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临床试验/NCT03004196
NCT03004196已完成1 期

Comparison of Efficacy Of Probiotic Toothpaste and Chlorhexidine Mouthwash To Reduce Streptococcus Mutans in Plaque Around Orthodontic Brackets

Peoples University, Bhanpur, Bhopal1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2015年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
已完成
发起方
入组人数
30
试验地点
1
主要终点
Control Group/Probiotic Toothpaste/Chlorhexidine Mouthwash

研究概览

简要总结

Orthodontic appliance causes increase in plaque accumulation, especially around brackets, wires and attachments. Advances in orthodontics in recent time have led to improved quality of appliance and treatment procedures ultimately resulting in improvised standard of patient care.

These bacteria metabolize different kind of carbohydrates accumulated around orthodontic appliances and create acidic environment in the oral cavity leading to enamel demineralization around the brackets and white spot lesions.

This study was carried out to evaluate and compare the efficacy of probiotic toothpaste and chlorhexidine mouthwash in patients undergoing orthodontic treatment with individuals who are not using them.

详细描述

INTRODUCTION - When the basic oral hygiene is poor, orthodontic appliances create areas where plaque gets accumulated, especially around brackets, bands, wires, and other attachments; this facilitates the development of white spot lesions. Probiotics act by competitively inhibiting the pathogenic bacteria because they have greater adhesion to the tissues while Chlorhexidine is often used as an active ingredient in mouthwash designed to reduce dental plaque around orthodontic appliances. AIM & OBJECTIVE - The objectives of the study is to evaluate and compare the effects of the topical application of probiotic toothpaste and chlorhexidine mouthwash on the Streptococcus Mutans levels in the plaque of orthodontic patients hence improving the oral micro-flora of oral cavity by competitive inhibition of Streptococcus Mutans in plaque present around brackets.

MATERIAL & METHOD - The study consists of thirty randomly selected orthodontic patients undergoing fixed appliance treatment. The patients were divided into three groups - Control Group (Group 1), Probiotic Toothpaste Group (Group 2) & Chlorhexidine Mouthwash Group (Group 3). Samples were collected at two times interval: before the study began (Phase 1) and after thirty days (Phase 2).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Participant)

入排标准

年龄范围
15 Years 至 30 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Orthodontic Treatment With The Straight Wire Appliance (MBT, 0.022-in Slot; 3M Unitek, Monro- Via, Calif), Permanent Dentition (Excluding Third Molars)
  • Good General Health (No Significant Medical History Or Drug Use During The Last Month)
  • No Anti-inflammatory Or Antibiotic Medications Taken In The Month Before The Study
  • No Chewing Gum Or, Mouthwash Used In The Last Week And During The Study
  • Habit Of Brushing Twice Daily With Fluoride Toothpaste

排除标准

  • Patient with poor periodontal condition Patient with known medical condition e.g. Subacute bacterial, endocarditis , diabetes, valvular disease ,anaemia etc

研究组 & 干预措施

Control Group

Active Comparator

They were not given probiotic toothpaste or chlorhexidine mouthwash

干预措施: Control Group (Other)

Probiotic Group

Experimental

Patients were asked to brush twice daily with given "G.D Probiotic Toothpaste" and were asked not to eat or drink anything for half-an-hour.

干预措施: Probiotic Toothpaste (Drug)

Chlorhexidine Mouthwash Group

Experimental

Patients were asked to rinse daily with "Dr. Reddy's Clohex" chlorhexidine mouthwash of 10ml without dilution for three times a day after meals (Breakfast, Lunch Dinner) for 3-4 minutes and were asked not to eat or drink anything for half-an-hour.

干预措施: Dr. Reddy's Clohex (Drug)

结局指标

主要结局

Control Group/Probiotic Toothpaste/Chlorhexidine Mouthwash

时间窗: 1 Month

Probiotic Toothpaste \& Chlorhexidine Mouthwash Reduced S.mutans when compared to Control Group

次要结局

未报告次要终点

研究者

发起方
Peoples University, Bhanpur, Bhopal
申办方类型
Other
责任方
Principal Investigator
主要研究者

Chandrika Dubey

Post-Graduate Student

Peoples University, Bhanpur, Bhopal

研究点 (1)

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