The Adjunctive Effect of Probiotics to Non Surgical Treatment of Chronic Periodontitis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Change in Probing pocket depth
研究概览
简要总结
Evaluation of clinical and microbiological effect of lactobacillus reuteri probiotics.
详细描述
The present randomized controlled clinical trial was conducted to evaluate the effects of Lactobacillus reuteri-containing probiotic suspension as an adjunct to scaling and root planing (SRP).
Material and Methods
Twenty sites from twelve chronic periodontitis patients were recruited and monitored clinically and microbiologically at baseline, three, and six months after therapy for plaque index (PI), bleeding on probing (BOP), probing pocket depth (PPD) and clinical attachment level (CAL) and microbiologically or Porphyromonas gingivalis (P. gingivalis) load. Patients meeting the inclusion criteria were scheduled within one week for two sessions of SRP performed using ultrasonic scalers and hand instrumentation. After SRP, oral hygiene measures were reassured and then sites were randomly allocated to one of the two groups 10 sites each. group I (SRP only) and group II (SRP + probiotic). Group II received SRP and sub-gingival delivery of 1ml of probiotic L. reuteri suspension at baseline (immediately after SRP), one, two and four weeks using blunt syringe. Periodontal dressing was applied after placement of the drug.
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
- 35 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with good systemic health.
- •Patients with moderate chronic periodontitis with attachment level ranging from 3-4 mm.
- •Optimal compliance as evidenced by no missed treatment appointments and positive attitude towards oral hygiene.
- •No gingival recession.
排除标准
- •Patients with history of antibiotic, anti-inflammatory drugs or periodontal therapy in the preceding 6 months.
- •Patients with risk factors (e.g. - smoking, uncontrolled diabetes, uncontrolled hypertension, pregnant or any other systemic disease which can alter the course of periodontal therapy).
- •Patients who are allergic to lactate products.
研究组 & 干预措施
Placebo group
patients received scaling and root planing using hand and ultrasonic instruments.
干预措施: Scaling and root planing (Procedure)
Probiotic group
patients received SRP and by using blunt syringe, subgingival delivery of 1ml of probiotic suspension was applied to these sites at baseline (immediately after SRP), one, two and four weeks. Periodontal dressing was applied after placement of the drug.
After placement of the drug, patients were instructed to keep away from chewing hard or sticky food, brushing near the treated areas, or using any interdental aids for 24 hours.
干预措施: Lactobacillus Reuteri Oral Drops (Drug)
Probiotic group
patients received SRP and by using blunt syringe, subgingival delivery of 1ml of probiotic suspension was applied to these sites at baseline (immediately after SRP), one, two and four weeks. Periodontal dressing was applied after placement of the drug.
After placement of the drug, patients were instructed to keep away from chewing hard or sticky food, brushing near the treated areas, or using any interdental aids for 24 hours.
干预措施: Scaling and root planing (Procedure)
结局指标
主要结局
Change in Probing pocket depth
时间窗: Baseline. 3 months. 6 months
Individual acrylic stents were prepared to serve as the constant points to align the probe consistently and to reduce errors associated with probe placement. Probing pocket depth was assessed using a manual probe (UNC-15). The distance from the free gingival margin to the bottom of the pocket was recorded at six sites for each examined tooth. The probe was inserted in line with the long axis of the tooth and walked circumferentially around each surface of each tooth to detect and record the area of the deepest probe penetration. The mean probing pocket depth was obtained by summing the scores for the six sites and dividing it by six.
次要结局
- Change in Clinical attachment level(Baseline, 3 and 6 months)
- Change in Plaque index(Baseline, 3 and 6 months)
- Change in Bleeding on probing(Baseline, 3 and 6 months)
研究者
Ghadeer Khalil Elbagoory
Demonstrator
Tanta University