Clinical trial NCT02783911: Comparison of Mineral Trioxide Aggregate (MTA) & Ferric Sulfate (FS) Pulpotomies
Official title: Comparison of Clinical and Radiographic Success Between Mineral Trioxide Aggregate (MTA) & Ferric Sulfate (FS) Pulpotomies for Primary Molars
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Primary Teeth
Pulpotomy
Keywords: Clinical and Radiograph
Lead sponsor: Loma Linda University
Sponsor class: OTHER
First posted: 2016-05-26
Enrollment: 57
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparison of clinical and radiographic success between Mineral Trioxide Aggregate and Ferric Sulfate pulpotomies for primary molars. Recall appointments are completed 6 months, 9 months and 12 months.

Detailed description: Comparison of clinical and radiographic success between Mineral Trioxide Aggregate and Ferric Sulfate pulpotomies for primary molars. Recall appointments are completed 6 months, 9 months and 12 months. Regular recall and follow up will be performed for patients who has MTA or FS pulpotomies. Clinical and radiographic findings will be recorded.

Eligibility criteria: Inclusion Criteria:

* ASA I,II
* Primary Molars diagnosed with normal or reversible pulpitis with vital carious pulp exposures
* Teeth that can have hemostasis can be achieved with pressure
* No clinical symptoms
* No radiographic signs of internal resorption or external root resorption

Exclusion Criteria:

* Primary Molars diagnosed with irreversible pulpitis or necrotic pulp
* Teeth that can not achieve hemostasis
* Teeth with abscess or fistula
* Teeth that have radiographic signs of internal resorption or external resorption

Primary outcomes:
measure: Comparison of the Clinical Success Between Mineral Trioxide Aggregate (MTA) & Ferric Sulfate (FS) Pulpotomies in Primary Molars
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Loma Linda University
name: Jung-Wei Chen, DDS,MS,PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Asgary S, Shirvani A, Fazlyab M. MTA and ferric sulfate in pulpotomy outcomes of primary molars: a systematic review and meta-analysis. J Clin Pediatr Dent. 2014 Fall;39(1):1-8. doi: 10.17796/jcpd.39.1.b454r616m2582373.
citation: Yildirim C, Basak F, Akgun OM, Polat GG, Altun C. Clinical and Radiographic Evaluation of the Effectiveness of Formocresol, Mineral Trioxide Aggregate, Portland Cement, and Enamel Matrix Derivative in Primary Teeth Pulpotomies: A Two Year Follow-Up. J Clin Pediatr Dent. 2016 Winter;40(1):14-20. doi: 10.17796/1053-4628-40.1.14.
citation: Stringhini Junior E, Vitcel ME, Oliveira LB. Evidence of pulpotomy in primary teeth comparing MTA, calcium hydroxide, ferric sulphate, and electrosurgery with formocresol. Eur Arch Paediatr Dent. 2015 Aug;16(4):303-12. doi: 10.1007/s40368-015-0174-z. Epub 2015 Apr 2.
citation: Frenkel G, Kaufman A, Ashkenazi M. Clinical and radiographic outcomes of pulpotomized primary molars treated with white or gray mineral trioxide aggregate and ferric sulfate--long-term follow-up. J Clin Pediatr Dent. 2012 Winter;37(2):137-41. doi: 10.17796/jcpd.37.2.j3h27p624u163868.