NCT02783911

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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
57

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 29, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

May 18, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 26, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 14, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 14, 2017

Completed
4.2 years until next milestone

Results Posted

Study results publicly available

June 11, 2021

Completed
Last Updated

June 11, 2021

Status Verified

May 1, 2021

Enrollment Period

2.1 years

First QC Date

May 18, 2016

Results QC Date

March 11, 2021

Last Update Submit

May 17, 2021

Conditions

Primary TeethPulpotomy

Keywords

Clinical and Radiograph

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Mineral Trioxide Aggregate

EXPERIMENTAL

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

Device: MTA

Ferric Sulfate

EXPERIMENTAL

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

Drug: Ferric Sulfate

Interventions

MTADEVICE

Mineral Trioxide Aggregate grey paste

Mineral Trioxide Aggregate
Ferric SulfateDRUG

Ferric Sulfate paste

Also known as: FS
Ferric Sulfate

Eligibility Criteria

Age3 Years - 10 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • 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.

    PMID: 25631717BACKGROUND

  • 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.

    PMID: 26696101RESULT

  • 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.

    PMID: 25833280RESULT

  • 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.

    PMID: 23534318RESULT

MeSH Terms

Interventions

ferric sulfate

Results Point of Contact

Title
Dr. Jung-Wei Chen, Program director
Organization
LomaLindaU
jwchen@llu.edu
9095584690

Study Officials

  • Jung-Wei Chen, DDS,MS,PhD

    Loma Linda University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pediatric Dental Director

Study Record Dates

First Submitted

May 18, 2016

First Posted

May 26, 2016

Study Start

January 29, 2015

Primary Completion

March 14, 2017

Study Completion

March 14, 2017

Last Updated

June 11, 2021

Results First Posted

June 11, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share