Yadav 2014.
Methods | RCT, parallel‐arm Teeth randomly assigned Conducted in Sudha Rustagi Dental College, Faridabad. Operator not mentioned |
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Participants | 37 children, 45 teeth, age range 4 to 7 years | |
Interventions |
Group 1:Pulpotomy (15.5% ferric sulphate); n = 15 (1 visit)
Cotton pellet was first saturated with 15.5% ferric sulphate and later compressed between gauze to remove excess so it was just moistened with the solution. It was then placed for 15 seconds on amputated pulp stumps. After this the pulp stumps were observed for brownish to black discolouration of the fixed radicular pulp tissue. Excess ferric sulphate was flushed from the pulp chamber with copious amount of saline and clot remnants were removed from the chamber followed by placement of a thick mix of zinc oxide eugenol into the pulp chamber. Then teeth restored by glass ionomer cement Group 2:Pulpotomy (electrosurgery); n = 15 (1 visit)
The ART‐E1 electrosurgery unit was set at COAG 1 mode to perform both electrofulguration and electrocoagulation. The handpiece with appropriate electrode tips, kept 1 to 2 mm away from the pulpal tissue, was used to deliver the electric current. The duration of application was not more than 2 to 3 seconds followed by a cool down period of 5 seconds. If necessary, this procedure was repeated up to a maximum of three times. After each current application, a new large moist sterile cotton pellet was placed with pressure on the pulpal tissue near to orifice to absorb any blood or tissue fluids before the next current application (e.g. pellet‐electrode‐pellet‐electrode). When properly completed, the pulpal stumps appeared dry and completely blackened. This was followed by placement of a thick mix of zinc oxide eugenol into the pulp chamber. Then teeth restored by glass ionomer cement Group 3:Pulpotomy (diode laser); n = 15 (1 visit)
The remaining coronal pulp tissue was exposed to laser energy through an optical fibre using the diode laser (810 nm, output power: 7 W) set at 3 W of power in Continuous Wave. The laser energy was delivered through a 400 μm diameter optical fibre in a non contact mode with pulp tissue for not more than 2‐3 sec (PD = 2388.53, Fluence = 7165.60). Application of laser was administered until the pulp was ablated and complete haemostasis was achieved. All children and clinical staff wore appropriate eye protection during application of the laser. Applications were administered as per the requirement of each tooth followed by placement of a thick mix of zinc oxide eugenol into the pulp chamber. Then teeth restored by glass ionomer cement |
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Outcomes | Clinical success (absence of pain and tenderness, absence of abscess, absence of sinus or fistula, absence of mobility), radiographic success (absence of widened periodontal space, absence of inter‐radicular or periapical radiolucency, absence of sinus or fistula, absence of internal resorption, absence of abnormal canal calcification): 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 | 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 | Low risk | Proportion of missing outcomes < 10% children randomly assigned |
Selective reporting (reporting bias) | Unclear risk | Insufficient information to make a clear judgement |