| Methods |
RCT, parallel‐arm
Teeth randomly assigned
Conducted in the University Center Heminio Ometto, School of Dentistry, Araras, Sao Paulo, Brazil. Operators not mentioned |
| Participants |
29 children, 51 teeth, age range 4.5 to 6.5 years |
| Interventions |
Group 1:Pulpotomy (formocresol); n = 28 (4 visits)
Rubber dam Caries removal prior to pulpal access Pulp access with high‐speed bur Pulpotomy amputation with excavator For haemostasis, dry cotton pellet Irrigation with 0.5% saline Pulpotomy, FC used. "The cavity was provisionally restored with an IRM …After 7 days, …the FC dressing was changed, and the cavity was sealed with an IRM again. After another 7 days, …the dressing was removed and the coronal chamber was restored with a slow‐setting pure ZOE. The tooth was sealed with IRM. One month later, the treated primary molars were restored with a glass‐ionomer cement …If the restoration was not satisfactory, it was substituted with a performed stainless steel crown"
Group 2:Pulpectomy (calcium hydroxide); n = 23 (4 visits)
Rubber dam Caries removal prior to pulpal access Pulp access with high‐speed bur Pulpotomy amputation with excavator For haemostasis, moistened cotton pellet with saline Irrigation with 0.5% saline Instrumentation with endodontic files Pulpectomy then CH "The tooth was temporarily sealed with an IRM …placed over a cotton pellet... After 7 days …a new calcium hydroxide paste dressing was introduced …and the tooth was temporarily sealed again. After an additional 7 days, definitive obturation of the canals was performed with calcium hydroxide paste …thickened with calcium hydroxide powder …and the tooth was sealed with IRM" "One month later, the treated primary molars were restored with a glass‐ionomer cement …If the restoration was not satisfactory, it was substituted with a performed stainless steel crown"
|
| Outcomes |
No data provided |
| Notes |
Dropouts: no information provided
Follow‐up for 48 months; reporting at baseline, 12, 24, 26, 48 months
Source of funding: not reported |
| 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 |
Insufficient information to make a clear judgement |
| 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 |
Unclear risk |
Insufficient information to make a clear judgement |
| Selective reporting (reporting bias) |
Unclear risk |
Insufficient information to make a clear judgement |
