The Effect of Non-surgical Periodontal Therapy on Host Response and Microbiological Profile of Type 2 Diabetics With Periodontal Disease.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Effect of periodontal intervention on plaque score levels in diabetics with periodontal disease
研究概览
简要总结
Periodontitis, a chronic inflammatory disease which results in irreversible attachment loss, bone destruction and tooth loss, is a major oral health problem affecting 90.2% of Malaysian population. It was initially demonstrated that Type 2 Diabetes (T2D) was a risk factor for periodontitis and subsequently a two-way relationship between diabetes and periodontitis was proposed. Diabetes has been shown to cause defects in neutrophil function by overproduction of pro-inflammatory mediators such as Tumour necrosis factor-α, Interleukin-1β and Prostaglandin E2 by macrophages. The inflammatory mediators released in response to plaque have been reported to be insulin antagonists that disturb binding of insulin to its receptors and further complicate hyperglycaemia in T2D. The hyperglycaemia in diabetics promotes more pathogenic bacteria into the subgingival microenvironment making them more susceptible to chronic periodontitis. Studies however differ in the types of periodontal pathogens present in these pockets. At the same time, very few studies have quantified them. This study proposes to investigate the effect that non-surgical periodontal therapy (NSPT) has on the periodontal parameters, HbA1c levels, microbiological profile and CRP levels of T2D patients with chronic periodontitis as compared to oral hygiene education (OHE)alone.
详细描述
Ethical approval was obtained from both the Medical Ethics Boards of University Malaya Medical Centre (MEC Ref No: 696.9) and University Malaya Dental Centre [DF PE1002/0045(P)]. One hundred and twelve type 2 diabetic patients (diagnosed at least 1 year prior to the study) between ages of 30 to 70 were screened from the outpatient Diabetes Clinic of the University Malaya Medical Centre and a total of 40 patients who fulfilled the inclusion and exclusion criteria were recruited for the study. The recruited patients were then registered at the Periodontology Clinic at the Faculty of Dentistry, University of Malaya. Patient information sheets regarding the study and verbal explanations were given to all patients. Informed consent was obtained from all recruited patients with the understanding that they could withdraw from the study at any time. Screening and treatment of patients commenced from January 2010 till December 2011.
The sample size calculation determined that 15 subjects per treatment arm would provide 80% power to detect a minimum difference of 1% (11.0 mmol/mol) change in HbA1c between test and control. Accordingly, a sample of 20 subjects per arm (40 in total) was recruited to compensate for possible drop-outs during the study period.
All patients were randomly assigned via a coin toss to age matched NSPT and OHE groups. Investigator 1 screened and enrolled participants and assigned them to age-matched groups. Investigator 2 performed the random allocation sequence using coin toss method to assign participants to the different interventions while Investigator 1 performed all intervention. There was no blinding of participants or examiner.
As only one examiner was involved in the study, intra-examiner reliability assessment was executed to validate the ability of the examiner to constantly reproduce the quantitative outcome measurements of the clinical parameters used. The Plaque Index (PI), Gingival Bleeding Index (GBI), Probing Pocket Depth (PPD) and Probing Attachment Loss (PAL) were measured in the time interval of about 3 hours. Utilizing Kappa statistics, good agreements (>0.8) were obtained for reproducibility of all recorded clinical parameters.
All recruited patients underwent full periodontal assessment at baseline, 2 months after assigned treatment and 3 months after assigned treatment. The clinical examination included Plaque Index (PI), Gingival Bleeding Index (GBI), Probing Pocket Depth (PPD) and Probing Attachment Loss (PAL) measured with an electronic constant- force probe (Florida Probe®).
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
- None
入排标准
- 年龄范围
- 30 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 Diabetes Mellitus patients whose diagnosis had been established (World Health Organization, 1999) and were on regular follow-ups for a minimum of 6 months.
- •Patients should have at least 12 teeth present
- •Patients with 2 or more interproximal sites (not on same tooth) with probing pocket depths of 5mm or more and 2 or more interproximal sites (not on same tooth)of probing attachment loss of 4mm or more which bled on probing.
排除标准
- •Patients who had history of systemic antibiotic usage over the previous 4 months
- •Patients who were pregnant
- •Patients who had received non-surgical periodontal treatment within the past 6 months
- •Patients who had received surgical periodontal treatment within the past 12 months
- •Patients who were smokers
- •Patients with a history of stroke or an acute cardiovascular event over the previous 12 months.
- •Patients who had their diabetic medication changed during the course of the study
结局指标
主要结局
Effect of periodontal intervention on plaque score levels in diabetics with periodontal disease
时间窗: Changes from baseline to 3 months
Plaque score levels were evaluated at baseline, 2- and 3-months intervals
Effect of periodontal intervention on gingival bleeding index of diabetics with periodontal disease
时间窗: Changes from baseline to 3 months
Gingival bleeding index levels were evaluated at baseline, 2- and 3-months intervals
Effect of periodontal intervention on probing pocket depths of diabetics with periodontal disease
时间窗: Changes from baseline to 3 months
Probing pocket depths were evaluated at baseline, 2- and 3-months intervals
Effect of periodontal intervention on probing attachment levels of diabetics with periodontal disease
时间窗: Changes from baseline to 3 months
Probing attachment levels were evaluated at baseline, 2- and 3-months intervals
次要结局
- Effect Of periodontal intervention on microbiological profile of diabetics with periodontal disease(Changes from baseline to 3 months)
- Effect of periodontal intervention on HbA1c levels of diabetics with periodontal disease(Changes from baseline to 3 months)
- Effect Of periodontal intervention on hs-CRP levels in diabetics with periodontal disease(Changes from baseline to 3 months)
研究者
Dr Rathna Devi Vaithilingam
Dr
University of Malaya