Magnusson 1977.
Study characteristics | ||
Methods | RCT, parallel groups Duration of study: in 1 group, no follow‐up; in the other (SW), follow‐up associated with this treatment (6 weeks) Setting: 1 university in Sweden |
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Participants | 62 children, 110 molars Age: 5–10 years Inclusion criteria: primary molars with deep carious lesions Exclusion criteria: signs of pulpitis (i.e. episodes of persistent or shooting pain, tooth that were tender to percussion), radiographic signs of pathological periradicular or internal pulp changes |
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Interventions | 2 treatment arms Group 1 (62 participants, 55 teeth): excavation until all softened dentine had been removed; no information on final restoration measures and material. Group 2 (62 participants, 55 teeth): excavation until a thin layer of soft dentine remained on the pulpal cavity floor; washing of the cavity with a microbiocidal solution; covering of remaining carious tissue with calcium hydroxide; bonding of the dressing with a thin layer of cement; sealing of the cavity with zinc‐oxide‐eugenol cement; reopening after 4–6 weeks; removing of all softened tissue; no information on final restoration measures and material; in 9 cases a second period of 4 weeks of calcium‐hydroxide dressing was considered necessary. |
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Outcomes |
Primary outcome Pulp exposure and pulpal complications between treatment steps (only for SW group) |
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Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | If the child was born on an odd day of the month, the molar was excavated step by step; if born on an even day of the month, immediate complete removal of softened carious dentine. |
Allocation concealment (selection bias) | High risk | Due to predictable nature. No concrete method for allocation concealment reported. |
Blinding of participants and personnel (performance bias) All outcomes | High risk | No blinding of participants/operators. |
Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | No blinding of assessor reported. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No attrition occurred. |
Selective reporting (reporting bias) | Unclear risk | No study protocol available – insufficient information to permit judgement of low or high risk of bias. Incomplete description of the intervention, i.e. on how complete excavation was defined. |
Other bias | Unclear risk | Missing information on the depth of lesions in the included teeth. |