Baltimore, Maryland 21043


Purpose:

In primary teeth, decay that is near the pulp (tooth nerve)is treated with either a pulpotomy or indirect pulp treatment if the tooth is not going to be extracted A pulpotomy involves removing the top 1/2 of the pulp, placing a medication/material on the pulp, covering the remaining pulp with a cement, and the restoring the tooth. The purpose of this pilot study is to gain preliminary information regarding the success of Biodentine, MTA, and IPT in the treatment of deep decay in children's primary molars.


Study summary:

Pediatric 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 pediatric dentists or they will directly supervise pediatric 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 pediatric 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.


Criteria:

Inclusion Criteria: - Pediatric patients with deep dental decay in primary molars - Teeth with signs and symptoms of reversible pulpitis Exclusion Criteria: - Teeth with clinical symptoms of irriversible 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


NCT ID:

NCT02298504


Primary Contact:

Vineet Dhar, MDS, PhD
Phone: 4107067970
Email: vdhar@umaryland.edu


Backup Contact:

N/A


Location Contact:

Baltimore, Maryland 21043
United States

Vineet Dhar
Email: vdhar@umaryland.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 19, 2017

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