Immune Response After Periodontal Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Serum CRP
研究概览
简要总结
Primary Objective:
To identify changes in systemic markers of inflammation following periodontal treatment, comparing two standard treatment modalities (hands scaling and ultrasonic scaling)
Secondary Objectives:
To investigate bacteraemia, composition and function of oral bacteria, treatment outcomes following periodontal treatment, patient and operator preferences, and treatment time comparing hand scaling and ultrasonic scaling.
详细描述
Effective root surface debridement (RSD) is essential for successful periodontal treatment. Myriad studies demonstrate that RSD may be carried out using hand or ulstrasonic instruments with equal efficacy. Locally, effective debridement results in reduced inflammation in the gingival tissues, ultimately preserving the dentition. Systemically, RSD results in an immediate inflammatory response with elevated C-reactive protein (CRP), and cytokines (e.g. interleukin-6 and Tumor Necrosis Factor) detectable in the serum. This systemic inflammation may relate to systemic dissemination of bacteria from the periodontal pockets into the circulation, during instrumentation. Bacteria are detectable in serum immediately after instrumentation. The incidence of the bacteraemia varies considerably between different studies, ranging from 13% of patients to 43% to 55%. These studies used different methods of instrumentation; Kinane et al used full mouth ultrasonic scale, Zhang et al used a mixture of hand and ultrasonic instruments, and Heimdahl et al used curettes only. Whilst tempting to speculate that ultrasonic instrumentation induces less bacteraemia than hand instrumentation, there is no direct comparison of the effect of ultrasonic instrumentation with hand instrumentation on post treatment systemic inflammation.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Both the patients and clinicians will remain blinded to the intervention until the intervention is carried out. Research personnel will remain blinded to specific patient allocation throughout the process through the means of patient barcodes. The key linking the barcodes to the patients will be available to the Chief Investigator. The intervention codes will only be available once the key analyses have taken place.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of signed, written, informed consent to participate
- •Men or women aged 18 years to 70 years inclusive
- •Periodontal disease requiring treatment at Glasgow Dental Hospital
排除标准
- •Known or suspected high risk for tuberculosis, hepatitis B or HIV infections
- •Require interpreter/non English language written material to understand and provide, or any other reason for being unable to provide written, informed consent
- •History of bleeding diathesis
- •Females using contraceptive methods.
- •Pregnant or lactacting females.
- •Reported diagnosis of any systemic illnesses including cardiovascular, renal, and liver diseases.
- •Any pharmacological treatment within 3 months before the beginning of periodontal treatment.
- •Specialist Periodontal treatment in the previous 6 months.
- •Patients who will not tolerate Ultrasonic instrumentation even with local anaesthesia.
结局指标
主要结局
Serum CRP
时间窗: 24 hours after treatment, day 7, day 90
Changes in serum CRP.
次要结局
- Immune analysis(day 1, 7 and 90 post treatment)
- Periodontal Probing depths(day 90)
- Periodontal loss of attachment(day 90)
- Bacteraemia analysis(Day 1, day 7, day 90 post intervention)
- Plaque Index(day 90)
- Blood pressure(day 1, 7 and 90 post treatment)
- Microbiome(Pre treatment and 24 hours after treatment)
- Inflammation analysis(Day 1, 7 and 90 post treatment)
- Gingivitis Index(day 90)
研究者
Michael Paterson
Honorary Clinical Lecturer in Restorative Dentistry
University of Glasgow