Effect of Probiotic Along With Scaling and Root Planing in the Treatment of Chronic Periodontitis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in periodontal pocket depth (PPD)
研究概览
简要总结
This study will assess clinical and microbiological efficacy of probiotics and antibiotics in patients of chronic periodontitis as an adjunctive to scaling and root planing (SRP) in reducing bacterial count and in improving clinical periodontal parameters over the period of 12 weeks.Also the comparison between these adjunctives will be made for clinical assessment clinical periodontal parameters will be taken .these parameters plaque index (PI), gingival index (GI), clinical attachment loss (CAL) and pocket probing depth (PPD) for microbiological assessment plaque sample will be taken, DNA will be extracted and then sample will be processed through quantitative polymerase chain reaction (qPCR) for quantitative analysis of bacterial count of porphyromonas gingivalis.
详细描述
In this clinical trial total 60 participants of clinically diagnosed chronic periodontitis will be recruited after taking a written consent for their approval. Participants will be divided into 3 groups A, B and C through the process of randomization using a method of opaque sealed envelopes. A research assistant will be hired for the purpose of randomization and allocation concealment. All participants will be asked to pick an opaque envelope containing the details of treatment products. After randomization plaque sample will be obtained from the depth of periodontal pockets and all the clinical periodontal parameters will be recorded in every participant. Then all the participants will undergo SRP. After SRP group A will be given antibiotics Amoxicillin 500 milligrams (mg) for 3 times a day (TDS) and Metronidazole 400 milligrams (mg) for twice a day (BD) for 5 days. Group B will be given probiotics lactobacillus reuteri 1.2 billion colony forming unit (CFU) sachets twice daily for swallowing with water for 12 weeks. Group C will be given lactobacillus sachets of same amount and participant will be asked to mix it with little amount of water and apply it on teeth with the toothbrush twice daily after brushing with standard tooth paste for 12 weeks. Patients will be recalled at the interval of 3, 6, 9 and 12 weeks for the recording of clinical periodontal parameters. After completion of trial plaque sample will be taken again from every participant and will be processed through qPCR to check bacterial count of porphyromonas gingivalis before and after treatment. Whereas comparison between clinical periodontal parameters will be made at the interval of 0, 3, 6, 9, 12 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patients with clinically diagnosed chronic periodontitis with a pocket depth of ≥4mm.
- •Patients with age ≥30 years.
排除标准
- •Handicapped patients who are physically or mentally unable to maintain their oral hygiene.
- •Pregnant and lactating females.
- •Patients with habits of smoking, chewing tobacco and alcohol consumption.
- •Patients on local or systemic antibiotic treatment.
- •Patients with any systemic diseases.
- •Patients with the history of any periodontal therapy within last 6 months.
- •Patients undergoing orthodontic treatment.
研究组 & 干预措施
Local Probiotics
P Flor (Lactobacillus reuteri 1.2 billion CFU) will be delivered locally every 12 hours for 12 weeks
干预措施: P Flor locally delivered (Dietary Supplement)
Systemic Probiotics
P Flor (Lactobacillus reuteri 1.2 billion CFU) will be administered every 12 hours for 12 weeks
干预措施: P Flor systemically administered (Dietary Supplement)
Systemic Antibiotics
Amoxil 500 mg capsule and Flagyl 400 mg tablet by mouth, will be given every 8 hours for 5 days
干预措施: Amoxil 500 mg Oral Capsule (Drug)
Systemic Antibiotics
Amoxil 500 mg capsule and Flagyl 400 mg tablet by mouth, will be given every 8 hours for 5 days
干预措施: Flagyl 400 mg Tablet (Drug)
结局指标
主要结局
Change in periodontal pocket depth (PPD)
时间窗: Baseline, 3, 6, 9 and 12 weeks
It is the distance from tip of free gingival margin to the base of pocket
Change in clinical attachment level (CAL)
时间窗: Baseline, 3, 6, 9 and 12 weeks
It is the distance from cementoenamel junction to the base of the pocket around the tooth
Change in bacterial load of Porphyromonas gingivalis
时间窗: Baseline and 12 weeks after completion of trial
Bacterial count or the quantity of porphyromonas gingivalis in the sample
次要结局
- Change in the Plaque index (PI)(Baseline, 3, 6, 9 and 12 weeks)
- Change in Gingival index (GI)(Baseline, 3, 6, 9 and 12 weeks)
研究者
Sana Ikram, MPhil Trainee
Doctor, Lecturer, MPhil trainee
Ziauddin Hospital