Antimicrobial Efficacy of Xylitol, Probiotic and Chlorhexidine Mouth Rinses Among Children and Elderly Population at High Risk for Dental Caries - A Double Blind Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change in Streptococcus Mutans Levels in Dental Plaque
研究概览
简要总结
Dental caries is a localized, post eruptive pathological process involving softening of the hard tooth tissue and proceeding to the formation of cavity. It results from accumulation of plaque on the surface of the teeth and biochemical activities of complex microorganisms. Streptococcus mutans is one of the main pathogens of dental caries. Although brushing has the potential to maintain adequate levels of oral hygiene, studies demonstrate that such methods are not being employed sufficiently. The need for additional help in controlling bacterial plaque provides the rationale for patients using mouth rinses as adjuncts. Chlorhexidine although considered the gold standard, its side effects due to prolonged use such as staining of teeth, dry mouth, altered taste sensation, mouth/ throat irritation, etc indicates the need for alternatives.
Probiotics are live microorganisms that, when administered in adequate amounts, confer a health benefit on the host. Probiotic technology represents a breakthrough approach to maintaining oral health by utilizing natural beneficial bacteria commonly found in healthy mouths to provide a natural defense against those bacteria thought to be harmful to teeth and gums. The advantages of using a probiotic mouth rinse are that it contains friendly microbes, there is no issue of antibiotic resistance, and there are no known/proven toxicities caused due to their use.
Xylitol is a non-sugar sweetener permitted for use in foods. Xylitol is a naturally occurring non-cariogenic sugar substitute that cannot be metabolized by oral bacteria. This possesses various properties favorable for caries prevention.It acts by forming of loosely attached biofilms on the tooth surfaces that can be easily removed. Although many studies have evaluated the effects of xylitol chewing gum on caries prevention, there are very few examining the effect of xylitol mouth rinse on oral Streptococcus mutans. Hence xylitol mouth rinse may be introduced as a possible alternative.
Antimicrobial efficacies of probiotics and xylitol mouth rinses have not been compared till date. Also their effects on the young and elderly population have not been compared. Hence the purpose of the study is to compare the antimicrobial efficacies of probiotic & xylitol mouth rinses with that of chlorhexidine in children and elderly population.
详细描述
Need for the study:
World Health Organization defines dental caries as a localized, post eruptive pathological process of extreme origin involving softening of the hard tooth tissue and proceeding to the formation of cavity. The process involves bacterial interactions in plaque accumulated on the surface of the teeth. Streptococcus mutans in plaque is the most commonly isolated organism amidst all other cariogens. It ferments sucrose and the resulting acid causes demineralization of tooth enamel.
While mechanical methods of plaque control can maintain adequate oral hygiene, such methods are not being utilized appropriately by the population. This necessitates use of adjuncts to mechanical plaque control methods in the form of antiplaque mouth rinses. Chlorhexidine mouth rinse has been considered the most effective agent in inhibiting Streptococcus mutans. Although considered the gold standard, its adverse effects due to prolonged use such as staining of teeth, xerostomia, altered taste sensation, mouth/ throat irritation, antimicrobial resistance, etc. indicates the need for alternatives which have been extensively studied of late in literature.
Xylitol used as an artificial sweetener in foods, is a non-cariogenic sugar substitute. This polyalcohol cannot be metabolized by oral bacteria thereby preventing caries. The magnitude of adverse effects caused by xylitol as compared to that of Chlorhexidine is indistinct. Although studies have assessed effects of xylitol chewing gum on caries, very few have studied its efficacy as a mouth rinse.
Probiotics are live microorganisms that, when administered in adequate amounts, confer a health benefit on the host. Probiotic products seem to have an effect on the oral health of individuals by prompting beneficial bacteria to defend teeth and gums against harmful ones. The advantages of probiotics as compared to that of chlorhexidine mouth rinse are that there are no issues of antibiotic resistance as it contains only commensal flora and there has been no proof of intoxication or allergies on consumption.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 5 Years 至 90 Years(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children aged 5-12 yrs at high risk for caries.
- •Elderly citizens (above 60 yrs) at high risk for caries.
- •Those willing to participate in the study and consented.
- •Not under antimicrobial therapy or used probiotic products during past 1 month.
排除标准
- •Using mouth rinse routinely.
- •Undergoing any dental treatment during the study period.
- •Not able to brush their teeth and rinse on their own.
研究组 & 干预措施
Child Participants
Residential school children aged 5-12 yrs at high risk for caries. A total of 36 children will be recruited for the study and randomly divided into 3 groups with 12 participants per group.The subjects will be asked to rinse their mouth once daily (at night) for 2 minutes, using 15 ml of mouth rinse provided to them. The intervention will be carried out for a period of 14 days.
干预措施: Chlorhexidine mouthwash (Drug)
Child Participants
Residential school children aged 5-12 yrs at high risk for caries. A total of 36 children will be recruited for the study and randomly divided into 3 groups with 12 participants per group.The subjects will be asked to rinse their mouth once daily (at night) for 2 minutes, using 15 ml of mouth rinse provided to them. The intervention will be carried out for a period of 14 days.
干预措施: Xylitol (Drug)
Child Participants
Residential school children aged 5-12 yrs at high risk for caries. A total of 36 children will be recruited for the study and randomly divided into 3 groups with 12 participants per group.The subjects will be asked to rinse their mouth once daily (at night) for 2 minutes, using 15 ml of mouth rinse provided to them. The intervention will be carried out for a period of 14 days.
干预措施: Probiotic (Drug)
Elderly Participants
Elderly citizens (above 60 yrs) at high risk for caries. A total of 36 elderly will be chosen based on eligibility criteria and randomly divided into 3 groups with 12 participants per group. The subjects will be asked to rinse their mouth once daily (at night) for 2 minutes, using 15 ml of mouth rinse provided to them. The intervention will be carried out for a period of 14 days.
干预措施: Chlorhexidine mouthwash (Drug)
Elderly Participants
Elderly citizens (above 60 yrs) at high risk for caries. A total of 36 elderly will be chosen based on eligibility criteria and randomly divided into 3 groups with 12 participants per group. The subjects will be asked to rinse their mouth once daily (at night) for 2 minutes, using 15 ml of mouth rinse provided to them. The intervention will be carried out for a period of 14 days.
干预措施: Xylitol (Drug)
Elderly Participants
Elderly citizens (above 60 yrs) at high risk for caries. A total of 36 elderly will be chosen based on eligibility criteria and randomly divided into 3 groups with 12 participants per group. The subjects will be asked to rinse their mouth once daily (at night) for 2 minutes, using 15 ml of mouth rinse provided to them. The intervention will be carried out for a period of 14 days.
干预措施: Probiotic (Drug)
结局指标
主要结局
Change in Streptococcus Mutans Levels in Dental Plaque
时间窗: Assessment of change in Streptococcus mutans levels 14 days after intervention
Change in Streptococcus mutans levels in dental plaque after using mouth rinses for 14 days to determine their antimicrobial efficacy.
次要结局
未报告次要终点
研究者
Dr. Krupa NC
Principal Investigator
JSS Dental College And Hospital
