NCT02393326.

Trial name or title	Biodentine Partial Pulpotomy of Pulpally Exposed Primary Molars
Methods	Prospective Study population: 100 participants Study group: sample comprises mandibular primary molars from boys and girls aged between 3 and 7 years. The children have no systemic diseases according to the medical history supplied by the parents or guardians. The mandibular primary molars in this study are selected according to the following clinical and radiographic criteria. The clinical criteria: the presence of a deep carious lesion, sufficient tooth structure for restoration with a stainless steel crown, no history of spontaneous pain, tenderness to percussion or abnormal mobility, abscess, fistula, or swelling of the gingiva, and with cessation of bleeding after a 2 mm depth of the pulp at the area of the exposure was amputated. The radiographic criteria: a deep carious lesion in close proximity to the pulp without furcation or radicular pathology, obliteration of the pulp and root canal, or internal or external root resorption. Physiologic root resorption, while included in the criteria, could not be more than one‐third of the root length. Clinical technique: all teeth will be treated under local anaesthesia with rubber dam isolation. After caries removal resulted in a pulp exposure, the pulp at the exposed area is amputated to a depth of 2 mm using a water‐cooled high‐speed handpiece with a #330 high‐speed bur. The wound surface is irrigated with sterile saline solution and dried with cotton pellets to avoid clot formation. After homeostasis is obtained, an assistant drew lots to randomly allocate the case to either the PP or the FP treatment group. The child will not know which treatment is assigned to each tooth. For the PP group, biodentine is gently applied to the wound surface, and then covered with reinforced zinc oxide‐eugenol (IRM_; Dentsply). For the FP group, coronal access is obtained using high‐speed handpiece with a #330 high‐speed bur with water spray to further expose the pulp chamber. Following removal of the coronal pulp and achievement of homeostasis, a cotton pellet moistened with formocresol (1: 5 Buckley's solution) is placed on the amputated pulp for 5 min. The pulp stumps is then covered by IRM. After PP or FP treatment, all teeth are restored with a stainless steel crown. Follow‐up: the follow‐up for clinical and radiographic evaluation will be carried out at 6‐month intervals. Treatment is considered a clinical failure if one or more of the following signs are observed: pain, abscess or sinus opening, tenderness upon percussion, or abnormal tooth mobility. For radiographic evaluation, the treatment is rated as a failure when one or more of the following signs are present: furcation or periapical radiolucency, pathologic external root resorption, or internal resorption. The treatment is regarded successful if both the clinical and radiographic evaluation does not indicate any signs of failure.
Participants	Inclusion criteria Clinical criteria: primary molar with a deep carious lesion Sufficient tooth structure for restoration with a stainless steel crown No history of spontaneous pain Tenderness to percussion or abnormal mobility Abscess, fistula, or swelling of the gingiva, and with cessation of bleeding after a 2 mm depth of the pulp at the area of the exposure was amputated. Radiographic criteria: a deep carious lesion in close proximity to the pulp without furcation or radicular pathology Obliteration of the pulp and root canal, or internal or external root resorption Physiologic root resorption, while included in the criteria, could not be more than one‐third of the root length 3 to 7 years Exclusion criteria Clinical criteria: history of spontaneous pain Tenderness to percussion or abnormal mobility Abscess, fistula, or swelling of the gingiva, no cessation of bleeding after a 2 mm depth of the pulp at the area of the exposure was amputated. Radiographic criteria: tooth with furcation or radicular pathology Obliteration of the pulp and root canal, or internal or external root resorption Physiologic root resorption more than one‐third of the root length
Interventions	Experimental: partial pulpotomy with biodentine Biodentine is gently applied to the pulp stumps Interventions: Procedure: partial pulpotomy with biodentine Drug: biodentine Formocresol pulpotomy: a cotton pellet moistened with formocresol (1: 5 Buckley's solution) is placed on the amputated pulp for 5 min. Interventions: Procedure: formocresol pulpotomy Drug: formocresol
Outcomes	Primary Partial pulpotomy clinical success rate (time frame 6‐month intervals, up to 2 years. From date of randomisation until the date of first documented failure or up to 24 months). Treatment is considered a clinical failure if one or more of the following signs are observed: pain, abscess or sinus opening, tenderness upon percussion, or abnormal tooth mobility. The treatment is regarded successful if clinical evaluation does not indicate any signs of failure. Partial pulpotomy radiographic success rate (time frame: 6‐month intervals, up to 2 years. From date of randomisation until the date of first documented failure or up to 24 months). For radiographic evaluation, the treatment is rated as a failure when one or more of the following signs are present: furcation or periapical radiolucency, pathologic external root resorption, or internal resorption. The treatment is regarded successful if radiographic evaluation does not indicate any signs of failure. Secondary Formocresol pulpotomy clinical success rate [ Time Frame: 6‐month intervals, up to 2 years. From date of randomization until the date of first documented failure or up to 24 months ]Treatment is considered a clinical failure if one or more of the following signs are observed: pain, abscess or sinus opening, tenderness upon percussion, or abnormal tooth mobility. The treatment is regarded successful if clinical evaluation does not indicate any signs of failure. Formocresol pulpotomy radiographic success rate (time frame: 6‐month intervals, up to 2 years. From date of randomisation until the date of first documented failure or up to 24 months). For radiographic evaluation, the treatment is rated as a failure when one or more of the following signs are present: furcation or periapical radiolucency, pathologic external root resorption, or internal resorption. The treatment is regarded successful if radiographic evaluation does not indicate any signs of failure.
Starting date	May 2015
Contact information	Contact: Avia Fux‐Noy, DMD, Contact: Hadas Lemberg, PhD
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