The Frequency Of Sodium Hypochlorite Extrusion During Endodontic Treatments

Pain, Acute Clinical Trial

Official title:

The Frequency Of Sodium Hypochlorite Extrusion During Endodontic Treatments: A Clinical Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04262362
• Other study ID #: Bülent Ecevit universi
• Status: Recruiting
• Start date: December 5, 2019
• Est. completion date: September 14, 2020

Study information

• Verified date: February 2020
• Source: Bulent Ecevit University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Sodium hypochlorite is a commonly used irrigation agent. However, the solution may extrude beyond the apex of tooth and cause pain during the treatment.The aim of this prospective observational investigation is to determinate the frequency of the extrusion of sodtium hypochlorite in endodontically treated teeth.

Description:

Sodium hypochlorite (NaOCl) is a gold standard irrigation solution that has antimicrobial and tissue solvent effect. Until now, there is no other alternative that provides its activity characteristics. Although it represents many advantages, and it is usually considered safe, some cases of mishap and systematic reviews about case reports of NaOCl accident especially during endodontic procedures, have been reported in the literature. NaOCl may lead potentially very damaging injuring results with acute pain, swelling, hemolysis, ulceration, inhibition of neutrophil migration, endothelial and fibroblast cell damage, nerve weakness or damage, trismus and tissue necrosis if it overflows the periapical area.

The aim of this prospective observational investigation is to determinate the frequency of the extrusion in endodontically treated teeth.

The patients who applied to the clinic for dental treatment will be identified as having root canal treatment indication for at least one tooth. After the detailed medical and dental history will be obtained, the written consent form was taken from the patients who wanted to participate in the study. Age, gender, medical history, preoperative pain and pulpal status, having any periapical radiolusency of the related tooth will be recorded and root canal treatment will be performed according to routine procedures. After treatment, the code of tooth according to FDI classification, number of root, apical diameter, volume and concentration of irrigation solution will be recorded.

Routine treatment follow-up will be performed in patients who has no NaOCl overflow from the root during procedure. The patients with NaOCl overflow during the treatment process, appropriate treatment will be planned and followed up until symptoms regress.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 14, 2020
• Est. primary completion date: September 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Requirement of root canal treatment

Exclusion Criteria:

• Sodium hypochlorite allergy

• Immature tooth

• root resorption

Related Conditions & MeSH terms

• Acute Pain
• Dental Pulp Necrosis
• Necrotic Pulp
• Pain, Acute

Intervention

Procedure:
• Root canal treatment
Incidence of pain that may occur due to sodium hypochlorite extrusion

Locations

Country	Name	City	State
Turkey	Bülent Ecevit University, Faculty of Dentistry	Zonguldak

Sponsors (1)

Lead Sponsor	Collaborator
Bulent Ecevit University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of pain and symptoms	pain or other symptoms due to sodium hypochlorite extrusion	During treatment