- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02783911
Comparison of Mineral Trioxide Aggregate (MTA) & Ferric Sulfate (FS) Pulpotomies
May 17, 2021 updated by: Jung-Wei Chen, DDS, MS, PhD, Loma Linda University
Comparison of Clinical and Radiographic Success Between Mineral Trioxide Aggregate (MTA) & Ferric Sulfate (FS) Pulpotomies for Primary Molars
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
57
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
3 years to 10 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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
|
Mineral Trioxide Aggregate grey paste
|
Experimental: 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
|
Ferric Sulfate paste
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of the Clinical Success Between Mineral Trioxide Aggregate (MTA) & Ferric Sulfate (FS) Pulpotomies in Primary Molars
Time Frame: 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
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jung-Wei Chen, DDS,MS,PhD, Loma Linda University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 29, 2015
Primary Completion (Actual)
March 14, 2017
Study Completion (Actual)
March 14, 2017
Study Registration Dates
First Submitted
May 18, 2016
First Submitted That Met QC Criteria
May 23, 2016
First Posted (Estimate)
May 26, 2016
Study Record Updates
Last Update Posted (Actual)
June 11, 2021
Last Update Submitted That Met QC Criteria
May 17, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 5140262
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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