跳至主要内容
临床试验/CTRI/2018/03/012632
CTRI/2018/03/012632已完成Unknown

To evaluate the effect of use of chewing gum containing 100% xylitol on mutans streptococci salivary levels among dental students in bangalore city - a randomised controlled trial.

The Oxford Dental College and Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年1月4日最近更新:

试验速览

阶段
Unknown
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
the action of 100% xylitol chewing gums at the dose and frequency used in our study in reduction of mutans streptococci and this strategy can be used as a targeted caries-preventive measure

研究概览

简要总结

This research marks a newbeginning to the evaluation of the effectiveness of 100% xylitol chewing gumson the salivary measures and oral micro flora which attribute to the cariespreventive action.

The major findings of our doubleblind parallel arm Randomized controlled trial were that the mean age of thestudy subjects was 19.45+/- 1.37 years. The salivary pH in Group I hadsignificantly increased after 30 days of intervention (5.83 to 6.62, p<0.05)as compared to the baseline but did not show a sustained effect at thefollow-up at 60 and 90 days.

The salivary buffering capacityalso significantly varied between the two groups after 30 days of interventionand had a sustained effect only upto 60 days follow-up period.

The results in our trial showedthat there was a difference in the salivary flow rate between the two groups at30 days of intervention (1.34 ml/minute to 2.46 ml/minute), but at thefollow-up time intervals the salivary flow rate did not differ significantlybetween the two groups. However, Group I showed an increased salivary flow ratein the follow-up time intervals and sustained the effect till the end of ourstudy.

There were significant reductionsin salivary levels of mutans streptococci at 30 days after intervention whencompared to the baseline and the effect was maintained even beyondinterruption. Group I showed greater amounts of mutans streptococcus countsreduction at the end of follow-up phase when compared to Group II.

Thus our study supports theaction of 100% xylitol chewing gums at the dose and frequency used in our studyin reduction of mutans streptococci and this strategy can be used as a targetedcaries-preventive measure after the evaluation of its cost-effectivenessthrough various preventive programs.

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 Investigator Blinded

入排标准

年龄范围
18.00 Year(s) 至 20.00 Year(s)(—)
性别
All

入选标准

  • Subjects who did not have any active carious lesions.
  • Subjects who were not on any systemic antibiotic medication, 3 months prior to the commencing of the study.

排除标准

  • Subjects who had recent exposure to topical or systemic fluoride treatment.
  • Subjects who were phenylketonurics.
  • Subjects who had a history gastro-intestinal problems.
  • Subjects who were habitual consumer of chewing gums.
  • Subjects who were undergoing any orthodontic treatment at the time of the study.

结局指标

主要结局

the action of 100% xylitol chewing gums at the dose and frequency used in our study in reduction of mutans streptococci and this strategy can be used as a targeted caries-preventive measure

时间窗: 30, 60 , 90 days

次要结局

  • Follow-up for measuring stretptococcus mutans count, salivary pH levels and buffering capacity(60 days and 90 days)

研究者

发起方
The Oxford Dental College and Hospital
申办方类型
Research institution and hospital

研究点 (1)

Loading locations...

相似试验