The Frequency Of Sodium Hypochlorite Extrusion During Endodontic Treatments

Sponsor
Bulent Ecevit University (Other)
Overall Status
Unknown status
CT.gov ID
NCT04262362
Collaborator
(none)
1,000
1
9.3
107.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Root canal treatment

Detailed 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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Other
Time Perspective:
Prospective
Official Title:
The Frequency Of Sodium Hypochlorite Extrusion During Endodontic Treatments: A Clinical Study
Actual Study Start Date :
Dec 5, 2019
Anticipated Primary Completion Date :
Sep 14, 2020
Anticipated Study Completion Date :
Sep 14, 2020

Outcome Measures

Primary Outcome Measures

  1. Incidence of pain and symptoms [During treatment]

    pain or other symptoms due to sodium hypochlorite extrusion

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Requirement of root canal treatment
Exclusion Criteria:
  • Sodium hypochlorite allergy

  • Immature tooth

  • root resorption

Contacts and Locations

Locations

Site City State Country Postal Code
1 Bülent Ecevit University, Faculty of Dentistry Zonguldak Turkey 67600

Sponsors and Collaborators

  • Bulent Ecevit University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mustafa Murat Koçak, Associate professor, Bulent Ecevit University
ClinicalTrials.gov Identifier:
NCT04262362
Other Study ID Numbers:
  • Bülent Ecevit universi
First Posted:
Feb 10, 2020
Last Update Posted:
Feb 10, 2020
Last Verified:
Feb 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 10, 2020