| Methods |
RCT, parallel‐arm
Teeth randomly assigned
Setting not mentioned. Conducted in Turkey. Operators were investigators |
| Participants |
67 children, 100 teeth, age range 5 to 9 years |
| Interventions |
Group 1:Direct pulp capping (calcium hydroxide); n = 20 (1 visit)
Rubber dam not mentioned Caries removal prior to pulpal access Pulp access not mentioned No pulpotomy amputation For haemostasis, "sterile cotton pellets were soaked in the 1.25% sodium hypochlorite solution and place over the exposure site for 62 seconds without pressure" Irrigation with saline Direct pulp capping. CH cement "a non‐gamma II type amalgam was placed into the cavity in small increments with special care not to damage the CH cement during condensation. After occlusal adjustments and burnishing, the tooth‐amalgam margins were etched with 37% phosphoric acid for 30 seconds, rinsed with water for 15 seconds; dried and sealed with a light‐cured fissure sealant material to prevent short‐term microleakage that could affect healing"
Group 2:Direct pulp capping (acetone‐based total‐etch adhesive); n = 20 (1 visit)
Rubber dam not mentioned Caries removal prior to pulpal access Pulp access not mentioned No pulpotomy amputation For haemostasis, "sterile cotton pellets were soaked in the 1.25% sodium hypochlorite solution and place over the exposure site for 62 seconds without pressure" Irrigation with saline Acetone‐based total‐etch adhesive. Then composite: "incremental technique (each increment was polymerised for 40 seconds). Following standard techniques for finishing and polishing, the restoration surface was re‐etched as group 1 and sealed with an unfilled light‐cured resin to minimize microleakage"
Group 3:Direct pulp capping (acetone‐based total‐etch adhesive ‐ non rinse conditioner); n = 20 (1 visit)
Rubber dam not mentioned Caries removal prior to pulpal access Pulp access not mentioned No pulpotomy amputation For haemostasis, "sterile cotton pellets were soaked in the 1.25% sodium hypochlorite solution and place over the exposure site for 62 seconds without pressure" Irrigation with saline Non‐rinse conditioner. Then treatment 2. Then composite: "incremental technique (each increment was polymerised for 40 seconds). Following standard techniques for finishing and polishing, the restoration surface was re‐etched as group 1 and sealed with an unfilled light‐cured resin to minimize microleakage"
Group 4:Direct pulp capping (acetone‐based total‐etch adhesive ‐ total etching); n = 20 (1 visit)
Rubber dam not mentioned Caries removal prior to pulpal access Pulp access not mentioned No pulpotomy amputation For haemostasis, "sterile cotton pellets were soaked in the 1.25% sodium hypochlorite solution and place over the exposure site for 62 seconds without pressure" Irrigation with saline Total‐etching with 36% phosphoric acid. 36% phosphoric acid gel on enamel margins for 15 seconds followed by extending gel application to the cavity for an additional 10 seconds with care not to contact the exposed pulp. Then treatment 2. Then composite: "incremental technique (each increment was polymerised for 40 seconds). Following standard techniques for finishing and polishing, the restoration surface was re‐etched as group 1 and sealed with an unfilled light‐cured resin to minimize microleakage"
Group 5:Direct pulp capping (acetone‐based total‐etch adhesive ‐ self‐etch); n = 20 (1 visit)
Rubber dam not mentioned Caries removal prior to pulpal access Pulp access not mentioned No pulpotomy amputation For haemostasis, "sterile cotton pellets were soaked in the 1.25% sodium hypochlorite solution and place over the exposure site for 62 seconds without pressure" Irrigation with saline Self‐etch adhesive system. Then treatment 2. Then composite: "incremental technique (each increment was polymerised for 40 seconds). Following standard techniques for finishing and polishing, the restoration surface was re‐etched as group 1 and sealed with an unfilled light‐cured resin to minimize microleakage"
|
| Outcomes |
Clinical success (no spontaneous pain or sensitivity (or both) to pressure/percussion, no fistula, oedema, abnormal mobility, or a combination), radiological success (no radiolucency at the inter‐radicular or periapical regions (or both), no internal or external (pathological) resorption that was not compatible with the expected resorption due to the exfoliation process), inter‐radicular radiolucency or periapical radiolucency, internal root resorption or external root resorption, pain symptoms or spontaneous pain: evaluation at 1, 3, 6, 9, 12, 18 and 24 months (at tooth level) |
| Notes |
Reasons for dropouts: 9 exfoliations (7 at 18 months, 2 at 24 months); 2 extractions (12 and 18 months), 1 extraction (6 months), 1 extraction (12 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 |
Low risk |
Quote: "...two calibrated operators, blinded to the treatments, performed the clinical ...recall examinations" |
| Blinding of radiological outcomes assessment |
Low risk |
Quote: "...two calibrated operators, blinded to the treatments, performed the ...radiological recall examinations" |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
Proportion of missing outcomes < 10% of children randomly assigned |
| Selective reporting (reporting bias) |
Unclear risk |
Insufficient information to make a clear judgement |
