A Randomized Controlled Trial Comparing Intracanal Ozone Therapy and Conventional Irrigation on Oxidative Stress in Asymptomatic Apical Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in oxidative stress biomarkers in periapical fluid following ozone or saline irrigation
研究概览
简要总结
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.
详细描述
This randomized controlled clinical trial investigates the effect of ozone irrigation on oxidative stress levels in teeth diagnosed with asymptomatic apical periodontitis. Apical periodontitis, characterized by inflammation of periapical tissues in response to persistent root canal infection, often progresses silently and can affect long-term endodontic success. In recent years, ozone therapy has gained attention due to its strong antimicrobial, anti-inflammatory, and tissue-regenerative properties. This study evaluates whether ozone irrigation during endodontic treatment can modulate oxidative stress biomarkers more effectively than traditional saline irrigation.
Study Objective
The primary aim is to compare oxidative stress marker levels (TAS, TOS, MDA, and 8-OHdG) in periapical fluid samples following ozone versus saline irrigation
. Study Design and Participants
A total of 60 patients aged between 18-65, each diagnosed with a single-rooted tooth exhibiting asymptomatic apical periodontitis, were included based on strict inclusion/exclusion criteria. Patients with systemic disease, recent antibiotic use, or periodontal involvement were excluded. Randomization was conducted via [www.randomizer.org\](http://www.randomizer.org) to allocate participants into two groups (n=30 each):
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (Participant)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Patients must be between 18 and 65 years of age
- •Single-rooted, asymptomatic apical periodontitis with necrotic teeth
- •Teeth with periapical lesion size classified as score 3 or 4 according to the Orstavik classification
- •Periapical Assessment Index (PAI) of 2 or higher
- •Patients with ASA I status
排除标准
- •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
研究组 & 干预措施
Ozone Irrigation Group
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.
干预措施: Ozonytron XP (Device)
Saline Irrigation Group (Control)
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
干预措施: Physiological saline solution (0.9% NaCl) (Other)
结局指标
主要结局
Change in oxidative stress biomarkers in periapical fluid following ozone or saline irrigation
时间窗: 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.
次要结局
未报告次要终点
研究者
KEZBAN MELTEM ÇOLAK
Professor of Endodontics,
Ataturk University