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Endodontic DiseaseNCT05984940

Treatment Outcome of Ortho MTA (BioMTA®) Cement vs AH Plus® Bioceramic Sealer (Dentsply).

A study testing Ortho MTA cement and GP and AH Plus sealer in people with Endodontic Disease, run by National University Hospital, Singapore at 1 site in Singapore.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The use of bioceramics materials as root canal fillings in endodontics is gaining traction due to their excellent biocompatibility, antibacterial and sealing abilities. They are dispensed in the form of sealers and cements to be used with gutta-percha or mixed with liquids to form a paste. Read more about this study

Who is it for?
Ages 21 to 95 years
Conditions the study is for
Endodontic Disease
What is being tested?
Ortho MTA cement and GP and AH Plus sealer
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
1 siteSingapore
Study dates
21 Sep 2023to 31 Dec 2025
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 21 to 95 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • A preoperative periapical radiograph will be required for diagnosis.
  • Subjects at least 21 years old to 95 years old.
  • Medically healthy
  • In a patient with multiple teeth requiring root canal treatment, only 1 tooth from each side will be included and selected at random.
  • Tooth requiring root canal treatment presenting with periapical radiolucency.

Who cannot join

  • Patients below 21 years old.
  • Pregnant women.
  • Patients with autoimmune disease and uncontrolled diabetes.
  • Teeth with periodontal probing depth 5mm or more.
  • Incomplete root formation that is detected radiographically.
  • Cracked teeth.
  • Teeth are deemed to have poor restorative prognosis.
  • Teeth with adjacent teeth on the same side that require root canal treatment.

Trial locations and contacts

1 site in 1 country.

Singapore1 site, 1 recruiting
  • National University Hospital, Singapore

    Singapore, 119074

    Victoria Yu, PhD, 67725340, victoria@nus.edu.sg

    Recruiting

Other trials in Singapore

About this study

Official title: Clinical Outcome of Root Canal Treatment With Ortho MTA (BioMTA®) Cement and AH Plus® Bioceramic Sealer (Dentsply). A Randomized Controlled Trial.

The use of bioceramics materials as root canal fillings in endodontics is gaining traction due to their excellent biocompatibility, antibacterial and sealing abilities. They are dispensed in the form of sealers and cements to be used with gutta-percha or mixed with liquids to form a paste. Recently, Ortho MTA (BioMTA®) cement is clinically available as a root filling material, without the need for gutta-percha. The purpose of this randomized controlled clinical trial is to compare clinical outcome between the novel Ortho MTA (BioMTA®) and the conventional gutta-percha with bioceramic sealer, when used as obturating materials in root canal treatment. This research aims to compare the healing outcome of infected teeth treated by root canal treatment and root-filled using MTA cement (Ortho MTA, BioMTA® Seoul Korea) or bioceramic sealer (AH Plus® Bioceramic Sealer (Dentsply).

The sealer can be used alone or in combination with gutta-percha obturating cones, injected gutta-percha material or core-carriers master cones. In vitro studies have demonstrated the capability of MTA to generate hydroxyapatite precipitates that penetrate into dentinal tubules.

Read the detailed description

The use of bioceramics materials as root canal fillings in endodontics is gaining traction due to their excellent biocompatibility, antibacterial and sealing abilities. They are dispensed in the form of sealers and cements to be used with gutta-percha or mixed with liquids to form a paste.

In the sealer form, comparisons have been made between bioceramic and conventional resin-based sealers to study post-operative pain, cytocompatibility and bioactivity potential and treatment outcomes. In the cement form (MTA and Biodentine), they are largely used in apexification, regeneration endodontics, perforation repairs and apical surgeries. Recently, Ortho MTA (BioMTA®) cement is clinically available as a root filling material, without the need for gutta-percha. There are currently no systematic evaluations of this material therefore the purpose of this randomized controlled clinical trial is to compare clinical outcome between the novel Ortho MTA (BioMTA®) and the conventional gutta-percha with bioceramic sealer, when used as obturating materials in root canal treatment.

Mineralized Trioxide Aggregate (MTA) is a powder of fine trioxides (tricalcium oxides, silicon oxide, bismuth oxide) and hydrophilic particles (tricalcium silicate and tricalcium aluminate). It has good biocompatibility, antibacterial, dimensionally stable, provides hermetic seal against leakage and capable of stimulating healing and osteogenesis (bioactive). It is usually mixed with distilled water or saline to form colloidal gel with pH 12.5 and solidifies in 3-4 hours. The release of calcium hydroxide during setting are responsible for the high alkalinity, antibacterial and bioactivity.

Ortho MTA (BioMTA®) is an orthograde root canal filling material that was synthesized by mineral trioxide aggregate's active ingredient through Bio-ceramic manufacturing process. It was formulated to meet the ideal requirements of root canal filling material necessary for a clinically effective root canal treatment on cases of file separation, cracked tooth, severely infected canal, and treatment of acute apical abscess. It is packaged as powder in a vial and mixed with distilled water where setting begins and continues in vivo.

AH Plus® Bioceramic Sealer is a root canal sealer conforming to ISO 6876, in a pre-loaded syringe that does not require any pre-mixing and is set by absorbing moisture from the root canal environment. The sealer can be used either alone or in combination with gutta-percha obturating cones, injected gutta-percha material or core-carriers master cones.

Root canal treatment often uses gutta-percha and sealers to provide 3-dimensional hermetic seal of a cleaned and disinfected canal. To date, studies exploring root canal treatment with bioceramic and resin-based sealers have showed comparable results. At the same time, MTA has been widely used over the past 30 years in a variety of endodontic treatment targeted at restoring compromised teeth, including as apical barriers/seals for immature tooth with open apices, in root end surgeries root perforation repairs, preservation of the carious vital pulp and revitalization of infected immature teeth. Especially among teeth weakened by infection, the concept of a "monoblock" of root canal filling that is bonded to dentine to strengthen the tooth, is attractive. While clinical research into the monoblock root filling created by conventional gutta-percha and sealer has failed to show significant advantage, in vitro studies have demonstrated the capability of MTA to generate hydroxyapatite precipitates that penetrate into dentinal tubules, taking the technology one step closer to the monoblock concept. Hence, the purpose of this research is to compare the healing outcome of infected teeth treated by root canal treatment and root-filled using MTA cement (Ortho MTA, BioMTA® Seoul Korea) or bioceramic sealer (AH Plus® Bioceramic Sealer (Dentsply).

Being tested
Ortho MTA cement, GP and AH Plus sealer
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.

  • Ortho MTA cementDevice

    Ortho MTA has a fine granularity for only 2 microns. It penetrates into dental tubules and fuses itself to the surface where it is applied. In addition, it prevents micro-leakage by forming an interfacing layer of hydroxyapatite (Hap) between the OrthoMTA and the canal wall.

  • GP and AH Plus sealerDevice

    AH Plus Sealer is a calcium silicate-based root canal sealer. Tricalcium Silicate interacts with body fluids to release calcium and hydroxide ions that promote hydroxyapatite (HA) formation.

Study groups in NCT05984940
Study groupRoleWhat they receive
GP and AH Plus sealerActive comparatorRoot canal obturation using gutta percha and AH Plus® bioceramic sealer.
Receives: Device: GP and AH Plus sealer
Ortho MTAExperimentalRoot canal obturation using Ortho MTA cement.
Receives: Device: Ortho MTA cement

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Primary Objectives (Change in baseline periapical lesion size at 6 month and 12 month)

    Change in baseline periapical lesion size at 6 month and 12 month

    Measured: 6, 12 months

Secondary outcomes (1)
  1. Secondary Objectives (Change in baseline post-operative pain at Day 1, Day 3 and Day 7 post treatment)

    Change in baseline post-operative pain at Day 1, Day 3 and Day 7 post treatment.

    Measured: 1, 3, 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Aug 2023
  2. Study start21 Sep 2023
  3. Primary completion31 Dec 2024 (estimated)
  4. Study completion31 Dec 2025 (estimated)

Resources

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
None (open label)
Enrolment
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05984940
Sponsor's protocol ID
2023/00168
Other IDs
2023
Status last verified
Sep 2023
First submitted
12 Jul 2023
Last updated
28 Aug 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Ortho MTA cement and GP and AH Plus sealer in people with Endodontic Disease, run by National University Hospital, Singapore at 1 site in Singapore.

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 5 inclusion and 8 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 Aug 2024. 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 Singapore. 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 Siyi Choo (+65 82223285, choosiyi@nus.edu.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Objectives (Change in baseline periapical lesion size at 6 month and 12 month) (time frame: 6, 12 months). 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 Aug 2024.

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