- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04954638
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
Enrolling by invitation
Conditions
Intervention / Treatment
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
Observational
Enrollment (Anticipated)
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
-
-
-
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
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 |
Intervention / Treatment |
---|---|
sodium hypochlorite
group 1: control group with sodium hypochlorite desinfection
|
Other Names:
|
hyperpure chlorine dioxide
group 2: study group with hyperpure chlorine dioxide desinfection
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
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
Investigators
- 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)
November 15, 2019
Primary Completion (Anticipated)
July 31, 2023
Study Completion (Anticipated)
July 31, 2025
Study Registration Dates
First Submitted
June 29, 2021
First Submitted That Met QC Criteria
June 29, 2021
First Posted (Actual)
July 8, 2021
Study Record Updates
Last Update Posted (Actual)
October 31, 2022
Last Update Submitted That Met QC Criteria
October 26, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Persistent Infection
-
ANRS, Emerging Infectious DiseasesUniversity College London Hospitals; Hospital Clinic of Barcelona; Imperial College... and other collaboratorsCompletedHIV-1-infectionFrance, United Kingdom, Switzerland
-
Tanta UniversityNot yet recruitingPersistent Helicobacter Pylori InfectionEgypt
-
Region SkaneRecruitingLatent Tuberculosis | Mycobacterium Tuberculosis | Persistent InfectionSweden
-
Foundation IRCCS San Matteo HospitalActive, not recruitingHPV-Related Cervical CarcinomaItaly
-
University of FloridaNot yet recruitingAmputations for Management of Sarcoma,Trauma,or Chronic Infection
-
Centre Hospitalier Régional d'OrléansRecruitingHIV Infections | Autophagy | Galectins | Highly Active Antiretroviral TherapyFrance
-
Universidad Autonoma de Nuevo LeonHospital Universitario Dr. Jose E. GonzalezRecruitingPersistent Epithelial DefectMexico
-
Aarhus University HospitalCompleted
-
Merck Sharp & Dohme LLCActive, not recruitingPapillomavirus InfectionsUnited States, Belgium, Brazil, Colombia, Czechia, France, Germany, Israel, Italy, Japan, Korea, Republic of, Mexico, Peru, Spain, Taiwan, Thailand
-
Memorial Sloan Kettering Cancer CenterRecruitingCMV Infection | Persistent CMV ViremiaUnited States
Clinical Trials on endodontic desinfection
-
University of Sao PauloCompletedTeeth, Endodontically-TreatedBrazil
-
Odontos, Specialisticna Zobna Ambulanta, d.o.o.University of Ljubljana, Faculty of MedicineRecruitingApical Periodontitis | Apical Granuloma | Apical CystSlovenia
-
Ain Shams UniversityCompleted
-
Federal University of PelotasCompletedEndodontically Treated Teeth | Tooth Discoloration | Root Canal InfectionBrazil
-
Fausto Medeiros MendesCompletedEndodontic Treatment of Primary TeethBrazil
-
Mansoura UniversityCompletedNecrotic Pulp | Regenerative Endodontic ProceduresEgypt
-
Postgraduate Institute of Dental Sciences RohtakCompletedApical Periodontitis | Diabete Type 2India
-
Universitaire Ziekenhuizen KU LeuvenRecruitingApical Periodontitis | Apical Periodontal CystBelgium
-
Ain Shams UniversityCompleted
-
Universidade do Vale do SapucaiCompletedMandibular Hypoplasia