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

Persistent Infection Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04954638
• Other study ID #: OGYÉI/39205/2018
• Status: Enrolling by invitation
• Start date: November 15, 2019
• Est. completion date: July 31, 2025

Study information

• Verified date: October 2022
• Source: Semmelweis University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 40
• Est. completion date: July 31, 2025
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Periapical Lesion
• Persistent Infection

Intervention

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

Locations

Country	Name	City	State
Hungary	Semmelweis University, Dental Faculty, Conservative Dentistry Department	Budapest

Sponsors (1)

Lead Sponsor	Collaborator
Eniko Vaszine Szabo

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microbiological assessment	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
Primary	Radiological assessment	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
Primary	Clinical evaluation	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
Primary	Clinical evaluation	pain evaluated by visual analogue scale	4 years