The Effect of Irrigant Types Used During Endodontic Treatment on Postoperative Pain
Primary Purpose
Postoperative Pain
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Irrigant type
5.25% NaOCl
5.25% Cloraxid gel/ distilled water
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Pain focused on measuring Root canal, irrigation, irrigant type, postoperative pain
Eligibility Criteria
Inclusion Criteria:
- Healthy persons between the ages of 18 and 45 years
- Mandibular molar teeth that were diagnosed with symptomatic irreversible pulpitis
Exclusion Criteria:
- 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
Sites / Locations
- Yuzuncu Yıl University
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
5.25% NaOCl solution
5.25% Cloraxid gel/ distilled water
Arm Description
5.25% NaOCl solution will be used as irrigation solution at every file change during root canal preperation
5.25% Cloraxid gel/ distilled water will be used as irrigation solution at every file change during root canal preperation
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04190355
First Posted
November 25, 2019
Last Updated
December 6, 2019
Sponsor
Yuzuncu Yıl University
1. Study Identification
Unique Protocol Identification Number
NCT04190355
Brief Title
The Effect of Irrigant Types Used During Endodontic Treatment on Postoperative Pain
Official Title
The Effect of Irrigant Types Used During Endodontic Treatment on Postoperative Pain: a Randomized Controlled Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Unknown status
Study Start Date
September 29, 2019 (Actual)
Primary Completion Date
December 30, 2019 (Anticipated)
Study Completion Date
December 30, 2019 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yuzuncu Yıl University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The study is planned to be performed on 104 patients who are aged between 18-45 years and who have no systemic disease and are diagnosed and followed up in Yüzüncü Yıl University Faculty of Dentistry, Department of Endodontics.
Patients who have been diagnosed with irreversible pulpitis will be included in the study group.
Patients with periapical lesions and incomplete apex development will not be included in the study group.
The access cavity will be prepared under local anesthesia.Working length of the canal will be determined as it ends in apical constriction, by using 15 k file with apex locater and periapical radiographs.
Preperation of root canals will be finished with ProTaperNext X3 instrument as standard and applied to each patient.
All patients will be randomly divided into two groups according to the irrigation protocol (G1: 5.25% NaOCI; G2: Chloraxid gel / distilled water) (n = 250).
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.
Final irrigation procedure after canal preperation, 5 ml of 5.25% NaOCl solution, 5 ml of 17% EDTA solution, 5.25% NaOCl solution will be used respectively for both groups as standard.
After the final irrigation process, the root canals will be dried with sterile paper points, then they will be filled with sterile gutta-percha with lateral condensation technique by hand spredars. After root canal filling teeth will be restorated for coronal sealing.
After the treatment, the patients in both groups will be asked to report the pain levels at certain intervals (6th hour-24th hour-48th hour-72th hour-1st week) according to the VAS scale.
According to the questionnaires collected with patient feedbacks, the data will be analyzed and interpreted with statistical analysis ** (manwithney u-kruskall Wallis) in order to evaluate the pain levels after single visit root canal treatment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Root canal, irrigation, irrigant type, postoperative pain
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
5.25% NaOCl solution
Arm Type
Active Comparator
Arm Description
5.25% NaOCl solution will be used as irrigation solution at every file change during root canal preperation
Arm Title
5.25% Cloraxid gel/ distilled water
Arm Type
Active Comparator
Arm Description
5.25% Cloraxid gel/ distilled water will be used as irrigation solution at every file change during root canal preperation
Intervention Type
Other
Intervention Name(s)
Irrigant type
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
5.25% NaOCl
Intervention Description
5.25% NaOCl solution
Intervention Type
Drug
Intervention Name(s)
5.25% Cloraxid gel/ distilled water
Intervention Description
5.25% Cloraxid gel/ distilled water
Primary Outcome Measure Information:
Title
VAS scala
Description
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.
Time Frame
up to 7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy persons between the ages of 18 and 45 years
Mandibular molar teeth that were diagnosed with symptomatic irreversible pulpitis
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Esin Özlek, PhD
Organizational Affiliation
Yuzuncu Yıl University
Official's Role
Study Chair
Facility Information:
Facility Name
Yuzuncu Yıl University
City
Van
ZIP/Postal Code
65000
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
30144989
Citation
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.
Results Reference
result
Learn more about this trial
The Effect of Irrigant Types Used During Endodontic Treatment on Postoperative Pain
We'll reach out to this number within 24 hrs