)" Comment: method stated and appropriate |
Allocation concealment (selection bias) | Unclear risk | Not stated Comment: insufficient information reported to make a judgement |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Comment: the operators and the participants could not be blinded |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not stated Comment: insufficient information reported to make a judgement |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No withdrawals |
Selective reporting (reporting bias) | High risk | Quote: "The time needed to finish the fissure sealing treatment was 12.4% (108 s [seconds]) less when using rubber dam (P < 0.05)" Comment: insufficient information reported to use the data in the analysis |
Other bias | Low risk | Comparable groups at baseline (age, gender, type of teeth treated) |