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ACTIVE NOT RECRUITING
NCT07171762
NA

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

Sponsor: KEZBAN MELTEM ÇOLAK

View on ClinicalTrials.gov

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.

Official title: A Randomized Controlled Trial Comparing Intracanal Ozone Therapy and Conventional Irrigation on Oxidative Stress in Asymptomatic Apical Periodontitis

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2024-09-27

Completion Date

2025-10-30

Last Updated

2025-09-18

Healthy Volunteers

No

Interventions

DEVICE

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.

OTHER

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)

Locations (1)

ATATURK UNIVERSITY, FACULTY of DENTISTRY, Department of ENDODONTICS

Erzurum, Erzurum, Turkey (Türkiye)