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临床试验/NCT02036151
NCT02036151已完成4 期

Impact of Maternal Xylitol Consumption on Mutans Sterptococci ,Plaque and Caries Levels in Children

King Abdulaziz University1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2009年2月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
60
试验地点
1
主要终点
Assesment of mutans streptococci count in off-spring

研究概览

简要总结

The study was designed to determine whether maternal xylitol consumption through regular chewing of xylitol gums can affect the salivary mutans streptococci (MS), dental caries, and dental plaque levels of their children.

详细描述

Method: Study sample included 60 mother and child pairs with high salivary mutans streptococcus (MS) levels. Samples were randomly divided into experimental group (30 pairs) and control group (30 pairs). Mothers in the experimental group received xylitol chewing gum treatment three times/day for three months, whereas the controls received fluoride varnish. Both groups received oral hygiene instructions, dietary counseling and restorative treatment. All children were examined after 6, 12 and 18 months from the initiation of the study to assess caries, plaque and salivary mutans streptococcus (MS) levels.

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 (Outcomes Assessor)

入排标准

年龄范围
10 Months 至 36 Months(Child)
性别
All
接受健康志愿者

入选标准

  • mothers with high salivary counts (≥ 105)
  • mothers having children at least 10 months of age (10-36months) or having a minimal of 8 primary teeth.

排除标准

  • subjects with systemic disorders or on regular medications

研究组 & 干预措施

Experimental, control

Experimental

Mothers in the experimental group were instructed to chew 1 pellet of xylitol gum (Fennobon Oy, Yrittäjäntie, Finneland -gum, 3 times ) for a period of 3 months. control mothers did not receive any medications. All mothers received oral hygiene instructions and restorative treatment when needed. Offspring of both the experimental and control groups did not receive any medication and were followed for at 6,12, 18 and 24 month from initiation of mothers consumption. month

干预措施: xylitol (Drug)

fluoride varnish application

Active Comparator

The control group participated in a preventive program under the supervision of the Pediatric Dentistry Department. The program activities consisted of oral hygiene instructions, fluoride varnish application (Duraphat 5% Na F ,Ultradent Products, Utah, USA) and restorative treatment when needed.

干预措施: fluoride varnish application (Drug)

结局指标

主要结局

Assesment of mutans streptococci count in off-spring

时间窗: 24 month

Collection of saliva samples was carried out for microbiological screening after 6, 12, 18 and 24 months from the initiation xylitol consumption .Un stimulated saliva samples were collected from each child for salivary bacterial level screening. Saliva sampling was performed before conducting the clinical examination between 9-11 am. Children were not allowed to eat or drink for 2 hours before sampling. Saliva was collected with the pipette supplied by the dentocult (CRT) kit. (Ivoclar Vivadent, Lichtenstein). Saliva sample was not taken if the child has received antibiotics within 1 month prior the examination. Screening of stimulated saliva samples for mutans streptococcus (MS) level were carried out using the dentocult method (CRT). Findings of 105 CFU or more of MS indicates a high caries risk, whereas findings less than 105 CFU is considered low caries risk.

次要结局

  • Assesment of Caries level in off-spring(24 month)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Najlaa Alamoudi

Prof. Chairman Preventive Dental Sciences

King Abdulaziz University

研究点 (1)

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