Clinical OutcomeNCT04243993
Clinical Outcomes of Bio-MA and ProRoot MTA in Endodontic Treatment
A study testing Calcium silicate cement in people with Clinical Outcome and Endodontic Disease, run by Mahidol University at 1 site in Thailand.
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. Read more about this study
- Who is it for?
- Ages 10 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Clinical Outcome, Endodontic Disease
- What is being tested?
- Calcium silicate cement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jul 2017to 31 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Teeth treated with pulpotomy, orthograde MTA apical barrier, root perforation repair or endodontic microsurgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Nuttida Tungsuksomboon
Bangkok, 10400
Nuttida Tungsuksomboon, DDS, 022007622, ntd_tssb@hotmail.com
About this study
Official title: Clinical Outcomes of Bio-MA and ProRoot MTA in Non-surgical and Surgical Endodontic Treatment: a Randomized Controlled Clinical Trial
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.
Read the 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.''
- Conditions
- Clinical Outcome, Endodontic Disease
- Being tested
- Calcium silicate cement
- Medical subject headings
- Dental Pulp Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Calcium silicate cementOther
Calcium silicate cement for using in endodontic treatments i.e. pulpotomy, orthograde MTA apical barrier, root perforation repair, and endodontic microsurgery.
| Study group | Role | What they receive |
|---|---|---|
| Bio-MA | Other | Calcium silicate cement containing calcium chloride accelerator Receives: Other: Calcium silicate cement |
| ProRoot MTA | Other | Calcium silicate cement without calcium chloride accelerator Receives: Other: Calcium silicate cement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healed rate
No clinical sign and symptoms and periapical area in radiograph is normal. Describe in percentage.
Measured: At least 1 year recall
Healing rate
No clinical sign and symptoms and periapical lesion in radiograph is reduce in size. Describe in percentage.
Measured: 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.
Measured: At least 1 year recall
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2020
- Study start1 Jul 2017
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Clinical OutcomeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Supachai Sutimuntanakul, TBOD, Study director, Mahidol University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04243993
- Sponsor's protocol ID
- MU-DT/PY-IRB 2016/052.0310
- Status last verified
- Jan 2020
- First submitted
- 24 Dec 2019
- Last updated
- 28 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes of Bio-MA and ProRoot MTA in Non-surgical and Surgical Endodontic Treatment: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT04243993
- Acronym / sponsor ID
- MU-DT/PY-IRB 2016/052.0310
- Conditions
- Clinical Outcome, Endodontic Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 28 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bio-MA | Other | Other: Calcium silicate cementCalcium silicate cement containing calcium chloride accelerator |
| ProRoot MTA | Other | Other: Calcium silicate cementCalcium silicate cement without calcium chloride accelerator |
Who may qualify
- Ages
- 10 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Teeth treated with pulpotomy, orthograde MTA apical barrier, root perforation repair or endodontic microsurgery
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Calcium silicate cementCalcium silicate cement for using in endodontic treatments i.e. pulpotomy, orthograde MTA apical barrier, root perforation repair, and endodontic microsurgery. | Other | Bio-MA, ProRoot MTA |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Supachai Sutimuntanakul, TBOD study director
Mahidol University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Calcium silicate cement in people with Clinical Outcome and Endodontic Disease, run by Mahidol University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Danuchit Banomyong, Ph.D. (022007622, danuchit.ban@mahidol.ac.th), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healed rate (time frame: At least 1 year recall). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2020.