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

NCT07171762 | Active Not Recruiting

• 1 other identifier: B.30.2.ATA.0.01.00/557
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Apical Periodontitis; Oxidative Stress

Keywords

Ozone Therapy; Endodontics; Oxidative Stress; Apical Periodontitis; Intracanal Irrigation; Antioxidant Status; Oxidant Status; Malondialdehyde (MDA); 8-Hydroxydeoxyguanosine (8-OHdG)

Outcome Measures

Primary Outcomes (1)

• Change in oxidative stress biomarkers in periapical fluid following ozone or saline irrigation

  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.

  From baseline to 7 days after treatment

Study Arms (2)

Ozone Irrigation Group

EXPERIMENTAL

Participants in this arm will undergo root canal irrigation using ozonated water instead of conventional irrigants. Ozonated water is generated using a medical ozone generator (Ozonytron XP) and applied passively into the canal space. The aim is to evaluate its effect on oxidative stress markers such as TAS, TOS, MDA, and 8-OHdG in periapical fluid collected before and after irrigation. The irrigation protocol includes passive delivery with 30G side-vented needles following initial canal shaping. No sodium hypochlorite or EDTA is used in this group. This arm is designed to assess the biological impact of ozonated water as an alternative disinfection protocol in asymptomatic apical periodontitis.

Device: Ozonytron XP

Saline Irrigation Group (Control)

ACTIVE COMPARATOR

Participants in this group will receive conventional root canal irrigation using sterile saline (0.9% NaCl) solution. This irrigation is delivered passively into the canal space after instrumentation, using 30G side-vented irrigation needles. No active chemical disinfectant such as NaOCl or EDTA is used in this arm. Periapical fluid samples will be collected before and after irrigation, and analyzed for oxidative stress markers (TAS, TOS, MDA, and 8-OHdG). This group serves as a control to compare the biological effects of ozonated water irrigation in asymptomatic apical periodontitis cases

Other: Physiological saline solution (0.9% NaCl)

Interventions

Ozonytron XP DEVICE

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.

Ozone Irrigation Group

Physiological saline solution (0.9% NaCl) OTHER

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

Saline Irrigation Group (Control)

Eligibility Criteria

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

You may qualify if:

• \. Patients must be between 18 and 65 years of age 2. Single-rooted, asymptomatic apical periodontitis with necrotic teeth 3. Teeth with periapical lesion size classified as score 3 or 4 according to the Orstavik classification 4. Periapical Assessment Index (PAI) of 2 or higher 5. Patients with ASA I status

You may not qualify if:

• Teeth with multiple roots
• Patients with ASA II or higher
• Pregnant women or those suspected of being pregnant
• Patients with a history of allergies
• Teeth with excessive material loss where a rubber dam cannot be applied
• Teeth with root fractures or an open apex
• Teeth that have previously undergone root canal treatment
• Presence of canal curvature greater than Schilder 25°,
• Patients with generalized periodontitis,
• Presence of a periodontal pocket greater than 3mm in the relevant tooth

Sponsors & Collaborators

• KEZBAN MELTEM ÇOLAK: lead

Study Sites (1)

ATATURK UNIVERSITY, FACULTY of DENTISTRY, Department of ENDODONTICS

Erzurum, Erzurum, 25240, Turkey (Türkiye)

Location

Related Publications (3)

• Azarpazhooh A, Limeback H. The application of ozone in dentistry: a systematic review of literature. J Dent. 2008 Feb;36(2):104-16. doi: 10.1016/j.jdent.2007.11.008. Epub 2007 Dec 31.

  PMID: 18166260 BACKGROUND

• Kazancioglu HO, Kurklu E, Ezirganli S. Effects of ozone therapy on pain, swelling, and trismus following third molar surgery. Int J Oral Maxillofac Surg. 2014 May;43(5):644-8. doi: 10.1016/j.ijom.2013.11.006. Epub 2013 Dec 11.

  PMID: 24332588 BACKGROUND

• Nagayoshi M, Fukuizumi T, Kitamura C, Yano J, Terashita M, Nishihara T. Efficacy of ozone on survival and permeability of oral microorganisms. Oral Microbiol Immunol. 2004 Aug;19(4):240-6. doi: 10.1111/j.1399-302X.2004.00146.x.

  PMID: 15209994 BACKGROUND

Related Links

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MeSH Terms

Conditions

Periapical Periodontitis

Condition Hierarchy (Ancestors)

Periapical Diseases; Jaw Diseases; Stomatognathic Diseases; Periodontal Diseases; Mouth Diseases; Periodontitis

Study Officials

• Kezban Meltem Çolak, Prof.Dr.

  ATATURK UNIVERSITY, FACULTY of DENTISTRY, Department of ENDODONTICS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This study uses a single-blind design in which the participants are unaware of the intervention type (ozone or saline irrigation) they receive. The operator performing the root canal therapy is aware of the group assignment due to the nature of the intervention procedure. Outcome assessments are performed by the same clinician and are thus not blinded.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor of Endodontics,

Model Details: Participants were randomly assigned to one of two parallel groups. The experimental group received ozone irrigation and the control group received saline irrigation during endodontic treatment. Oxidative stress markers were analyzed at multiple time points.

Study Record Dates

• First Submitted: September 6, 2025
• First Posted: September 15, 2025
• Study Start: September 27, 2024
• Primary Completion: October 20, 2024
• Study Completion: October 30, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)