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NCT Number: NCT06400030

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

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.

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Key information

Conditions

Periapical Lesions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Damascus University

Damascus, Syria

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

Sponsors and collaborators

Lead sponsor

Damascus University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2022
Study completion
2023
First posted
May 6, 2024
Registry last updated
May 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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