Vital Pulp Treatment in Primary Teeth | RxWiki

Vital Pulp Treatment in Primary Teeth

Overview[ - collapse ][ - ]

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.
Condition	Vital Pulp Therapies Indirect Pulp Cap Pulpotomy
Intervention	Drug: Mineral Trioxide Aggregate Drug: Biodentin Drug: Vitrebond
Phase	Phase 4
Sponsor	University of Maryland Baltimore Dental School
Responsible Party	University of Maryland Baltimore Dental School
ClinicalTrials.gov Identifier	NCT02298504
First Received	November 14, 2014
Last Updated	November 19, 2014
Last verified	November 2014

Tracking Information[ + expand ][ + ]

First Received Date	November 14, 2014
Last Updated Date	November 19, 2014
Start Date	January 2015
Estimated Primary Completion Date	Not Provided
Current Primary Outcome Measures	Clinical success after pulpotomy [Time Frame: 3 years] [Designated as safety issue: No]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
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	Vital Pulp Treatment in Primary Teeth
Official Title	Evaluation of MTA Pulpotomy, Biodentine Pulpotomy, and Glass Ionomer Indirect Pulp Treatment in Primary Teeth
Brief Summary	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.
Detailed Description	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.
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment
Condition	Vital Pulp Therapies Indirect Pulp Cap Pulpotomy
Intervention	Drug: Mineral Trioxide Aggregate Drug: Biodentin Drug: Vitrebond
Study Arm (s)	Experimental: Indirect pulp cap IDP will be performed for this group Experimental: MTA pulpotomy MTA pulpotomy will be performed for this group Experimental: Biodentin pulpotomy Biodentin pulpotomy will be performed for this group

Recruitment Information[ + expand ][ + ]

Recruitment Status	Not yet recruiting
Estimated Enrollment	156
Estimated Completion Date	Not Provided
Estimated Primary Completion Date	January 2018
Eligibility 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
Gender	Both
Ages	2 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	Not Provided

Administrative Information[ + expand ][ + ]

NCT Number	NCT02298504
Other Study ID Numbers	HP-00058711
Has Data Monitoring Committee	Yes
Information Provided By	University of Maryland Baltimore Dental School
Study Sponsor	University of Maryland Baltimore Dental School
Collaborators	Not Provided
Investigators	Not Provided
Verification Date	November 2014