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

Not Applicable

Recruiting

• Conditions: Endodontic Disease; Clinical Outcome
• Interventions: Other: Calcium silicate cement

• Registration Number: NCT04243993
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2019-12-24
• Status Verified: 2020-01
• Study First Submitted QC: 2020-01-26
• Last Update Submitted: 2020-01-26
• Study First Posted: 2020-01-28
• Last Update Posted: 2020-01-28
• Primary Completion: 2022-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Bio-MA	Calcium silicate cement	Calcium silicate cement containing calcium chloride accelerator
ProRoot MTA	Calcium silicate cement	Calcium silicate cement without calcium chloride accelerator

Primary Outcome Measures

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

Trial Locations

Locations (1)

Nuttida Tungsuksomboon; 🇹🇭 Bangkok, Thailand