The Effect of Adjunctive Ozone Therapy on Clinical Outcomes Following Open Flap Debridement in Patients With Stage III Periodontitis: A Randomized Split-Mouth Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Change in Probing Pocket Depth (PPD)
研究概览
简要总结
Periodontitis is a chronic inflammatory disease characterized by the destruction of supporting periodontal tissues. Open flap debridement (OFD) is a commonly used surgical approach for the treatment of deep periodontal pockets when non-surgical therapy is insufficient. However, complete elimination of pathogenic microorganisms remains challenging.
Ozone therapy has been proposed as an adjunctive treatment due to its antimicrobial, anti-inflammatory, and wound healing properties. This randomized split-mouth clinical trial aims to evaluate the clinical effectiveness of adjunctive ozone therapy in patients with Stage III periodontitis undergoing OFD.
A total of 24 systemically healthy patients diagnosed with Stage III periodontitis were included in the study. In each patient, one side was randomly assigned to receive OFD combined with ozone therapy (test group), while the contralateral side received OFD alone (control group).
Clinical periodontal parameters, including plaque index (PI), gingival index (GI), bleeding on probing (BOP), probing pocket depth (PPD), and clinical attachment level (CAL), were recorded at baseline and at 6 and 12 months after treatment.
The study aims to determine whether adjunctive ozone therapy improves clinical outcomes compared to conventional OFD alone.
详细描述
The primary objective of this study is to evaluate the clinical effects of adjunctive ozone therapy on periodontal parameters following open flap debridement (OFD) in patients with Stage III periodontitis.
Periodontitis is a multifactorial disease associated with microbial biofilms that lead to progressive destruction of the supporting structures of the teeth. Mechanical debridement alone may not completely eliminate subgingival pathogens, particularly in deep periodontal pockets and anatomically complex areas. Therefore, surgical intervention such as OFD is often required to provide better access for debridement and improve clinical outcomes.
Ozone therapy has been increasingly investigated in dentistry due to its antimicrobial, anti-inflammatory, and biostimulatory properties. It has been suggested that ozone may enhance wound healing and reduce microbial load when used as an adjunct to conventional periodontal therapy.
This study was designed as a randomized split-mouth clinical trial. Twenty-four patients diagnosed with Stage III periodontitis were included. Each patient contributed two treatment sites, which were randomly allocated into test and control groups. The test group received OFD combined with ozone application, whereas the control group received OFD alone.
All participants underwent initial periodontal therapy, including oral hygiene instructions and scaling and root planing. Standardized clinical measurements were performed using a periodontal probe with the aid of customized acrylic stents to ensure reproducibility.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged between 25 and 65 years
- •Diagnosed with Stage III periodontitis
- •Presence of at least 20 teeth
- •Presence of periodontal pockets ≥5 mm in at least two teeth
- •Indication for open flap debridement
- •Systemically healthy individuals
- •No periodontal treatment within the last 6 months
排除标准
- •Pregnant or breastfeeding women
- •Presence of systemic diseases that may affect periodontal healing
- •Use of antibiotics or anti-inflammatory drugs within the last 6 months
- •Smoking or tobacco use
- •History of periodontal treatment within the last 6 months
- •Patients with poor oral hygiene compliance
研究组 & 干预措施
Ozone Group
Sites treated with open flap debridement combined with adjunctive ozone therapy.
干预措施: Open Flap Debridement (Procedure)
Ozone Group
Sites treated with open flap debridement combined with adjunctive ozone therapy.
干预措施: Ozone Therapy (Device)
Control Group
Sites treated with open flap debridement alone without adjunctive ozone therapy.
干预措施: Open Flap Debridement (Procedure)
结局指标
主要结局
Change in Probing Pocket Depth (PPD)
时间窗: Baseline to 12 months
Probing pocket depth (PPD) will be measured in millimeters using a periodontal probe at baseline and 12 months after treatment. The outcome represents the change in PPD between baseline and follow-up.
次要结局
- Change in Clinical Attachment Level (CAL)(Baseline to 12 months)
- Change in Bleeding on Probing (BOP)(Baseline to 12 months)
- Change in Gingival Index (GI)(Baseline to 12 months)
- Change in Plaque Index (PI)(Baseline to 12 months)
研究者
Alparslan Dilsiz
Professor
Ataturk University