Pramila 2016.
Methods | RCT, parallel‐arm Teeth randomly assigned Conducted in Saveetha Dental College and Hospital, India. Operator was an investigator |
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Participants | 88 children, 129 teeth, age range 4 to 9 years | |
Interventions |
Group 1:Pulpectomy (RC Fill); n = 43 (1 visit)
RC Fill available in powder and liquid form, mixed to the desired consistency according to the manufacturer’s instructions. A Lentulo spiral was used to place the RC Fill, followed by glass ionomer cement, before being restored with stainless steel crown. Group 2:Pulpectomy (Vitapex); n = 43 (1 visit)
Vitapex available in preformed syringes. The syringe was inserted into the canal near the apex. The paste was extruded into the canal, and the syringe was then slowly withdrawn as it filled the entire canal, followed by glass ionomer cement, before being restored with stainless steel crown. Group 3:Pulpectomy (ZOE); n = 43 (1 visit)
ZOE available in powder and liquid form, mixed to the desired consistency according to the manufacturer’s instructions. An Endodontic Pressure Syringe was used to place ZOE, followed by glass ionomer cement, before being restored with stainless steel crown. |
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Outcomes | Clinical failure (pain, tenderness to percussion, swelling/abscess, mobility and draining fistula), radiographic failure (furcation, radiolucency, periapical radiolucency, internal root resorption, external root resorption, lamina dura, deviation in the path of eruption, intraradicular resorption, resorption of extruded material), overall success: evaluation at 6, 12 and 30 months | |
Notes | ||
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Random numbers table |
Allocation concealment (selection bias) | Low risk | Sequentially numbered, opaque and sealed envelopes |
Blinding of participants and personnel (performance bias) All outcomes | Low risk | Quote: "The participants and outcome assessors were blinded about the filling materials used" |
Blinding of clinical outcomes assessment | Low risk | Quote: "The participants and outcome assessors were blinded about the filling materials used" |
Blinding of radiological outcomes assessment | Low risk | Quote: "The participants and outcome assessors were blinded about the filling materials used" |
Incomplete outcome data (attrition bias) All outcomes | High risk | Proportion of missing outcomes > 10% of children randomly assigned |
Selective reporting (reporting bias) | Low risk | Protocol prospectively registered (CTRI/2011/06/001776). no discrepancies in outcomes between registered record and published RCT. |