NCT02298504.

Trial name or title	Vital Pulp Treatment in Primary Teeth
Methods	Paediatric patients having deep decay in primary molars seen at UMMC, UMSOD, and University of Maryland Rehabilitation and Orthopaedic Institute, will be included in the sample. Teeth with deep caries, > 50% into dentin, will be randomly assigned using a table of random numbers to the three treatment groups: Group 1 pulpotomy with MTA, Group 2 pulpotomy with Biodentine, Group 3 indirect pulp treatment. Treatment will be performed by board certified paediatric dentists or they will directly supervise paediatric dental residents at each site as part of their regular protocol for treating deep caries. Radiographs will be taken as prescribed in the Guideline for taking Radiographs in Children by the American Academy of Pediatric Dentistry. Twice‐yearly clinical examinations will be performed by the treating dentists or paediatric dental residents to check for any soft tissue pathology such as abscess or mobility of treated tooth/teeth. If treatment success/failure consensus between the blinded dentists is not reached, a third dentist will be consulted. The success/failure data will be entered onto spreadsheets and examined statistically using statistical software.
Participants	Inclusion criteria Paediatric patients with deep dental decay in primary molars Teeth with signs and symptoms of reversible pulpitis 2 to 9 years (child) Exclusion criteria Teeth with clinical symptoms of irreversible pulpitis or pulp necrosis or acute dental infection Children with systemic illness that contraindicated vital pulp treatment such a sickle cell disease Teeth that are not restorable
Interventions	Experimental: Indirect pulp cap IDP will be performed for this group Intervention: Drug: Vitrebond Experimental: MTA pulpotomy MTA pulpotomy will be performed for this group Intervention: Drug: Mineral Trioxide Aggregate Experimental: Biodentin pulpotomy Biodentin pulpotomy will be performed for this group Intervention: Drug: Biodentin
Outcomes	Clinical success after pulpotomy (time frame: 3 years) No signs of abscess or any swelling related to the tooth, no signs of fistula or other pathology, no signs of pathologic mobility, no post‐operative pain, no pain on palpation or percussion of the tooth Clinical success after indirect pulp cap (time frame: 3 years) No signs of abscess or any swelling related to the tooth, no signs of fistula or other pathology, no signs of pathologic mobility, no post‐operative pain, no pain on palpation or percussion of the tooth Radiographic success after pulpotomy (time frame: 3 years) No signs of root resorption (internal or external), no signs of furcation involvement or periapical radiolucency, no signs of loss of lamina dura, presence of normal appearance of periodontal ligament space
Starting date	November 2015
Contact information	None
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