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

NCT05984940 | Unknown

• 1 other identifier: 2023/00168
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Endodontic Disease

Outcome Measures

Primary Outcomes (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

  6, 12 months

Secondary Outcomes (1)

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

  1, 3, 7 days

Study Arms (2)

GP and AH Plus sealer

ACTIVE COMPARATOR

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

Device: GP and AH Plus sealer

Ortho MTA

EXPERIMENTAL

Root canal obturation using Ortho MTA cement.

Device: Ortho MTA cement

Interventions

Ortho MTA cement DEVICE

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.

Ortho MTA

GP and AH Plus sealer DEVICE

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.

GP and AH Plus sealer

Eligibility Criteria

• Age: 21 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• National University Hospital, Singapore: lead

Study Sites (1)

National University Hospital, Singapore

Singapore, 119074, Singapore

RECRUITING

MeSH Terms

Conditions

Dental Pulp Diseases

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Central Study Contacts

Siyi Choo

CONTACT

+65 82223285; choosiyi@nus.edu.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2023
• First Posted: August 9, 2023
• Study Start: September 21, 2023
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2025
• Last Updated: August 28, 2024

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)