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

Study Overview
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Brief Summary
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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
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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.''

Official Title
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Clinical Outcomes of Bio-MA and ProRoot MTA in Non-surgical and Surgical Endodontic Treatment: a Randomized Controlled Clinical Trial

Conditions
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Clinical Outcome, Endodontic Disease

Intervention / Treatment
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* Other: Calcium silicate cement


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Bio-MA<br>Calcium silicate cement containing calcium chloride accelerator | Other: Calcium silicate cement<br>* Calcium silicate cement for using in endodontic treatments i.e. pulpotomy, orthograde MTA apical barrier, root perforation repair, and endodontic microsurgery.<br>|
| Other: ProRoot MTA<br>Calcium silicate cement without calcium chloride accelerator | Other: Calcium silicate cement<br>* Calcium silicate cement for using in endodontic treatments i.e. pulpotomy, orthograde MTA apical barrier, root perforation repair, and endodontic microsurgery.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healed rate | No clinical sign and symptoms and periapical area in radiograph is normal. Describe in percentage. | At least 1 year recall | 
| Healing rate | No clinical sign and symptoms and periapical lesion in radiograph is reduce in size. Describe in percentage. | At least 1 year recall | 
| Disease rate | Clinical sign and symptoms is present and/or periapical lesion in radiograph is unchange or enlarge. Describe in percentage. | At least 1 year recall |