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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

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.

Condition or disease Intervention/treatment Phase
Clinical Outcome Endodontic Disease Other: Calcium silicate cement Not Applicable

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.''

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Clinical Outcomes of Bio-MA and ProRoot MTA in Non-surgical and Surgical Endodontic Treatment: a Randomized Controlled Clinical Trial
Actual Study Start Date : July 1, 2017
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Calcium

Arm Intervention/treatment
Bio-MA
Calcium silicate cement containing calcium chloride accelerator
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.

ProRoot MTA
Calcium silicate cement without calcium chloride accelerator
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.




Primary Outcome Measures :
  1. Healed rate [ Time Frame: At least 1 year recall ]
    No clinical sign and symptoms and periapical area in radiograph is normal. Describe in percentage.

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   10 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04243993


Contacts
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Contact: Danuchit Banomyong, Ph.D. 022007622 danuchit.ban@mahidol.ac.th

Locations
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Thailand
Nuttida Tungsuksomboon Recruiting
Bangkok, Thailand, 10400
Contact: Nuttida Tungsuksomboon, DDS    022007622    ntd_tssb@hotmail.com   
Sponsors and Collaborators
Mahidol University
Investigators
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Study Director: Supachai Sutimuntanakul, TBOD Mahidol University
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Responsible Party: Mahidol University
ClinicalTrials.gov Identifier: NCT04243993    
Other Study ID Numbers: MU-DT/PY-IRB 2016/052.0310
First Posted: January 28, 2020    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases
Calcium
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs