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

Endodontic Disease Clinical Trial

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

Status Not yet recruiting

Clinical 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. 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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Dental Pulp Diseases
• Endodontic Disease

• NCT number: NCT05984940
• Study type: Interventional
• Source: National University Hospital, Singapore
• Contact: Siyi Choo
• Phone: +65 82223285
• Email: choosiyi@nus.edu.sg
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 2023
• Completion date: December 31, 2025