The Effect of Hypochlorous Acid in the Non-Surgical Treatment of Stage I and Stage II Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Plaque Index (PI)
研究概览
简要总结
Periodontitis is a chronic inflammatory disease associated with dental plaque and characterized by the progressive destruction of the tooth-supporting tissues. The principal features of periodontitis include clinical attachment loss (CAL), alveolar bone loss, periodontal pocket formation, gingival bleeding, and the subsequent loss of periodontal tissue support.
The current gold standard for the management of periodontal disease comprises oral hygiene instruction (OHI), non-surgical periodontal therapy (NSPT), periodontal surgery when indicated, and supportive periodontal therapy (SPT). In addition, various antimicrobial agents are used as adjuncts to periodontal treatment. One such agent, hypochlorous acid (HOCl), is a potent antimicrobial with high affinity against Gram-negative bacteria within the subgingival biofilm. Hypochlorous acid is commercially available in mouthwash and spray formulations, which patients may use as adjunctive therapies following periodontal treatment.
In the present project, hypochlorous acid will be applied by the clinician using a dental device during periodontal treatment in a clinical setting. Changes in both clinical and biochemical outcomes, including high-sensitivity C-reactive protein (hs-CRP), C-reactive protein (CRP), antistreptolysin O (ASO), and oncostatin M (OSM), will be recorded and compared with those obtained following conventional periodontal treatment performed using purified water.
The novelty of the proposed study lies in the first-time use of hypochlorous acid as an irrigant in place of purified water during scaling and root planing (SRP), with the aim of evaluating its effects on both clinical and biochemical parameters. This project is expected to attract the attention of researchers investigating the treatment of periodontitis and may facilitate publication in high-impact international peer-reviewed journals as well as presentation at prestigious scientific congresses. Furthermore, it will contribute to the training of qualified researchers in periodontology and support the completion of a doctoral dissertation. The findings may also provide preliminary data for future studies aimed at developing hypochlorous acid-based adjunctive therapeutic approaches for the management of periodontitis.
详细描述
Periodontitis is a chronic inflammatory disease that may ultimately lead to tooth loss as a consequence of bacterial-induced destruction of the periodontal tissues. It is characterized by an inflammatory response to dental plaque within the periodontal connective tissue and alveolar bone, and the nature and magnitude of this host response largely determine disease progression. Scaling and root planing (SRP) is considered the gold standard for the treatment of periodontitis. The cornerstone of non-surgical periodontal therapy is the mechanical removal of microbial biofilm and calculus through SRP. However, SRP alone may not be sufficient to eliminate pathogenic bacteria, as these microorganisms can persist within the gingival tissues and in anatomical areas that are difficult to access using conventional periodontal instrumentation, including deep periodontal pockets, furcation involvements, interproximal areas, and root concavities. Therefore, local or systemic antimicrobial agents and antiseptics have been recommended as adjunctive therapies to improve periodontal treatment outcomes.
Owing to its antimicrobial, anti-inflammatory, and wound-healing properties, hypochlorous acid is currently used in various dental applications, including biofilm eradication, mouth rinses, wound care, endodontic irrigation, root surface conditioning, and the treatment of peri-implantitis.
This study has been designed as a single-center, randomized, controlled, prospective clinical trial to be conducted at the Department of Periodontology, Faculty of Dentistry, Atatürk University. A total of 44 systemically healthy individuals aged 18-65 years diagnosed with Stage I or Stage II periodontitis will be enrolled in the study.
Participants will be randomly allocated into two groups using a coin-toss randomization method:
Test group: Scaling and root planing (SRP) performed using hypochlorous acid. Control group: Scaling and root planing (SRP) performed using purified water.
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
- Single (Outcomes Assessor)
盲法说明
The clinical outcome assessor will be blinded to group allocation. The clinician performing the intervention will be aware of the assigned treatment; however, participants will not be explicitly informed of their group allocation.
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
- •Individuals aged 18 to 65 years.
- •Systemically healthy individuals.
- •Diagnosis of Stage I or Stage II periodontitis according to the 2017 Classification of Periodontal Diseases.
- •Probing pocket depth (PPD) ≤5 mm and clinical attachment loss (CAL) ≤4 mm.
- •Presence of a sufficient number of teeth for periodontal evaluation.
- •Willingness to participate and ability to provide written informed consent.
排除标准
- •Patients with contraindications to the use of ultrasonic instrumentation.
- •Pregnant or lactating women.
- •Patients receiving anti-inflammatory or antibiotic therapy.
- •Patients with systemic diseases or medical conditions.
- •Patients receiving continuous medication for any medical condition.
- •Patients who have undergone periodontal treatment within the previous 6 months.
- •Patients presenting with acute dental pain (e.g., pulpitis or apical/periodontal abscess).
- •Individuals who smoke or consume alcohol.
- •Presence of fewer than 15 teeth.
结局指标
主要结局
Plaque Index (PI)
时间窗: Baseline, 1 month and 3 months
Assessment of dental plaque accumulation.
Probing Pocket Depth (PPD)
时间窗: Baseline, 1 month and 3 months
Assessment of probing pocket depth (PPD), measured in millimeters, to evaluate clinical periodontal healing.
Clinical Attachment Level (CAL)
时间窗: Baseline, 1 month and 3 months
Assessment of clinical attachment level (CAL), measured in millimeters, as an indicator of periodontal tissue healing.
Bleeding on Probing (BOP)
时间窗: Baseline, 1 month and 3 months
Assessment of gingival bleeding following periodontal probing.
次要结局
- C-Reactive Protein (CRP)(Baseline, 1 month, and 3 months)
- High-Sensitivity C-Reactive Protein (hs-CRP)(Baseline, 1 month and 3 months)
- Oncostatin M (OSM)(Baseline, 1 month and 3 months)
- Antistreptolysin O (ASO)(Baseline, 1 month and 3 months)
研究者
Alparslan Dilsiz
Professor
Ataturk University