Efficacy of Locally Delivered Minocycline in Advanced Periodontitis. A Clinico-microbiological Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in Probing pocket depth (PPD)
研究概览
简要总结
Local drug delivery provides higher concentrations in the availability of the drug at the specific infected sites with the advantage of sustained release. Periocline is a long acting , sustained release local drug delivery system consisting of 2% minocycline hydrochloride in an ointment containing microcapsule type particles. Periocline contains 20mg of minocycline in 0.5 gm of gel in a disposable polypropylene applicator (2% minocycline HCl).
Research has yielded promising results with the local application of minocycline in the treatment of periodontal disease, compared with other non-surgical therapies. However, there is scarcity of reports on the use of local delivery agents with respect to new range of putative pathogens in advanced periodontitis, wherein the tissue invasive anaerobic organisms are present and possibly compromised host response, hence resulting in an exaggerated breakdown of periodontal tissues at the affected sites. The effect of Minocycline on new putative pathogens, such as Filifactor alocis and oral phylotypes of phyla Synergistetes and TM7 (referred to hereafter as oral Synergistetes and oral TM7s), has not been investigated yet.
Hence, the aim of the present study is to evaluate the efficacy of a local delivery agent containing minocycline (Periocline, Sunstar, Japan) as an adjunct to SRP in the treatment of deep periodontal pockets around teeth in advanced periodontitis and the antimicrobial effect on the red complex and the new putative pathogens.
详细描述
The subjects for this randomized controlled, parallel arm study will be selected from the primary health care in the Faculty of Dentistry, MAHSA University. In this clinical trial, 50 patients with advanced periodontitis will be enrolled in the study.
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 (Participant, Investigator)
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •systematically healthy patients with age range between 20- 60 years,
- •diagnosed with untreated Advanced Periodontitis with a pocket depth ≥6mm around two or more teeth, in two or more quadrants.
排除标准
- •Patients given antibiotics or anti-inflammatory drugs in the past 6 months,
- •allergic to tetracycline,
- •pregnant or nursing females,
- •those using chlorhexidine or any other mouth rinse
研究组 & 干预措施
Minocycline
Minocycline gel
干预措施: Minocycline Hydrochloride (Drug)
Placebo
Similar gel without the active agent
干预措施: Minocycline Hydrochloride (Drug)
结局指标
主要结局
Change in Probing pocket depth (PPD)
时间窗: baseline to 12 weeks
Periodontal pocket is measured from the gingival margin to the base of the periodontal pocket using a UNC periodontal probe (which is graduated from 1mm to 15mm). The measurement of periodontal pocket depth is a continuous scale. PPD is taken at 6 points on each tooth. The mean of the PPD will be obtained for each patient and subjected to statistical analysis.
Change in the numbers of Periodontal pathogens
时间窗: baseline to 12 weeks
Plaque samples taken from periodontal pockets on paper points will be first stored and later analysed for the presence and number of periopathogens using quantative Polymerase Chain Reaction (q-PCR). The following periodontal pathogens will be assessed: * Red complex (Porphyromonas gingivalis, Tannerella forsythia,and Treponema denticola) * Filifactor alocis, * oral phylotypes of phyla Synergistetes * Phylum TM7
Clinical Attachment Levels (CAL)
时间窗: baseline, 6 weeks and 12 weeks
change in CAL
次要结局
- Plaque Index(baseline to 12 weeks)
- Bleeding Index(baseline to 12 weeks)
研究者
Professor. Dr. Tara Bai Taiyeb Ali
Professor
Mahsa University