NCT02789423.

Trial name or title	Clinical and radiographical evaluation of the effect of Dycal and Biodentine in DPC in primary teeth
Methods	"The aim of the present study is to compare Calcium Hydroxide cement (Dycal) and Calcium Silicate cement (Biodentine)TM as pulp capping agents in primary molars. The objective of this study include the evaluation of clinical and radiographic efficacy of Calcium Hydroxide cement (Dycal) and Calcium Silicate cement (Biodentine), and their response in direct pulp capping treatment on primary molars during a 6‐month follow‐up. After following the proper standardized procedure for direct pulp cap. In the current study direct pulp capping was performed using calcium hydroxide cement (Dycal) and Calcium Silicate cement (Biodentine) on 60 primary teeth of children equally divided between 2 study groups randomly of both sexes aged 4 to 9 years old. Complete case history was recorded in detail and intraoral periapical radiograph was also taken for teeth indicated for direct pulp capping. Written consent was obtained from the parents of participants before starting the procedure. Strict standardised procedure had been followed and the pulp capping agent (Dycal/Biodentine) were applied according to the manufacturer's instructions. Each participant was evaluated clinically and radiographically for any abnormal clinical signs and symptoms at one, three and six months postoperatively. Better results for the success of the study could be relatively enhanced by close attention to rigid criteria for case selection, standardisation of direct pulp capping procedure and meticulous performance of the procedure appear to be prerequisites for successful treatment."
Participants	Inclusion criteria Good health Co‐operative behaviour Informed consent from parents Primary molars with clinically active caries No history of spontaneous pain in teeth Restorable tooth with at least one half of root length present Absence of pathological mobility Absence of tenderness to percussion Normal gingiva and periodontal condition without the sign of pathology such as redness and swelling of vestibule, draining sinus tract or sensitivity to palpate in the vestibule Aged 4 to 9 years (child) In addition, the teeth treated by direct pulp capping had only a pinpoint mechanical exposure (0.5 mm to 1 mm), for which haemorrhage control could be achieved within two minutes before proceeding with direct pulp capping. Radiographically, there was absence of internal resorption, external resorption, periapical or furcation radiolucencies and pathology of succedaneous permanent tooth follicle. Exclusion criteria Children with a history of spontaneous pain, tooth tender to percussion, absence of underlying permanent teeth, internal/external root resorption, apical/furcal lesions, sinus tract, physiologic or pathologic luxation, and/or presence of abscess were excluded from the study.
Interventions	Active comparator: Dycal Intervention: drug: Dycal (calcium hydroxide). Intervention description: DPC using Dycal for direct pulp exposure was performed in 30 primary molar teeth after proper case selection. Clinical and radiographic evaluation was done. One month postoperative criteria evaluated were ‐ clinical criteria: spontaneous pain, Defective restoration/Recurrent caries, Sinus formation, TOP, soft tissue swelling and mobility. Radiographic criteria: defective restoration/recurrent caries, periapical or furcal radiolucency, pathological internal resorption, replacement resorption, intracanal calcification and physiological resorption. The follow‐up was at three and six months. Intervention: Procedure: Direct Pulp Capping using Dycal and Biodentine Active comparator: Biodentine Intervention: drug: Biodentine, Other names: Calcium Silicate. Intervention description: DPC using Biodentine for direct pulp exposure was performed in 30 primary molar teeth after proper case selection. Clinical and radiographic evaluation was done. One month post operative criteria were ‐ clinical criteria: spontaneous pain, defective restoration/recurrent caries, sinus formation, TOP, soft tissue swelling and mobility. Radiographic criteria: defective restoration/recurrent caries, periapical or furcal radiolucency, pathological internal resorption, replacement resorption, intracanal calcification and physiological resorption. The follow‐up was at three and six months. Intervention: Procedure: Direct Pulp Capping using Dycal and Biodentine
Outcomes	Evidence of effectiveness of Dycal and Biodentine as Direct Pulp Capping agent in primary molars confirmed by clinical and radiographic evaluation (time frame: 6 months)
Starting date	June 2014
Contact information	Dr Komal IM Gandhi, BDS, Dr Mishthu Solanki, MDS
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