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

Not Applicable

Terminated

• Conditions: Primary Teeth; Pulpotomy
• Interventions: Device: MTA; Drug: Ferric Sulfate

• Registration Number: NCT02783911
• Lead Sponsor: Loma Linda University

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.

Study Timeline

• Study Start: 2015-01-29
• Study First Submitted: 2016-05-18
• Study First Submitted QC: 2016-05-23
• Study First Posted: 2016-05-26
• Primary Completion: 2017-03-14
• Study Completion: 2017-03-14
• Results First Submitted: 2021-03-11
• Status Verified: 2021-05
• Results First Submitted QC: 2021-05-17
• Last Update Submitted: 2021-05-17
• Results First Posted: 2021-06-11
• Last Update Posted: 2021-06-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 57

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Mineral Trioxide Aggregate	MTA	Subject with pulpotomy treated with MTA MTA paste (\< 1gm) will be placed on pulp orifice once for the life of the primary teeth
Ferric Sulfate	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

Primary Outcome Measures

Name	Time	Method
Comparison of the Clinical Success Between Mineral Trioxide Aggregate (MTA) & Ferric Sulfate (FS) Pulpotomies in Primary Molars	1 year	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