NCT04243993

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2017

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2017

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

December 24, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

January 28, 2020

Status Verified

January 1, 2020

Enrollment Period

5.5 years

First QC Date

December 24, 2019

Last Update Submit

January 26, 2020

Conditions

Clinical OutcomeEndodontic Disease

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (2)

Bio-MA

OTHER

Calcium silicate cement containing calcium chloride accelerator

Other: Calcium silicate cement

ProRoot MTA

OTHER

Calcium silicate cement without calcium chloride accelerator

Other: Calcium silicate cement

Interventions

Calcium silicate cementOTHER

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

Bio-MAProRoot MTA

Eligibility Criteria

Age10 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Teeth treated with pulpotomy, orthograde MTA apical barrier, root perforation repair or endodontic microsurgery

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nuttida Tungsuksomboon

Bangkok, 10400, Thailand

RECRUITING

MeSH Terms

Conditions

Dental Pulp Diseases

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Study Officials

  • Supachai Sutimuntanakul, TBOD

    Mahidol University

    STUDY DIRECTOR

Central Study Contacts

Danuchit Banomyong, Ph.D.

CONTACT

022007622danuchit.ban@mahidol.ac.th

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 24, 2019

First Posted

January 28, 2020

Study Start

July 1, 2017

Primary Completion

December 31, 2022

Study Completion

December 31, 2024

Last Updated

January 28, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

TH(1)