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

Overview

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.

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

Study Type

• Study Type: Interventional
• Study Design
  • Allocation: Randomized
  • Intervention Model: Parallel Assignment
  • Primary Purpose: Treatment
  • Masking: Double (Participant, Outcomes Assessor)
• Study Primary Completion Date: December 31, 2022

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.''

Interventions

• 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.

Arms, Groups and Cohorts

• Other: Bio-MA
  • Calcium silicate cement containing calcium chloride accelerator
• Other: ProRoot MTA
  • Calcium silicate cement without calcium chloride accelerator

Clinical Trial Outcome Measures

Primary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 10 Years

Maximum Age: 65 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

• Lead Sponsor
  • Mahidol University
• Provider of Information About this Clinical Study
  • Sponsor
• Overall Official(s)
  • Supachai Sutimuntanakul, TBOD, Study Director, Mahidol University
• Overall Contact(s)
  • Danuchit Banomyong, Ph.D., 022007622, danuchit.ban@mahidol.ac.th