Clinical trial NCT06400030: A Comparison Between Two Types of Sealers in the Healing of Periapical Lesions
Official title: The Effects of BioCeramic Sealer With Single Cone Technique on the Healing of Periapical Lesions: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periapical Lesions
Keywords: Single Cone Technique
Lateral Condensation
BioCeramic-based Sealer
AH Plus
Lead sponsor: Damascus University
Sponsor class: OTHER
First posted: 2024-05-06
Enrollment: 41
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in the periapical lesion diameter
timeFrame: before and after one year of the treatment (root canal obturation)
Secondary outcomes:
measure: Change in the presence of edema
timeFrame: before, after six months, and one year of the treatment (root canal obturation)
Other outcomes:
Locations:
city: Damascus
country: Syrian Arab Republic
facility: Damascus University
Study officials:
References:
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.
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.
citation: 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.
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.
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.