Goyal 2014.
| Methods | RCT, parallel arm Teeth randomly assigned Setting not mentioned. Conducted in India. Operator not mentioned |
|
| Participants | 41 children, 45 teeth, age range 4 to 8 years | |
| Interventions |
Group 1:Pulpotomy (full strength formocresol); n = 15 (2 visits)
Group 2:Pulpotomy (1:5 diluted formocresol); n = 15 (2 visits)
Group 3:Pulpotomy (1:25 diluted formocresol); n = 15 (2 visits) No details 1:25 diluted FC: 18 mL glycerine and 6 mL distilled water are thoroughly mixed and to which 1 part of FC is added. A number 1 foam pellet saturated with 1:25 diluted FC then twice squeezed to remove excess 1:25 diluted FC and placed for 5 minutes. Then teeth restored with stainless‐steel crown (second visit) |
|
| Outcomes | Clinical failure (pain, intra‐oral/extra‐oral swelling, tenderness on percussion, sinus/fistula), radiological failure (furcation radiolucency, periapical changes, internal/external resorption): evaluation at 1, 3, 6 and 9 months | |
| Notes | ||
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Insufficient information to make a clear judgement |
| Allocation concealment (selection bias) | Unclear risk | Insufficient information to make a clear judgement |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "the subjects were unaware of their group" Insufficient information to make a clear judgement for blinding of personnel |
| Blinding of clinical outcomes assessment | Unclear risk | Insufficient information to make a clear judgement |
| Blinding of radiological outcomes assessment | Unclear risk | Insufficient information to make a clear judgement |
| Incomplete outcome data (attrition bias) All outcomes | High risk | Proportion of missing outcomes > 10% of children randomly assigned at 9 months |
| Selective reporting (reporting bias) | Unclear risk | Insufficient information to make a clear judgement |