Pulpotomy Clinical Trial
Official title:
Comparison of Clinical and Radiographic Success Between Mineral Trioxide Aggregate (MTA) & Ferric Sulfate (FS) Pulpotomies for Primary Molars
Verified date | May 2021 |
Source | Loma Linda University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 57 |
Est. completion date | March 14, 2017 |
Est. primary completion date | March 14, 2017 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 3 Years to 10 Years |
Eligibility | 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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Loma Linda University |
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. Review. — View 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. — View 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 — View 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 Cli — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of the Clinical Success Between Mineral Trioxide Aggregate (MTA) & Ferric Sulfate (FS) Pulpotomies in Primary Molars | At recall visits 6,9,12 months, blinded clinical examination will be completed by participating faculty members who are calibrated to clinical scaring criteria. Periapical radiographs will be taken and evaluated by 2 pediatric dentists and 1 endodontist, for presence of various pathologies. Scored based on the criteria established by Zurn and Seale 2008. Scores will be transferred to Microsoft Excel. The difference between the two materials will be analyzed using the Mann-Whiteney U test, chi-square test and Fisher's exact test. Intra- and inter-rater agreement will be measured for radiographic assessment using Cohen's kappa test | 1 year |
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