The Effect of Chlorhexidine and Zinc as Adjuncts to Non-Surgical Periodontal Therapy in Stage I and II Periodontitis: A Randomized Controlled Clinical Trial
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
- Probing Pocket Depth (PPD)
研究概览
简要总结
Periodontitis is a chronic inflammatory disease affecting the supporting structures of the teeth and is associated with both local tissue destruction and systemic inflammatory responses. Non-surgical periodontal therapy, particularly scaling and root planing (SRP), is the primary treatment approach; however, it may not completely eliminate pathogenic microorganisms in all cases.
Adjunctive antimicrobial agents may improve treatment outcomes by enhancing bacterial reduction and modulating inflammation. Chlorhexidine (CHX) is widely used for its antimicrobial properties, while zinc has anti-inflammatory and immunomodulatory effects. The combined use of CHX and zinc may provide synergistic benefits in periodontal therapy.
The aim of this randomized controlled clinical trial is to evaluate the clinical and biochemical effects of CHX and zinc as adjuncts to SRP in individuals with stage I and II periodontitis.
A total of 44 systemically healthy participants will be randomly assigned to two groups. The test group will receive SRP with CHX and zinc, while the control group will receive SRP with distilled water. Clinical periodontal parameters (Plaque Index, Bleeding on Probing, Probing Pocket Depth, and Clinical Attachment Level) and biochemical markers (C-reactive protein, high-sensitivity CRP, Oncostatin M, and Antistreptolysin O) will be evaluated at baseline, 1 month, and 3 months.
The results of this study are expected to provide evidence regarding the potential benefits of CHX and zinc in improving periodontal treatment outcomes and reducing systemic inflammation.
详细描述
Periodontitis is a multifactorial chronic inflammatory disease characterized by the destruction of tooth-supporting tissues, including gingiva, periodontal ligament, and alveolar bone. It is initiated by microbial dental plaque and modulated by the host immune response, leading to both local tissue damage and systemic inflammatory effects.
Scaling and root planing (SRP) is the gold standard for non-surgical periodontal therapy and aims to mechanically remove plaque and calculus from root surfaces. However, due to anatomical limitations and microbial persistence in periodontal pockets, SRP alone may not always achieve optimal clinical outcomes. Therefore, adjunctive antimicrobial and anti-inflammatory agents have been proposed to enhance treatment efficacy.
Chlorhexidine (CHX) is considered the gold standard antiseptic in dentistry due to its broad-spectrum antimicrobial activity and substantivity. Zinc, on the other hand, has been shown to possess anti-inflammatory, antioxidant, and immunomodulatory properties. The combination of CHX and zinc may provide a synergistic effect by reducing microbial load while simultaneously modulating the host inflammatory response.
This study is designed as a single-center, randomized, controlled, prospective clinical trial conducted at the Department of Periodontology, Faculty of Dentistry, Ataturk University. A total of 44 systemically healthy individuals aged between 18 and 65 years with stage I and II periodontitis will be included.
Participants will be randomly allocated into two groups using a coin-toss method:
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 is blinded to group allocation. The operator performing the treatment is aware of the intervention, while participants are not explicitly informed about 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 between 18 and 65 years
- •Systemically healthy individuals
- •Diagnosed with Stage I or Stage II periodontitis according to the 2017 classification
- •Having probing pocket depth ≤5 mm and clinical attachment loss ≤4 mm
- •Having a sufficient number of teeth for periodontal evaluation
- •Willing to participate and able to provide informed consent
排除标准
- •Presence of systemic diseases affecting periodontal health
- •Pregnancy or breastfeeding
- •Use of antibiotics or anti-inflammatory drugs within the last 6 months
- •History of periodontal treatment within the last 6 months
- •Fewer than 15 teeth present
- •History of radiotherapy or chemotherapy
研究组 & 干预措施
Chlorhexidine-Zinc Adjunctive SRP
Participants receive scaling and root planing with adjunctive chlorhexidine and zinc.
干预措施: Chlorhexidine and zinc application (Procedure)
SRP with Distilled Water
Participants receive scaling and root planing (SRP) using an ultrasonic device with distilled water.
干预措施: Scaling and root planing with distilled water (Procedure)
结局指标
主要结局
Probing Pocket Depth (PPD)
时间窗: Baseline, 1 month, and 3 months
Measurement of periodontal pocket depth in millimeters to evaluate clinical periodontal improvement.
Clinical Attachment Level (CAL)
时间窗: Baseline, 1 month, and 3 months
Assessment of clinical attachment level in millimeters as an indicator of periodontal tissue healing.
次要结局
- Plaque Index (PI)(Baseline, 1 month, and 3 months)
- Bleeding on Probing (BOP)(Baseline, 1 month, and 3 months)
- 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