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

NCT ID: NCT04243993

Last Updated: 2020-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-01

Study Completion Date

2024-12-31

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.''

Conditions

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Clinical Outcome Endodontic Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Bio-MA

Calcium silicate cement containing calcium chloride accelerator

Group Type OTHER

Calcium silicate cement

Intervention Type OTHER

Calcium silicate cement for using in endodontic treatments i.e. pulpotomy, orthograde MTA apical barrier, root perforation repair, and endodontic microsurgery.

ProRoot MTA

Calcium silicate cement without calcium chloride accelerator

Group Type OTHER

Calcium silicate cement

Intervention Type OTHER

Calcium silicate cement for using in endodontic treatments i.e. pulpotomy, orthograde MTA apical barrier, root perforation repair, and endodontic microsurgery.

Interventions

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Calcium silicate cement

Calcium silicate cement for using in endodontic treatments i.e. pulpotomy, orthograde MTA apical barrier, root perforation repair, and endodontic microsurgery.

Intervention Type OTHER

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
Minimum Eligible Age

10 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Supachai Sutimuntanakul, TBOD

Role: STUDY_DIRECTOR

Mahidol University

Locations

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Nuttida Tungsuksomboon

Bangkok, , Thailand

Site Status RECRUITING

Countries

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Thailand

Central Contacts

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Danuchit Banomyong, Ph.D.

Role: CONTACT

022007622

Facility Contacts

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Nuttida Tungsuksomboon, DDS

Role: primary

022007622

Other Identifiers

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MU-DT/PY-IRB 2016/052.0310

Identifier Type: -

Identifier Source: org_study_id

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