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

NCT04954638 | Unknown

• 1 other identifier: OGYÉI/39205/2018
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Persistent Infection; Periapical Lesion

Keywords

hyperpure chlorine dioxide; sodium hypochlorite

Outcome Measures

Primary Outcomes (4)

• 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

• 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

• 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

• Clinical evaluation

  pain evaluated by visual analogue scale

  4 years

Study Arms (2)

sodium hypochlorite

group 1: control group with sodium hypochlorite desinfection

Other: endodontic desinfection

hyperpure chlorine dioxide

group 2: study group with hyperpure chlorine dioxide desinfection

Other: endodontic desinfection

Interventions

endodontic desinfection OTHER

* 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

Also known as: hyperpure chlorine dioxide, sodium hypochlorite

hyperpure chlorine dioxide; sodium hypochlorite

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

patients attending the clinic

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eniko Vaszine Szabo: lead

Study Sites (1)

Semmelweis University, Dental Faculty, Conservative Dentistry Department

Budapest, 1088, Hungary

Location

Biospecimen

Retention: SAMPLES WITH DNA

Biospecimen Description microbiological samples taken during the mechanical removal of the root canal obturation using paper points and endodontic files without human DNA

MeSH Terms

Conditions

Persistent Infection

Interventions

Sodium Hypochlorite

Condition Hierarchy (Ancestors)

Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Hypochlorous Acid; Chlorine Compounds; Inorganic Chemicals; Oxides; Oxygen Compounds; Sodium Compounds

Study Officials

• Enikő Vasziné Szabó, DMD PhD

  Semmelweis University

  PRINCIPAL INVESTIGATOR

• Zsolt Lohinai, DMD PhD

  Semmelweis University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: principal investigator

Study Record Dates

• First Submitted: June 29, 2021
• First Posted: July 8, 2021
• Study Start: November 15, 2019
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2025
• Last Updated: October 31, 2022

Record last verified: 2022-10

Locations

HU (1)