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

May 1, 2024 updated by: Damascus University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

41

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: AH Plus sealer Group (Control Group)
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
- 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.
Experimental: BioCeramic Sealer Group (Experimental Group
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
- 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the periapical lesion diameter
Time Frame: before and after one year of the treatment (root canal obturation)

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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the presence of edema
Time Frame: before, after six months, and one year of the treatment (root canal obturation)

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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Damascus University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 22, 2020

Primary Completion (Actual)

March 1, 2022

Study Completion (Actual)

April 15, 2023

Study Registration Dates

First Submitted

April 20, 2024

First Submitted That Met QC Criteria

May 1, 2024

First Posted (Actual)

May 6, 2024

Study Record Updates

Last Update Posted (Actual)

May 6, 2024

Last Update Submitted That Met QC Criteria

May 1, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • UDDS-Endo-1-2024

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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