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Clinical Outcomes of Bio-MA and ProRoot MTA in Endodontic Treatment

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ClinicalTrials.gov Identifier: NCT04243993
Recruitment Status : Recruiting
First Posted : January 28, 2020
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
Mahidol University

Tracking Information
First Submitted Date  ICMJE December 24, 2019
First Posted Date  ICMJE January 28, 2020
Last Update Posted Date January 28, 2020
Actual Study Start Date  ICMJE July 1, 2017
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2020)
  • Healed rate [ Time Frame: At least 1 year recall ]
    No clinical sign and symptoms and periapical area in radiograph is normal. Describe in percentage.
  • Healing rate [ Time Frame: At least 1 year recall ]
    No clinical sign and symptoms and periapical lesion in radiograph is reduce in size. Describe in percentage.
  • Disease rate [ Time Frame: At least 1 year recall ]
    Clinical sign and symptoms is present and/or periapical lesion in radiograph is unchange or enlarge. Describe in percentage.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Outcomes of Bio-MA and ProRoot MTA in Endodontic Treatment
Official Title  ICMJE Clinical Outcomes of Bio-MA and ProRoot MTA in Non-surgical and Surgical Endodontic Treatment: a Randomized Controlled Clinical Trial
Brief Summary The purpose of this study is to compare the endodontic outcomes of Bio-MA and ProRoot MTA in pulpotomy, orthograde MTA apical barrier, root perforation repair, endodontic microsurgery.
Detailed Description The patients were recruited at the Endodontic clinic, Faculty of Dentistry, Mahidol University, Thailand. Each treatment was provided following the standard protocol. The calcium silicate based material (Bio-MA or ProRoot MTA) was randomly selected and used in the treatment. The patients were periodically recalled at 6 to 12 months. The outcome of the three treatments based on the clinical and radiographic criteria was assessed by the calibrated examiners and interpreted as ''healed/healing" or ''disease.''
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Clinical Outcome
  • Endodontic Disease
Intervention  ICMJE Other: Calcium silicate cement
Calcium silicate cement for using in endodontic treatments i.e. pulpotomy, orthograde MTA apical barrier, root perforation repair, and endodontic microsurgery.
Study Arms  ICMJE
  • Bio-MA
    Calcium silicate cement containing calcium chloride accelerator
    Intervention: Other: Calcium silicate cement
  • ProRoot MTA
    Calcium silicate cement without calcium chloride accelerator
    Intervention: Other: Calcium silicate cement
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: January 26, 2020)
60
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2024
Estimated Primary Completion Date December 31, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Teeth treated with pulpotomy, orthograde MTA apical barrier, root perforation repair or endodontic microsurgery

Exclusion Criteria:

  • Teeth with un-restorable condition
  • Teeth with crack or fracture
  • Teeth with external or internal root resorption
  • Teeth with chronic periodontitis with marginal bone loss more than 5 mm
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 10 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Danuchit Banomyong, Ph.D. 022007622 danuchit.ban@mahidol.ac.th
Listed Location Countries  ICMJE Thailand
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04243993
Other Study ID Numbers  ICMJE MU-DT/PY-IRB 2016/052.0310
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mahidol University
Study Sponsor  ICMJE Mahidol University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Supachai Sutimuntanakul, TBOD Mahidol University
PRS Account Mahidol University
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP