Clinical and Microbiological Efficacy of Chloramine and Hyaluronic Acid Gels in Non-surgical Periodontitis Treatment: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Probing depth (PD) reduction
研究概览
简要总结
The aim of the study is to investigate clinical and microbiological effects of subgingival application of chloramine (Perisolv) and hyaluronic acid (Hyadent BG) gels as adjuncts to scaling and root planing in non-surgical periodontitis treatment.
详细描述
Objectives:
- To evaluate if additional subgingival delivery of chloramine and hyaluronic acid gels would enhance clinical outcomes of scaling and root planing in periodontitis patients.
- To assess if additional subgingival delivery of chloramine and hyaluronic acid gels would reduce total counts of periodontopathogenic bacteria compared to scaling and root planing alone.
The treatment will consist of two treatment modalities: (1) Control group - full mouth scaling and root planing (SRP) (2) Test group - full mouth SRP + "Perisolv"+ Hyadent BG gels.
The periodontal treatment will be performed in one session without time restrictions. Under local anesthesia, an experienced operator, will perform a full mouth subgingival scaling and root planing with an ultrasonic device and Gracey curettes. Afterwards, all teeth will be polished using a low-abrasive paste.
Teeth in the test group (all teeth with PD ≥ 5 mm) will adjunctively be treated with chloramine gel (Perisolv), which will be inserted into periodontal pockets before and during SRP (2 times). The nozzle will be placed in the pocket mesially, lingually, distally and bucally. Teeth will be polished and all treated pockets will be filled with hyaluronic acid gel.
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
- Triple (Care Provider, Investigator, Outcomes Assessor)
盲法说明
Periodontal examination, microbiologic sampling and professional oral cleaning will be performed by the investigator, unaware of periodontal treatment. Periodontal treatment will be performed by the investigator, unaware of clinical examination. Microbiological analysis will be performed by a third investigator, masked from clinical measurements and periodontal treatment.
入排标准
- 年龄范围
- 30 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •> 30 years old;
- •Good general health according to medical history and clinical judgment;
- •Exhibiting at least one pocket in each quadrant with pocket depth (PD) ≥ 5 mm;
- •Radiographic evidence of bone loss ( > 2 mm from cemento-enamel junction (CEJ) );
- •Untreated periodontal disease;
- •Minimum 20 teeth (wisdom teeth excluded);
- •No removable prosthesis.
排除标准
- •Patients already included in other clinical trials;
- •Periodontal treatment during the last 12 months;
- •Antibiotic treatment 6 months prior to the start of the trial;
- •Antibiotic prophylaxis required for dental treatment;
- •Ongoing medication that may affect the clinical features of periodontitis;
- •Pregnant/lactating.
结局指标
主要结局
Probing depth (PD) reduction
时间窗: 6 months
PD (probing depth): the distance (mm) between the gingival margin and the bottom of the sulcus/pocket
次要结局
- Bleeding on probing (BOP)(6 months)
- Clinical attachment level (CAL)(6 months)
- Plaque Index (PI)(6 months)
- Reduction of total counts of periodontopathogenic bacteria(6 months)
研究者
Egle Ramanauskaite
pHd student
Lithuanian University of Health Sciences