Efficacy of Probiotics as an Adjunct to Scaling and Root Planing in Periodontitis: A Randomized, Double-Blind, Placebo-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 108
- 试验地点
- 1
研究概览
简要总结
This is randomized double blind placebo controlled three arm trial. individuals meeting eligibility criteria after ICF signing will be randomly allocated to either group1 receiving on chewable probiotic tablet containing Lactobacillus reutri UBLRu-87, twice daily for 84 days. Group 2 will receive one chewable probiotic tablet containing a blend of Streptococcus salivarius UBSS-01, Lactobacillus salivarius UBLSS-22, Lactobacillus plantarum UBLP-40, Lactobacillus reuteri UBLRu-87, Bacillus coagulans, fructo-oligosaccharides, elemental zinc (from zinc citrate), vitamin D3, taken twice daily for 84 days.Group 3 will receive one chewable placebo tablet identical in appearance to the probiotic tablets, taken twice daily for 84 days.There will be total 5 visits- Visit -1 (Day -1); Visit 2 (Day 0 -Baseline; Visit 3 (Day 28); Visit 4 (Day 56); Visit 5 (Day 84). The primary outcome measures will be changes in probing pocket depth (PPD) and clinical attachment level (CAL) following periodontal therapy in patients with moderate to severe periodontitis and halitosis. Secondary outcome measures will include bleeding on probing (BOP), gingival index (GI), plaque index (PI), Winkel Tongue Coating Index (WTCI), and levels of volatile sulfur compounds (VSCs) associated with halitosis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)(—)
- 性别
- All
入选标准
- •Three or more natural teeth required per quadrant, with third molar exclusion
- •Moderate to severe periodontitis with the PD more than or equal to 4mm.
排除标准
- •individuals who are on any probiotic supplements for the past 3 months
- •individuals who has received antimicrobial/ periodontal therapies in last 3 months.
- •Those who receive oral hygiene treatment.
- •Patients with dental emergencies requiring antibiotic therapy such as pain, abscess, etc
- •Patients with history of systemic disease, smoking, allergy to lactose and fermented milk products
- •Pregnant and lactating females or those planning pregnancy during the treatment period.
研究者
Dr Mehdi Ali Mirza
ESIC Medical College and Hospital
