Back to resultsClinical Outcomes of Bio-MA and ProRoot MTA in Endodontic Treatment
Primary Purpose
Clinical Outcome, Endodontic Disease
Status
Recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Calcium silicate cement
Sponsored by
About this trial
This is an interventional treatment trial for Clinical Outcome
Eligibility 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
Sites / Locations
- Nuttida TungsuksomboonRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Bio-MA
ProRoot MTA
Arm Description
Calcium silicate cement containing calcium chloride accelerator
Calcium silicate cement without calcium chloride accelerator
Outcomes
Primary Outcome Measures
Healed rate
No clinical sign and symptoms and periapical area in radiograph is normal. Describe in percentage.
Healing rate
No clinical sign and symptoms and periapical lesion in radiograph is reduce in size. Describe in percentage.
Disease rate
Clinical sign and symptoms is present and/or periapical lesion in radiograph is unchange or enlarge. Describe in percentage.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04243993
Brief Title
Clinical Outcomes of Bio-MA and ProRoot MTA in Endodontic Treatment
Official Title
Clinical Outcomes of Bio-MA and ProRoot MTA in Non-surgical and Surgical Endodontic Treatment: a Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
January 2020
Overall Recruitment Status
Recruiting
Study Start Date
July 1, 2017 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.''
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Clinical Outcome, Endodontic Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Bio-MA
Arm Type
Other
Arm Description
Calcium silicate cement containing calcium chloride accelerator
Arm Title
ProRoot MTA
Arm Type
Other
Arm Description
Calcium silicate cement without calcium chloride accelerator
Intervention Type
Other
Intervention Name(s)
Calcium silicate cement
Intervention Description
Calcium silicate cement for using in endodontic treatments i.e. pulpotomy, orthograde MTA apical barrier, root perforation repair, and endodontic microsurgery.
Primary Outcome Measure Information:
Title
Healed rate
Description
No clinical sign and symptoms and periapical area in radiograph is normal. Describe in percentage.
Time Frame
At least 1 year recall
Title
Healing rate
Description
No clinical sign and symptoms and periapical lesion in radiograph is reduce in size. Describe in percentage.
Time Frame
At least 1 year recall
Title
Disease rate
Description
Clinical sign and symptoms is present and/or periapical lesion in radiograph is unchange or enlarge. Describe in percentage.
Time Frame
At least 1 year recall
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Danuchit Banomyong, Ph.D.
Phone
022007622
Email
danuchit.ban@mahidol.ac.th
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Supachai Sutimuntanakul, TBOD
Organizational Affiliation
Mahidol University
Official's Role
Study Director
Facility Information:
Facility Name
Nuttida Tungsuksomboon
City
Bangkok
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nuttida Tungsuksomboon, DDS
Phone
022007622
Email
ntd_tssb@hotmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Clinical Outcomes of Bio-MA and ProRoot MTA in Endodontic Treatment
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