The Effectiveness of Hyperpure Chlorine Dioxide and Sodium Hypochlorite Irrigants in Endodontic Retreament in RCT

October 26, 2022 updated by: Eniko Vaszine Szabo

The Effectiveness of Hyperpure Chlorine Dioxide and Sodium Hypochlorite Irrigants During Endodontic Retreament on the Healing of Chronic Periapical Lesions - Clinical, Radiological and Microbiological Study. Randomized Clinical Trial.

Endodontic treatment aims to eliminate pathogenic microbes from the root canal. Hyperpure chlorine dioxide is an endodontic irrigant. Our goal is to compare the efficacy of hyperpure chlorine dioxide with the gold standard sodium hypochlorite in the non-surgical retreatment of root canal treated teeth with chronic periapical lesions in a randomized clinical trial. Forty patients having chronic apical periodontitis will randomly be chosen for the study from the patients attending our Department of Conservative Dentistry. Endodontic treatment will be done according to professional quidelines. The patients will randomly be divided into two groups. In the first (control) group sodium hypochlorite, in the second group hyperpure chlorine dioxide will be used as desinfectant. The first sample will be taken from the root canal after removing the previous root canal obturation prior to desinfection. The second sample will be taken one week after temporization. The samples will be evaluated by culturing, MALDI-ToF and PCR strip test. After root canal obturation the the periapical status will be followed by clinical evaluation and control x-rays.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Endodontic treatment aims to eliminate pathogenic microbes from the root canal. This is an almost impossible task as microbes, especially Enterococci are able to line the dentin tubules that are nearly unaccessable to desifectants used during treatment. Hyperpure chlorine dioxide is an endodontic irrigant. In vitro studies proved it to be a very potent desinfectant against which bacteria do not produce resistency. It selectively binds to three amino acids targeting bacterial cells. Due to its small molecular weight and its highly volatile characteristics we presume that it is able to penetrate into the small dentin tubuli. There have been many in vitro studies comparing its characteristics and efficacy, but there have been no in vivo studies done to approve its clinical preformance so far. Our goal is to compare the efficacy of hyperpure chlorine dioxide with the gold standard sodium hypochlorite in the non-surgical retreatment of root canal treated teeth with chronic periapical lesions in a randomized clinical trial. Its efficacy will be compared by microbiological methods and by clinical and radiological evaluation. According to our hypothesis hyperpure chlorine dioxide is more effective antimicrobial agent than the gold standard sodium hypochlorite. The protocol for this clinical study was approved by the Hungarian National Ethics Committee for clinical trials. Forty patients having chronic apical periodontitis will randomly be chosen for the study from the patients attending our Department of Conservative Dentistry. Written consent will be collected from the patients. Only those patients will be accepted who had the root canal treatment done more than four years ago, the tooth is asymptomatic, functionally and esthetically restorable, the coronal restoration can be done within 3-4 weeks of the root canal obturation, who will not have prosthetic or orthodontic treatment interfering with the radiological follow-up and have no general medical conditions or medication influencing the healing of the periapical lesion. Endodontic treatment will be done according to professional quidelines. After sterilizing the tooth and its environment, a sterility test will be be done by taking samples from the top of the restoration (S1) and from the pulp chamber (S2). The root canal obturation will be removed mechanically and a microbiological sample will be taken from the root canal (M1). After taking the sample from the root canal the tooth will be chemomechanically prepared. The patients will randomly be divided into two groups. In the first (control) group sodium hypochlorite, in the second group hyperpure chlorine dioxide will be used as desinfectant. The sample taking procedure will be repeated after one week of temporization (sterility tests S3, S4 and root canal sample M2). The samples will be cultured and identified by MALDI-ToF MS. The remaining samples will be used for PCR testing (Micro-IDent Plus11, Hain Lifescience) to determine the presence of the tested bacteria. In the second session the root canal obturation will be completed. Following coronal restoration a control x-ray will be done by using an individual bite-block for standardization. The success of the root canal treatment will be followed-up by evaluating the periapical status with the Periapical Index scoring system and clinical evaluation according to the criteria set by the European Society of Endodontology including pain assessment where the patients rate pain on the VNRS, with 0 = ''no pain'' to 10 = ''worst pain imaginable". Clinical evaluation and control x-rays will be done at 6 months, 1, 2, 3, and 4 years following treatment. The x-rays will be evaluated by two blinded calibrated examiners.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

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

  • Hungary
      • Budapest, Hungary, 1088
        • Semmelweis University, Dental Faculty, Conservative Dentistry Department

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients attending the clinic

Description

Inclusion Criteria:

• patients having asymptomatic chronic apical periodontitis of size 4-5 according to periapical index scoring system

Exclusion Criteria:

  • patients who suffer from diabetes, osteoporosis, cancer, autoimmue disease
  • patients who are in immune suppressed state
  • patients receiving steroid, bisphosphonate, denosumab or antiangiogenic therapy
  • alcoholism
  • smoking
  • patients having had antibiotic therapy in the past 4 weeks before starting treatment
  • teeth with furcation involvement
  • teeth with deeper than 4 mm probing depth or the same on neighboring teeth
  • patients intending to undergo prosthodontic or orthodontic treatment within four years

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
sodium hypochlorite
group 1: control group with sodium hypochlorite desinfection
Other: endodontic desinfection
  • outcome assessment of the retreatment of endodontically treated teeth presenting chronic apical periodontitis
  • effectiveness of hyperpure chlorine dioxide compared with sodium hypochloride
  • using microbiological methods
  • outcome assessed by radiological method and clinical evaluation
Other Names:
  • hyperpure chlorine dioxide, sodium hypochlorite
hyperpure chlorine dioxide
group 2: study group with hyperpure chlorine dioxide desinfection
Other: endodontic desinfection
  • outcome assessment of the retreatment of endodontically treated teeth presenting chronic apical periodontitis
  • effectiveness of hyperpure chlorine dioxide compared with sodium hypochloride
  • using microbiological methods
  • outcome assessed by radiological method and clinical evaluation
Other Names:
  • hyperpure chlorine dioxide, sodium hypochlorite

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Microbiological assessment
Time Frame: 4 years
The presence of bacteria will be assessed in microbiological samples will be taken from the root canal prior to root canal desinfection after removing obturation and one week after desinfection before obturation. They will be quantified by culturing and specified by MALDI ToF MS. The same samples will be used for PCR strip test to spcify certain test bacteria.
4 years
Radiological assessment
Time Frame: 4 years
After coronal restoration is completed a control x-ray will be taken by means of an individual bite-block. The periapical status will be assessed at the time of obturation-restoration, 6 months, 1, 2, 3, 4 years following endodontic treatment. The outcome will be determined according to the Periapical Index scoring system. The teeth will be evaluated according to healed, healing or unsuccessful as outcome.
4 years
Clinical evaluation
Time Frame: 4 years
At each control appointments a clinical evaluation will be done according to the criteria set by the European Society of Endodontology including: presence of fistula and/or swelling, functionality.
4 years
Clinical evaluation
Time Frame: 4 years
pain evaluated by visual analogue scale
4 years

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Eniko Vaszine Szabo

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Enikő Vasziné Szabó, DMD PhD, Semmelweis University
  • Study Director: Zsolt Lohinai, DMD PhD, Semmelweis University

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 15, 2019

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2023

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 8, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 31, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 26, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • OGYÉI/39205/2018

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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