Comparison of Mineral Trioxide Aggregate (MTA) & Ferric Sulfate (FS) Pulpotomies

NCT ID: NCT02783911

Last Updated: 2021-06-11

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

57 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-29

Study Completion Date

2017-03-14

Brief Summary

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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

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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.

Conditions

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Primary Teeth Pulpotomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Mineral Trioxide Aggregate

Subject with pulpotomy treated with MTA MTA paste (\< 1gm) will be placed on pulp orifice once for the life of the primary teeth

Group Type EXPERIMENTAL

MTA

Intervention Type DEVICE

Mineral Trioxide Aggregate grey paste

Ferric Sulfate

Subject with pulpotomy treated with FS FS paste (\<1gm) will placed on pulp orifice once for 15 secs and removed on primary teeth

Group Type EXPERIMENTAL

Ferric Sulfate

Intervention Type DRUG

Ferric Sulfate paste

Interventions

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MTA

Mineral Trioxide Aggregate grey paste

Intervention Type DEVICE

Ferric Sulfate

Ferric Sulfate paste

Intervention Type DRUG

Other Intervention Names

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FS

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Loma Linda University

OTHER

Sponsor Role lead

Responsible Party

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Jung-Wei Chen, DDS, MS, PhD

Pediatric Dental Director

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jung-Wei Chen, DDS,MS,PhD

Role: PRINCIPAL_INVESTIGATOR

Loma Linda University

References

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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.

Reference Type BACKGROUND
PMID: 25631717 (View on PubMed)

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.

Reference Type RESULT
PMID: 26696101 (View on PubMed)

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.

Reference Type RESULT
PMID: 25833280 (View on PubMed)

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.

Reference Type RESULT
PMID: 23534318 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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5140262

Identifier Type: -

Identifier Source: org_study_id

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