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

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ClinicalTrials.gov Identifier: NCT05984940
Recruitment Status : Not yet recruiting
First Posted : August 9, 2023
Last Update Posted : August 9, 2023
Sponsor:
Information provided by (Responsible Party):
National University Hospital, Singapore

Study Description
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Brief 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. 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.


Condition or disease Intervention/treatment Phase
Endodontic Disease Device: Ortho MTA cement Device: GP and AH Plus sealer Not Applicable

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).

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Outcome of Root Canal Treatment With Ortho MTA (BioMTA®) Cement and AH Plus® Bioceramic Sealer (Dentsply). A Randomized Controlled Trial.
Estimated Study Start Date : August 2023
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2025
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: GP and AH Plus sealer
Root canal obturation using gutta percha and AH Plus® bioceramic sealer.
 Device: GP and AH Plus sealer
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.
Experimental: Ortho MTA
Root canal obturation using Ortho MTA cement.
 Device: Ortho MTA cement
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.


Outcome Measures
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Primary Outcome Measures :
  1. Primary Objectives (Change in baseline periapical lesion size at 6 month and 12 month) [ Time Frame: 6, 12 months ]
    Change in baseline periapical lesion size at 6 month and 12 month


Secondary Outcome Measures :
  1. Secondary Objectives (Change in baseline post-operative pain at Day 1, Day 3 and Day 7 post treatment) [ Time Frame: 1, 3, 7 days ]
    Change in baseline post-operative pain at Day 1, Day 3 and Day 7 post treatment.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05984940


Contacts
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Contact: Siyi Choo +65 82223285 choosiyi@nus.edu.sg

Sponsors and Collaborators
National University Hospital, Singapore
More Information
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Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT05984940    
Other Study ID Numbers: 2023/00168
First Posted: August 9, 2023    Key Record Dates
Last Update Posted: August 9, 2023
Last Verified: July 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Dental Pulp Diseases
Tooth Diseases
Stomatognathic Diseases