Adjunctive Ozone Therapy for Residual Periodontal Pockets (OZPOCKET)
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
地位
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
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Erzurum、土耳其(türkiye)
- Ataturk University Faculty of Dentistry, Department of Periodontology
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参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
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
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 |
|---|---|
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有源比较器:Repeated Scaling and Root Planing
Residual periodontal pockets received repeated scaling and root planing alone following periodontal maintenance therapy.
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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:
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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.
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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:
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:
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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 |
|---|---|---|
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Change in Probing Depth
大体时间:Baseline, 3 months, and 6 months after treatment
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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.
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Baseline, 3 months, and 6 months after treatment
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change in Clinical Attachment Level
大体时间:Baseline, 3 months, and 6 months after treatment
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Assessment of changes in clinical attachment level (CAL) after periodontal treatment.
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Baseline, 3 months, and 6 months after treatment
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Bleeding on Probing
大体时间:Baseline, 3 months, and 6 months after treatment
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Assessment of bleeding on probing (BOP) in residual periodontal pockets following treatment.
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Baseline, 3 months, and 6 months after treatment
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BANA Test Results
大体时间:Baseline, 3 months, and 6 months after treatment
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Microbiological evaluation of red complex periodontal pathogens using the benzoyl-DL-arginine naphthylamide (BANA) assay.
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Baseline, 3 months, and 6 months after treatment
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合作者和调查者
出版物和有用的链接
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- ATAUNI-OZONEPOCKET-26
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
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