Efficacy of Guided Biofilm Therapy (GBT) for Treatment of Deep Periodontal Pockets: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 25
- 主要终点
- Periodontal pocket depth (PPD)
研究概览
简要总结
the aim of the study is to evaluate the efficacy of guided biofilm therapy (GBT) for treatment of deep periodontal pockets.
the objectives are
1- To compare the change in the clinical periodontal parameters and microbiological parameters by using real time PCR for P. gingivalis, Aggregatibacter actinomycetemcomitans and Filifactor alocis among sites treated by GBT and conventional hand instrumentation after a period of 3 months and to assess the level of the selected periodontal pathogens in deep periodontal pockets and to estimate and compare deep periodontal pockets which need surgery after 3 months of non-surgical treatment by GBT and conventional hand instrumentation.
the hypothesis is whether there are no differences in in the clinical and microbiological parameters among sites treated by GBT and conventional hand instrumentation after a period of 3 months or there are differences in in the clinical and microbiological parameters among sites treated by GBT and conventional hand instrumentation after a period of 3 months.
The participants will be selected on a consecutive basis from patients referred to the Department of Periodontics, College of Dentistry, University of Baghdad.
For each patient, each site will be randomly assigned to either treatment protocol:
- Sites treated with GBT.
- Sites treated with conventional manual instrumentation only.
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)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients, aged more than 18 years.
- •No history of any systemic diseases.
- •Diagnosed with Stages 3 and 4 periodontitis according to the 2017 World Workshop on the Classification of Periodontal disease.
- •The presence of deep periodontal pocket ≥ 6 mm in two non-adjacent teeth.
排除标准
- •Pregnant and lactating mothers.
- •History of any previous subgingival instrumentation in the last 3 months.
- •The use of antibiotics/non-steroidal anti-inflammatory drugs in the last 3 months.
- •Regular use of medication to control systemic illness.
- •The presence of perio-endo lesion.
研究组 & 干预措施
guided biofilm therapy group
Sites treated with guided biofilm therapy.
干预措施: guided biofilm therapy (Procedure)
conventional root debridement group
Sites treated with conventional manual instrumentation only.
干预措施: root surface debridement (Procedure)
结局指标
主要结局
Periodontal pocket depth (PPD)
时间窗: 3 months
PPD will be measured from the gingival margin to the base of the pocket by using the University of North Carolina 15 probe (UNC15) probe to measure the reduction of the pocket depth in millimeters.
次要结局
- Relative attachment level(3 months)
- Bleeding on probing(3 months)
- Changes in the bacterial load(3 months)
- Plaque index(3 months)
研究者
Reem Hussain Faisal
dentist
University of Baghdad