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

Periapical Lesions Clinical Trial

Official title:

The Effects of BioCeramic Sealer With Single Cone Technique on the Healing of Periapical Lesions: A Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06400030
• Other study ID #: UDDS-Endo-1-2024
• Status: Completed
• Phase: N/A
• Start date: June 22, 2020
• Est. completion date: April 15, 2023

Study information

• Verified date: May 2024
• Source: Damascus University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Periapical lesions is considered as the most common symptoms associated with infected root canals.

Recently, the BioCeramic sealer has been considered one of the most common endodontic sealer that possess antibacterial properties, so it can have an effective role in the healing of periapical lesions, as well as its ability to prevent periapical leakage due to its attachment to the dentinal walls and gutta-percha cones.

This study will evaluate the effect of BioCeramic sealer on the healing of periapical lesions and the changes of the dimensions of the lesions.

Root canal obturation with gutta-percha cones will be applied in the two groups: The control group will receive the AH Plus with lateral condensation technique, and the experimental group will receive BioCeramic sealer with single cone technique.

CBCT radiographs will be gotten before and after one year of the treatment to evaluate the periapical lesion dimensions changes.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: April 15, 2023
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• Root caries.

• Root fractures or resorption.

• Signs of occlusal trauma on the treated tooth.

• Internal or external resorption.

• Active periodontal disease.

• Pregnancy or lactation.

Related Conditions & MeSH terms

• Periapical Lesions

Intervention

Procedure:
• Root canal treatment with AH Plus sealer
- 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.
• Root canal treatment with BioCeramic sealer
- 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.

Locations

Country	Name	City	State
Syrian Arab Republic	Damascus University	Damascus

Sponsors (1)

Lead Sponsor	Collaborator
Damascus University

Country where clinical trial is conducted

Syrian Arab Republic, 

References & Publications (5)

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. Erratum In: J Endod. 2018 Jul;44(7):1199. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in the presence of edema	The detection of the edema will be performed using clinical examination (palpating the buccal tissues of the treated tooth).; Time Frame: before, after six months, and after one year of the treatment (root canal obturation)	before, after six months, and one year of the treatment (root canal obturation)