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Adjunctive Ozone Therapy for Residual Periodontal Pockets (OZPOCKET)

2026年5月17日 更新者:Alparslan Dilsiz、Ataturk University

Clinical and Microbiological Effects of Adjunctive Ozone Application During Repeated Scaling and Root Planing for Residual Periodontal Pockets in Periodontal Maintenance Patients: A 6-Month Randomized Controlled Clinical Trial

Patients with residual periodontal pockets following non-surgical periodontal therapy remain at risk for disease progression and may require further periodontal surgery. Repeated scaling and root planing (SRP) is commonly used for residual pockets; however, complete elimination of periodontal pathogens is often difficult to achieve. Ozone therapy has antimicrobial, anti-inflammatory, and wound-healing properties that may improve periodontal treatment outcomes.

The aim of this randomized controlled clinical trial is to clinically and microbiologically evaluate the adjunctive effects of gaseous ozone application during repeated SRP for residual periodontal pockets in patients undergoing periodontal maintenance therapy. Twenty-six patients diagnosed with stage III or IV periodontitis presenting with residual periodontal pockets ≥5 mm with bleeding on probing will be included. Residual pockets will be randomly assigned to either repeated SRP alone (control group) or repeated SRP combined with ozone application (test group).

Clinical periodontal parameters and microbiological findings will be evaluated at baseline, 3 months, and 6 months after treatment.

研究概览

详细说明

Periodontitis is a chronic multifactorial inflammatory disease associated with dysbiotic subgingival biofilm and progressive destruction of tooth-supporting tissues. Although scaling and root planing (SRP) represents the gold standard of non-surgical periodontal therapy, residual periodontal pockets may persist after treatment, especially in patients with stage III and IV periodontitis. Residual pockets ≥5 mm with bleeding on probing are associated with increased risk of disease recurrence and often require additional interventions.

Adjunctive therapeutic approaches have been proposed to improve outcomes of non-surgical periodontal treatment. Ozone therapy has attracted increasing interest in periodontology because of its antimicrobial, anti-inflammatory, antihypoxic, immunomodulatory, and wound-healing effects. However, evidence regarding the adjunctive use of ozone in residual periodontal pockets remains limited.

This study was designed as a split-mouth, randomized-controlled, double-blind clinical trial with a 6-month follow-up period. Twenty-six systemically healthy individuals diagnosed with stage III or IV periodontitis and undergoing periodontal maintenance therapy will be included. Patients presenting with residual periodontal pockets ≥5 mm with bleeding on probing following previous non-surgical periodontal treatment will be enrolled.

Residual periodontal pockets will be randomly assigned to one of the following groups:

Control group: repeated scaling and root planing alone Test group: repeated scaling and root planing combined with gaseous ozone application

Clinical periodontal measurements including plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing depth (PD), recession depth (RD), and clinical attachment level (CAL) will be recorded using a standardized acrylic stent and a UNC-15 periodontal probe. Microbiological evaluation will be performed using the benzoyl-DL-arginine naphthylamide (BANA) enzymatic assay.

Ozone application will be performed using the OzoneDTA device with a periodontal probe tip according to the manufacturer's instructions. Clinical and microbiological evaluations will be performed at baseline, 3 months, and 6 months.

The primary objective of this study is to evaluate whether adjunctive ozone application improves clinical periodontal outcomes in residual periodontal pockets compared with repeated SRP alone.

研究类型

介入性

注册 (实际的)

26

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Erzurum、土耳其(türkiye)
        • Ataturk University Faculty of Dentistry, Department of Periodontology

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

不

描述

Inclusion Criteria:

  • Systemically healthy individuals
  • Patients diagnosed with stage III or IV periodontitis
  • Patients undergoing periodontal maintenance therapy
  • Presence of at least two residual periodontal pockets ≥5 mm with bleeding on probing
  • Presence of radiographic bone loss ≥3 mm
  • Plaque Index (PI) <1 before treatment
  • Ability and willingness to attend all follow-up visits
  • Written informed consent obtained

Exclusion Criteria:

  • Presence of systemic diseases affecting periodontal healing
  • Pregnancy or lactation
  • Tobacco or alcohol use
  • Use of medications affecting periodontal tissues or wound healing
  • Periodontal treatment within the previous 6 months
  • Presence of carious lesions or periapical pathology on selected teeth
  • Furcation involvement
  • Tooth mobility ≥ degree 1
  • Restorations on selected teeth

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
有源比较器:Repeated Scaling and Root Planing
Residual periodontal pockets received repeated scaling and root planing alone following periodontal maintenance therapy.
Repeated scaling and root planing of residual periodontal pockets was performed using mini-curettes under local anesthesia following periodontal maintenance therapy.
其他名称:
  • Subgingival Reinstrumentation
实验性的:Repeated Scaling and Root Planing Plus Ozone
Residual periodontal pockets received repeated scaling and root planing combined with gaseous ozone application following periodontal maintenance therapy.
Repeated scaling and root planing of residual periodontal pockets was performed using mini-curettes under local anesthesia following periodontal maintenance therapy.
其他名称:
  • Subgingival Reinstrumentation
Gaseous ozone was applied into residual periodontal pockets using the OzoneDTA device with a periodontal probe tip according to the manufacturer's instructions.
其他名称:
  • 臭氧疗法

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Probing Depth
大体时间:Baseline, 3 months, and 6 months after treatment
Assessment of changes in periodontal probing depth (PD) in residual periodontal pockets following repeated scaling and root planing with or without adjunctive gaseous ozone application.
Baseline, 3 months, and 6 months after treatment

次要结果测量

结果测量
措施说明
大体时间
Change in Clinical Attachment Level
大体时间:Baseline, 3 months, and 6 months after treatment
Assessment of changes in clinical attachment level (CAL) after periodontal treatment.
Baseline, 3 months, and 6 months after treatment
Bleeding on Probing
大体时间:Baseline, 3 months, and 6 months after treatment
Assessment of bleeding on probing (BOP) in residual periodontal pockets following treatment.
Baseline, 3 months, and 6 months after treatment
BANA Test Results
大体时间:Baseline, 3 months, and 6 months after treatment
Microbiological evaluation of red complex periodontal pathogens using the benzoyl-DL-arginine naphthylamide (BANA) assay.
Baseline, 3 months, and 6 months after treatment

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2024年3月15日

初级完成 (实际的)

2024年12月15日

研究完成 (实际的)

2025年1月20日

研究注册日期

首次提交

2026年5月17日

首先提交符合 QC 标准的

2026年5月17日

首次发布 (实际的)

2026年5月22日

研究记录更新

最后更新发布 (实际的)

2026年5月22日

上次提交的符合 QC 标准的更新

2026年5月17日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Individual participant data will not be publicly available due to privacy and confidentiality considerations.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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