A Randomized control trial evaluating the efficacy of probiotics in treatment of halitosis in chronic periodontitis patient : A clinico microbiological study
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Expecting reduction in number of anaerobic bacteria and halitosis
研究概览
简要总结
Periodontitis is a chronic inflammatory disease that affects thesupporting structures of teeth, resulting in tooth loss. Halitosis (fetor oris) is a general term used to describe an unpleasant or offensive odouremanating from the oral cavity. Periodontal disease results in an unpleasantodour
Probiotics are “live microorganismswhich when administered in adequate amounts confer a health benefit on thehost†(WHO 2002). In oral cavity, probiotics can create a biofilm, acting as aprotective lining for oral tissues against oral diseases.
This study evaluates the efficiencyof probiotics in preventing halitosis in chronic periodontitis patients.
A total number of 26 cases of chronicperiodontitis with halitosis will be selected randomly by self-evaluation(problematic, very strong, strong, moderate, light) and organoleptic method (0-5point score) and willbe divided in to test group A(SRP+ Probiotics) and control group B (SRP+Placebo) including both males and females in the age group of 20-70 years. The study will be explained to each of thepatients selected randomly and his/her written consent will be obtained priorto the commencement of the study. After qualifying for the study, 5 clinical variables will beevaluated at the baseline by the examiner who will be recording allmeasurements in a single blind design including probing pocket depth (PPD),clinical attachment level (CAL), sulcus bleeding index (SBI), Periodontal index(PI), wrinkel tongue coating index (WTCI) .After the initial clinical evaluationsubgingival samples will be collected byinserting two consecutive paper points in to gingival crevices for 10 seconds.Then the samples will be given for the analysis of microbiological data, colonyforming unit (CFU) per ml for total anaerobic flora .After the samplecollection scaling and root planing will be done on both groups. The patientsin group A will be advised to use probiotic tablets and group B will be givenplacebo. Patient will be recalled 4weeks and 8weeks after initial scaling and root planning andthe above measurements will be repeated and samples are collected at 1st and3rd months and given for microbiological investigation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Subjects with a minimum complement of 20 teeth.
- •2.systemically healthy patients 3.patient diagnosed with chronic periodontitis clinically evident with at least 2 teeth 4.showing probing depth ≥5mm 5.patient with clinically perceptible halitosis.
排除标准
- •1.Subjects with any systemic disease.
- •2.Subjects received periodontal treatment in last 6 months 3.Subjects who have received antibiotics/anti-inflammatory drugs/steroids in the recent past 4.Pregnant or lactating women.
- •5.Subjects who are tobacco users.
- •6.Patients allergic to lactate products 7.Patient deemed uncooperative.
结局指标
主要结局
Expecting reduction in number of anaerobic bacteria and halitosis
时间窗: baseline, 1 month and 6 month
次要结局
- gradual reduction in number of anaerobic bacteria and there by decrease in halitosis(baseline, 1 month and 6 month)