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

Primary Purpose

Endodontic Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ortho MTA cement
GP and AH Plus sealer
Sponsored by
National University Hospital, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Endodontic Disease

Eligibility Criteria

21 Years - 95 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Experimental

    Arm Label

    GP and AH Plus sealer

    Ortho MTA

    Arm Description

    Root canal obturation using gutta percha and AH Plus® bioceramic sealer.

    Root canal obturation using Ortho MTA cement.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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.

    Full Information

    First Posted
    July 12, 2023
    Last Updated
    August 2, 2023
    Sponsor
    National University Hospital, Singapore
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05984940
    Brief Title
    Treatment Outcome of Ortho MTA (BioMTA®) Cement vs AH Plus® Bioceramic Sealer (Dentsply).
    Official Title
    Clinical Outcome of Root Canal Treatment With Ortho MTA (BioMTA®) Cement and AH Plus® Bioceramic Sealer (Dentsply). A Randomized Controlled Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 2023 (Anticipated)
    Primary Completion Date
    December 31, 2024 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    National University Hospital, Singapore

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.
    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Endodontic Disease

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    GP and AH Plus sealer
    Arm Type
    Active Comparator
    Arm Description
    Root canal obturation using gutta percha and AH Plus® bioceramic sealer.
    Arm Title
    Ortho MTA
    Arm Type
    Experimental
    Arm Description
    Root canal obturation using Ortho MTA cement.
    Intervention Type
    Device
    Intervention Name(s)
    Ortho MTA cement
    Intervention Description
    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.
    Intervention Type
    Device
    Intervention Name(s)
    GP and AH Plus sealer
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    Primary Objectives (Change in baseline periapical lesion size at 6 month and 12 month)
    Description
    Change in baseline periapical lesion size at 6 month and 12 month
    Time Frame
    6, 12 months
    Secondary Outcome Measure Information:
    Title
    Secondary Objectives (Change in baseline post-operative pain at Day 1, Day 3 and Day 7 post treatment)
    Description
    Change in baseline post-operative pain at Day 1, Day 3 and Day 7 post treatment.
    Time Frame
    1, 3, 7 days

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    21 Years
    Maximum Age & Unit of Time
    95 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Siyi Choo
    Phone
    +65 82223285
    Email
    choosiyi@nus.edu.sg

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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