Clinical and Microbiological Evaluation of 0.5% Versus 3% Sodium Hypochlorite in Root Canal Treatment

August 3, 2018 updated by: Thomas Kvist, Göteborg University

Aim: To compare the clinical antimicrobial and adverse effects of irrigation with Sodium Hypochlorite (NaOCl) 0.5% versus NaOCl 3% during root canal treatment.

Methodology: Consecutive patients referred to a specialist clinic of endodontics are randomly assigned to have the root canal treatment performed with a concomitant irrigation either with a buffered 0.5 % NaOCl (Dakin's solution) or 3 % NaOCl. Teeth with vital or necrotic pulps and retreatment cases were included. Root canal treatment procedures varied but followed the routines of the Specialist Clinic of Endodontics, Public Dental Health, Gothenburg, Sweden. Immediately before the root canal filling a microbial sample is taken from the operative field and the root canal. The bacterial samples were processed at the laboratory as outlined by Möller (1966). After each visit each patient was instructed to fill in a questionnaire and assess his or her post-operative pain on a visual analogue scale (VAS), with endpoints 0= "no pain" and 10= "worst imaginable pain", for seven consecutive days. The Fischer's exact test was used for statistical analyses of the differences in outcome between the groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The aim of the present study is to compare the antimicrobial and immediate clinical effect of NaOCl 0.5% with the effect of NaOCl 3% in the endodontic treatment of teeth referred to the Specialist Clinic of Endodontics, Göteborg, Public dental Health, Västra Götaland. The efficiency of the treatment will be evaluated with sampling and cultivation methods and the assessment of patients' symptoms with a visual analogue scale.

The sample size calculation was performed with a type I error of 0.05 and statistical power of 80 %. The investigators expected 70 % of the samples to be free from bacteria growth in the control group and the investigators considered clinically relevant a difference of 15 % between the groups in order to demonstrate significant differences attributable to the experimental therapy used. The investigators want our sample size to be two hundred sixty four patients, 132 to each group.

A detailed explanation of the purpose of the study was given. Patients were also informed about the confidentiality of the data to be collected and about the voluntary participation. Every patient gets assigned a code that indicates which group they belong so the same irrigant is used in case of more than one visit.

Root canal treatment followed the standard principles of the Specialist Clinic of Endodontics, Göteborg, Public dental Health, Västra Götaland but the treatments were not restricted to a single protocol.

The recommended minimum or optimal apical size of canal preparation is size 25. All the operators are informed to perform the endodontic treatment the way operators normally do. The only variation during treatment was the concentration of the sodium hypochlorite solution for irrigation of the root canal. One group was irrigated with Sodium Hypochlorite 0.5 % (Dakin's solution) and the other group with Sodium Hypochlorite 3 %.

Operators were free to choose any additional irrigant as clinically perceived necessary. The irrigants available at the clinic were 17% ethylene-diamine-tetra-acetic acid (EDTA) and iodine-potassium-iodide (IPI) 5% used as a short duration antimicrobial agent as intracanal medication for 10 minutes.

Canal irrigation was carried out using 27 gauge side-cut open end needles (Monoject Luer lock syringe) with supplementation by ultrasonic agitation. Calcium hydroxide was the standard inter-appointment medicament. After sampling procedures gutta-percha and AH-plus sealer were used for root filling.

The access cavity was filled with Intermediate Restorative Material (IRM) or a permanent filling with composite after each appointment and after finished root canal treatment.

After bacterial sampling of the root canal, the samples were processed at the laboratory as outlined by Möller. Anaerobic incubation was done in a semi liquid medium (Hunton medium) inoculated under flow of oxygen-free gas. The mediums are checked daily for 14 days or until there is signs of microbial growth.

Fischer's exact test will be used for comparisons between groups regarding growth / no growth. For assessments of pain on the VAS t-test and 95% confidence intervals will be used. All hypothesis tests will be conducted at the 0.05 level of significance.

The outcomes will be analysed in term of positive Cultures and post operative pain. This is discussed further elsewhere in this application.

Study Type

Interventional

Enrollment (Actual)

264

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Gothenburg, Sweden
        • Göteborg University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients in need of and willing to have a root canal treatment
  • Diagnosis Pulpitis
  • Diagnosis Apical periodontitis.
  • If a patient was referred for more than one tooth just the first treated tooth was included in the study.
  • The teeth had to be restorable and placement of rubber dam must be possible.

Exclusion Criteria:

  • patient does not understand Swedish
  • the tooth will be treated with a retrograde approach

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Irrigation with 3% NaOCl
After informed consent the patient was randomly assigned to have the root canal treatment performed with a 3 % NaOCl irrigation during instrumentation. If the patient's first visit was on an uneven date the concentration of the irrigant was 3 %.
Procedure: Irrigation with 3% NaOCl
All the operators are informed to perform the endodontic treatment the way they normally do. The only variation during treatment was the concentration of the sodium hypochlorite solution for irrigation of the root canal.
Active Comparator: Irrigation with 0.5% NaOCl
After informed consent the patient was randomly assigned to have the root canal treatment performed with a 0.5 % NaOCl irrigation during instrumentation. If the patient's first visit was on an even date the concentration of the irrigant was 0.5 %.
Procedure: Irrigation with 0.5% NaOCl
All the operators are informed to perform the endodontic treatment the way they normally do. The only variation during treatment was the concentration of the sodium hypochlorite solution for irrigation of the root canal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessing bacterial growth in the root canal (positive meaning cultivable bacteria present, negative meaning absence of cultivable bacteria)
Time Frame: Sample from the root canal taken immediately before root canal filling, assessing growth for 30 days after the sample is taken.
Bacterial sampling was taken just before the root canal filling. The sodium hypochlorite solution and the iodine-potassium-iodide were inactivated with 5 % sodium thiosulfate solution for 30 sec. The canals were then filled with VMGA I, dentinal shavings were produced with H files ISO #25. The entire canal content was absorbed by means of charcoal points and transferred to VMGA III.
Sample from the root canal taken immediately before root canal filling, assessing growth for 30 days after the sample is taken.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of post-operative pain using a questionnaire containing 7 visual scales.
Time Frame: 7 consecutive days after each appointment
Each patient was instructed to fill in a questionnaire after each visit. This questionnaire contains seven visual scales (VAS) based on a 10 cm line determining the pain level. The patient is asked to estimate the pain they have 7 days after the endodontic procedure where 1 is very mild pain and 10 the worse pain they can imagine. The questionnaires were measured with a plastic ruler and the recordings will be transposed to numbers and registered in the excel file by the main investigator.
7 consecutive days after each appointment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Göteborg University

Investigators

  • Study Chair: Thomas Kvist, phD, Göteborg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

August 1, 2018

Study Completion (Actual)

August 1, 2018

Study Registration Dates

First Submitted

January 26, 2016

First Submitted That Met QC Criteria

February 9, 2016

First Posted (Estimate)

February 12, 2016

Study Record Updates

Last Update Posted (Actual)

August 6, 2018

Last Update Submitted That Met QC Criteria

August 3, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Irrigation 3% NaOCl

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

IPD Plan Description

The data is going to be published at a Group level

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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