| Methods |
RCT, parallel‐arm
Teeth randomly assigned
Conducted in Turkey. Operator was a paediatric dentist |
| Participants |
50 children, 50 teeth, age range 4 to 9 years |
| Interventions |
Group 1:Pulpectomy (IRM); n = 25 (3 visits)
isolation with no precision Caries removal prior to pulpal access Pulp access with no precision Pulpotomy amputation with no precision Irrigation with 2.5% sodium hypochlorite and physiological saline Instrumentation with H‐files canals were dried with paper points and Cresophene was applied in the pulp chamber with a cotton pellet and tooth was filled with Cavit. After 48 hours, canals were irrigated with NaOCl and physiologic saline, dried with paper points, and filled with a Ca(OH)2/iodoform paste using plastic syringe provided by the manufacturer and Lentulo spirals. Following root canal fillings, base materials were applied to the cavity floor and cavities were temporarily filled with IRM. IRM was removed from the cavity until approximately 3mm of the material is left on the pulpal floor and the cavity was filled with metal‐reinforced glass ionomer cement, before being restored with stainless steel crowns
Group 2:Pulpectomy (MTA); n = 25 (3 visits)
isolation with no precision Caries removal prior to pulpal access Pulp access with no precision Pulpotomy amputation with no precision Irrigation with 2.5% sodium hypochlorite and physiological saline Instrumentation with H‐files
canals were dried with paper points and Cresophene was applied in the pulp chamber with a cotton pellet and tooth was filled with Cavit. After 48 hours, canals were irrigated with NaOCl and physiologic saline, dried with paper points, and filled with a Ca(OH)2/iodoform paste using plastic syringe provided by the manufacturer and Lentulo spirals. Following root canal fillings, base materials were applied to the cavity floor and cavities were temporarily filled with IRM. after approximately 3mm of MTA was placed on the pulpal floor a moistened cotton pellet in contact to MTA was left in the cavity before the application of the temporary filling material. After 24 hours, temporary filling and moistened cotton pellet were removed and the cavity was filled with metal‐reinforced glass ionomer cement, before being restored with stainless steel crowns
|
| Outcomes |
Clinical failure (pain, pathological mobility, tenderness to percussion and palpation, and any soft tissue pathology and sinus tract) and radiographical failure (pathological root resorption, reduced size or healing of existing lesion, and absence of new lesions at the interradicular or periapical area): evaluation at 3, 6, 12 and 18 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 |
Insufficient information to make a clear judgement |
| Blinding of clinical outcomes assessment |
Low risk |
Quote: "Examiners were blinded to the groups" |
| Blinding of radiological outcomes assessment |
Low risk |
Quote: "Examiners were blinded to the groups" |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
No missing data |
| Selective reporting (reporting bias) |
Unclear risk |
Insufficient information to make a clear judgement |
