The Effect of Irrigant Types Used During Endodontic Treatment on Postoperative Pain

NCT04190355 | Unknown

• 1 other identifier: 11/29.05.2019
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

Chemomechanical preparation of the root canal system potentially results in extrusion of debris into the periradicular tissues. This debris is composed of hard tissue (dentin), soft tissue (inflamed or necrotic pulp tissues) and microbiota. Furthermore, the chemical adjuncts used during root canal disinfection may also extrude into the periradicular tissues. Extrusion of such materials results in postoperative pain, inflammation and and flare-up. There is evidence to demonstrate that most instrumentation techniques cause extrusion of debris, and that, severity of the inflammatory response depends on the amount of debris extrusion. Several factors may influence the debris extrusion during root canal preparation, including the instrument design, technique of use and irrigating agent used during preparation.Sodium hypochlorite (NaOCl) is the most commonly used root canal irrigant during root canal treatment. However, its cytotoxic effects when extruded into the periapical tissues is an issue of clinical concern. Thus, there has been a search for more biocompatible irrigants. One potential option, which has not been explored in detail, is the use of NaOCl, but in a gel form rather than a solution. NaOCl gel has similar effects on the dentin, as the solution form. Interestingly, greater dentinal tubule penetration depth has been reported for the gel form, compared to the solution. Previous studies have evaluated the effect of preparation techniques, the number of appointments and intracranial medicaments on postoperative pain during Endodontics treatment. There is no study evaluating the effect of different irritant type on PP. Therefore, this study will be evaluated the effect of different irritant type (gel or solution form of NaOCI) on postoperative pain.

Conditions

Postoperative Pain

Keywords

Root canal; irrigation; irrigant type; postoperative pain

Outcome Measures

Primary Outcomes (1)

• VAS scala

  PP will be assessed with a VAS after endodontic treatment. The VAS consisted of a 100-mm hor- izontal ruler with marks every 10 mm and no numbers except a 0 at the first part of the scale and a 10 in the last part of the scale.

  up to 7 days

Study Arms (2)

5.25% NaOCl solution

ACTIVE COMPARATOR

5.25% NaOCl solution will be used as irrigation solution at every file change during root canal preperation

Other: Irrigant type; Drug: 5.25% NaOCl

5.25% Cloraxid gel/ distilled water

ACTIVE COMPARATOR

5.25% Cloraxid gel/ distilled water will be used as irrigation solution at every file change during root canal preperation

Drug: 5.25% Cloraxid gel/ distilled water

Interventions

Irrigant type OTHER

The success of endodontic treatment is directly related to infection control. In successful endodontic treatment, it is necessary to perform an ideal irrigation both in order to gain a better understanding of the complex anatomical structure of the root canals and to increase the efficiency of the instruments and methods used during the canal preparation. Sodium hypochlorite (NaOCl) solution is the standard irrigation agent for cleaning and disinfection of root canal. In this study, the effect of NaOCI on postoperative pain using different uniforms will be evaluated.

5.25% NaOCl solution

5.25% NaOCl DRUG

5.25% NaOCl solution

5.25% NaOCl solution

5.25% Cloraxid gel/ distilled water DRUG

5.25% Cloraxid gel/ distilled water

5.25% Cloraxid gel/ distilled water

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy persons between the ages of 18 and 45 years
• Mandibular molar teeth that were diagnosed with symptomatic irreversible pulpitis

You may not qualify if:

• Patients who are taken analgesic inflammatory drugs with in the last 12 hours
• Pregnancy or lactation
• Teeth with calcified canals
• Teeth with periodontal diseases
• Teeth with sensitive to percussion and palpation
• Teeth with root resorption
• Teeth with immature/open apex

Sponsors & Collaborators

• Yuzuncu Yil University: lead

Study Sites (1)

Yuzuncu Yıl University

Van, 65000, Turkey (Türkiye)

Location

Related Publications (1)

• Topcuoglu HS, Topcuoglu G, Arslan H. The Effect of Different Irrigation Agitation Techniques on Postoperative Pain in Mandibular Molar Teeth with Symptomatic Irreversible Pulpitis: A Randomized Clinical Trial. J Endod. 2018 Oct;44(10):1451-1456. doi: 10.1016/j.joen.2018.06.008. Epub 2018 Aug 23.

  PMID: 30144989 RESULT

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Esin Özlek, PhD

  Yuzuncu Yil University

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Endodontics, Principal Investigator, Assistant Professor

Model Details: Group 1: 2 ml of 5.25% NaOCl solution will be used as irrigation solution at every file change during root canal preperation .2 ml dental injector and 27 gauge thickness dental needle tip will be used for irrigation . The tip of the cannula will be adjusted to reach two-thirds of the working length. Group 1: 2 ml of 5.25% Cloraxid gel/ distilled water will be used as irrigation solution at every file change during root canal preperation .2 ml dental injector and 27 gauge thickness dental needle tip will be used for irrigation. The tip of the cannula will be adjusted to reach two-thirds of the working length.

Study Record Dates

• First Submitted: November 25, 2019
• First Posted: December 9, 2019
• Study Start: September 29, 2019
• Primary Completion: December 30, 2019
• Study Completion: December 30, 2019
• Last Updated: December 9, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)