A Comparison Between Two Types of Sealers in the Healing of Periapical Lesions

NCT06400030 | Completed DMC

• 1 other identifier: UDDS-Endo-1-2024
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study will evaluate the effect of BioCeramic sealer with single cone compared with the control group treated with AH Plus with lateral condensation in root canal obturation on the healing of periapical lesions. The study sample will consist of 41 patients with 65 teeth with clear periapical lesions. Root canal obturation will be applied for all patients. BioCeramic sealer will be applied for the experimental group only. The changes of the dimensions of the periapical lesion will be assessed using CBCT radiographs; pre- and post- treatment changes for each group will be evaluated individually.

Conditions

Periapical Lesions

Keywords

Single Cone Technique; Lateral Condensation; BioCeramic-based Sealer; AH Plus

Outcome Measures

Primary Outcomes (1)

• Change in the periapical lesion diameter

  This diameter of the periapical lesions is going to be measured on a CBCT image. Initially, the sections of the periapical lesions will be evaluated in the three planes (sagittal, coronal, and axial). The section that contains the largest area of the lesion in each studied plane, will be used for measurement. * If the shape of periapical lesion is circular, the periapical diameter would be taken (at this plane) relying on the scale in the program accompanying the radiograph (CBCT). * If the shape of periapical lesion is not circular, the largest and smallest diameter of the lesion will be taken (at this plane) depending on the scale in the program accompanying the CBCT image, then the mean diameter will be calculated by collecting the previous two diameter and dividing them by 2. Ultimately, the three diameters of the lesion (taken at the three planes) are collected and the total is divided into 3 to obtain the mean diameter of the lesion.

  before and after one year of the treatment (root canal obturation)

Secondary Outcomes (1)

• Change in the presence of edema

  before, after six months, and one year of the treatment (root canal obturation)

Study Arms (2)

AH Plus sealer Group (Control Group)

OTHER

in this group, root canal system was filled with AH Plus sealer in conjunction with lateral condensation.

Procedure: Root canal treatment with AH Plus sealer

BioCeramic Sealer Group (Experimental Group

EXPERIMENTAL

in this group, root canal system was filled with BioCeramic-based sealer in conjunction with single gutta-percha cone.

Procedure: Root canal treatment with BioCeramic sealer

Interventions

Root canal treatment with AH Plus sealer PROCEDURE

\- AH Plus sealer Group: the base and accelerator of AH Plus Sealer was mixed, then the walls of the canal were coated with the AH Plus sealer using K-File, then lateral condensation was performed through a number of gutta-percha cones.

AH Plus sealer Group (Control Group)

Root canal treatment with BioCeramic sealer PROCEDURE

\- BioCeramic Sealer Group: the canals in this group were filled using BioCeramic-based sealer and a single gutta-percha cone, and gently insert it into the root canal to the preselected working length without applying pressure.

BioCeramic Sealer Group (Experimental Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• One maxillary anterior tooth with a clear periapical lesion at least.
• Normal anatomic features and straight or slightly curved roots.
• The treated teeth must have complete roots and a closed apex.
• The ability to isolate the teeth with a rubber dam and restore them.
• Good oral hygiene.
• Good systemic health.

You may not qualify if:

• Root caries.
• Root fractures or resorption.
• Signs of occlusal trauma on the treated tooth.
• Internal or external resorption.
• Active periodontal disease.
• Pregnancy or lactation.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Damascus University

Damascus, Syria

Location

Related Publications (5)

• Zavattini A, Knight A, Foschi F, Mannocci F. Outcome of Root Canal Treatments Using a New Calcium Silicate Root Canal Sealer: A Non-Randomized Clinical Trial. J Clin Med. 2020 Mar 13;9(3):782. doi: 10.3390/jcm9030782.

  PMID: 32183124 BACKGROUND

• Martins JFB, Scheeren B, van der Waal SV. The Effect of Unintentional AH-Plus Sealer Extrusion on Resolution of Apical Periodontitis After Root Canal Treatment and Retreatment-A Retrospective Case-control Study. J Endod. 2023 Oct;49(10):1262-1268. doi: 10.1016/j.joen.2023.07.021. Epub 2023 Jul 28.

  PMID: 37516239 BACKGROUND

• Chybowski EA, Glickman GN, Patel Y, Fleury A, Solomon E, He J. Clinical Outcome of Non-Surgical Root Canal Treatment Using a Single-cone Technique with Endosequence Bioceramic Sealer: A Retrospective Analysis. J Endod. 2018 Jun;44(6):941-945. doi: 10.1016/j.joen.2018.02.019. Epub 2018 Mar 29.

  PMID: 29606401 BACKGROUND

• Khandelwal A, Janani K, Teja K, Jose J, Battineni G, Riccitiello F, Valletta A, Palanivelu A, Spagnuolo G. Periapical Healing following Root Canal Treatment Using Different Endodontic Sealers: A Systematic Review. Biomed Res Int. 2022 Jul 8;2022:3569281. doi: 10.1155/2022/3569281. eCollection 2022.

  PMID: 35845966 BACKGROUND

• Del Fabbro M, Corbella S, Sequeira-Byron P, Tsesis I, Rosen E, Lolato A, Taschieri S. Endodontic procedures for retreatment of periapical lesions. Cochrane Database Syst Rev. 2016 Oct 19;10(10):CD005511. doi: 10.1002/14651858.CD005511.pub3.

  PMID: 27759881 BACKGROUND

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: April 20, 2024
• First Posted: May 6, 2024
• Study Start: June 22, 2020
• Primary Completion: March 1, 2022
• Study Completion: April 15, 2023
• Last Updated: May 6, 2024

Record last verified: 2024-05

Locations

SY (1)