Three-Session Non-Surgical Periodontal Therapy Improves Biochemical and Microbiological Profiles in Patients With Severe Grade C Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Change in Full-Mouth Mean Probing Depth (PD)
研究概览
简要总结
This clinical study investigates two different non-surgical periodontal therapy approaches in patients with advanced periodontitis and compares them with periodontally healthy individuals. Participants with Stage III/IV Grade C periodontitis are randomly assigned to either a single-session or a three-session scaling and root planing (SRP) protocol. Clinical parameters, gingival crevicular fluid inflammatory markers, and subgingival microbial profiles are assessed at baseline and during a 6-month follow-up period. The study aims to determine whether performing non-surgical periodontal therapy in multiple sessions influences clinical, biochemical, and microbiological responses.
详细描述
This randomized, single-blinded, controlled clinical trial is conducted at the Department of Periodontology, School of Dentistry, Ege University, İzmir, Turkey. The purpose of the study is to evaluate whether a three-session non-surgical periodontal therapy protocol provides different clinical, biochemical, and microbiological responses compared to a single-session protocol in patients with Stage III/IV Grade C periodontitis.
Participants with periodontitis are randomly assigned to one of two intervention groups:
Single-Session Therapy Group (SSTG): full-mouth scaling and root planing (SRP) performed in one visit.
Three-Session Therapy Group (TSTG): quadrant-wise SRP delivered over three sessions within the same week.
All procedures are carried out by a single calibrated clinician. Clinical periodontal parameters-probing depth, clinical attachment level, plaque index, and bleeding on probing-are recorded at baseline and at predetermined follow-up visits at 1, 3, and 6 months.
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
Single-blinded design: Outcome assessors were blinded to treatment allocation, while participants and care providers were aware of the assigned intervention.
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
- 是
入选标准
- •Systemically healthy, non-smoking individuals aged 18-65 years
- •Diagnosis of Stage III or IV Grade C periodontitis according to the 2018 classification of periodontal diseases
- •Presence of at least 20 teeth
- •No periodontal treatment within the previous 6 months
- •Willingness to participate and provide written informed consent
排除标准
- •Presence of systemic diseases or conditions affecting the periodontium (e.g., diabetes mellitus, cardiovascular diseases, immunological disorders)
- •Pregnancy or lactation
- •Use of antibiotics, anti-inflammatory, or immunosuppressive drugs within the past 3 months
- •History of periodontal therapy or surgery within the last 6 months
- •Smoking or use of any tobacco products
结局指标
主要结局
Change in Full-Mouth Mean Probing Depth (PD)
时间窗: Baseline to 6 months
Mean change in probing depth (in millimeters) measured at six sites per tooth from baseline to 6 months.
次要结局
- Change in Clinical Attachment Level (CAL)(Baseline, 1 month, 3 months, and 6 months after treatment)
- Change in Bleeding on Probing (BOP)(Baseline, 1 month, 3 months, 6 months)
- Change in Plaque Index (PI)(Baseline, 1 month, 3 months, 6 months)
- Change in Gingival Crevicular Fluid Biomarker Levels (Clusterin, Cystatin C, IL-1β, IL-6, and Osteocalcin)(Baseline, 1 month, 3 months, and 6 months after treatment)
- Change in Subgingival Microbiota Composition(Baseline, 1 month, 3 months, and 6 months after treatment)
研究者
Gülnur Emingil
Principal Investigator
Ege University