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

Endodontic Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04243993
• Other study ID #: MU-DT/PY-IRB 2016/052.0310
• Status: Recruiting
• Phase: N/A
• Start date: July 1, 2017
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2020
• Source: Mahidol University
• Contact: Danuchit Banomyong, Ph.D.
• Phone: 022007622
• Email: danuchit.ban[@]mahidol.ac.th
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.''

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Clinical Outcome
• Dental Pulp Diseases
• Endodontic Disease

Intervention

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.

Locations

Country	Name	City	State
Thailand	Nuttida Tungsuksomboon	Bangkok

Sponsors (1)

Lead Sponsor	Collaborator
Mahidol University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Healed rate	No clinical sign and symptoms and periapical area in radiograph is normal. Describe in percentage.	At least 1 year recall
Primary	Healing rate	No clinical sign and symptoms and periapical lesion in radiograph is reduce in size. Describe in percentage.	At least 1 year recall
Primary	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