Effect of Ozone Use in Intracanal Irrigation on Oxidative Stress Level in Teeth With Asymptomatic Apical Periodontitis

Condition(s) studied

Investigational drug(s) / intervention(s)

Ozonytron XP: This intervention involves the use of ozonated water as a final irrigation solution during root canal treatment in teeth diagnosed with asymptomatic apical periodontitis. Following standard chemomechanical preparation, ozonated water is delivered into the root canal system using a 30-gauge side-vented needle. The aim is to assess the biochemical changes in periapical tissues by evaluating oxidative stress markers (TAS, TOS, MDA, 8-OHdG) in the apical fluid samples collected before and after irrigation. The ozonated water is generated via a medical-grade ozone generator, and its application is designed to minimize cytotoxicity while maximizing antimicrobial and oxidative stress modulation properties. The outcomes are compared to a control group receiving saline irrigation under identical procedural conditions.

Physiological saline solution (0.9% NaCl): Physiological saline solution (0.9% NaCl) was used as the final irrigation agent in root canal treatment.Saline Irrigation Group (Control)

Study summary

This clinical study aims to investigate the oxidative stress-related effects of ozone irrigation in patients with asymptomatic apical periodontitis undergoing root canal treatment. A total of 60 patients who meet the inclusion criteria will be randomly assigned into two groups using an online randomization tool: an ozone irrigation group and a saline irrigation (control) group. The primary objective is to assess the biochemical effects of ozone therapy on oxidative stress markers in periapical interstitial fluid, including but not limited to TAS, TOS, MDA, and 8-OHdG, by using ELISA kits.

After routine canal preparation and initial irrigation protocol (NaOCl-EDTA-NaOCl), baseline periapical fluid samples will be collected using standardized sterile paper points. Following this, experimental irrigation will be applied: ozone water in the study group and saline solution in the control group. Second periapical fluid samples will be collected immediately after this procedure. Subsequently, calcium hydroxide dressing will be placed into the canals, and the patients will be recalled after one week. At the second visit, after removal of the intracanal medicament, a third sample will be collected from each patient.

Ethical approval was obtained from the Non-Interventional Clinical Research Ethics Committee of Atatürk University Faculty of Medicine. The results of this study are expected to contribute to the understanding of ozone therapy as a biocompatible and effective disinfection agent in endodontic procedures and to provide insights into its role in modulating oxidative stress within the periapical environment.

Eligibility

Primary outcome measure(s)

• Change in oxidative stress biomarkers in periapical fluid following ozone or saline irrigation — From baseline to 7 days after treatment
  The primary outcome is the quantitative change in oxidative stress markers including Total Antioxidant Status (TAS), Total Oxidant Status (TOS), Malondialdehyde (MDA), and 8-Hydroxy-2'-deoxyguanosine (8-OHdG) in periapical fluid. Measurements are taken at three time points: Immediately after canal preparation and final irrigation (ozonated water or saline), After application of the irrigant (ozonated water in the test group, saline in the control group), One week later, following the removal of calcium hydroxide medication. Samples are collected using sterile paper points and analyzed using ELISA and Western blot techniques. The purpose is to evaluate the antioxidant and oxidative stress responses to ozonated water compared to saline.

Trial sites (1)

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