Impact of Maternal Xylitol Consumption on Mutans Sterptococci

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Dental Caries and Streptococcus Mutans Count

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Experimental, control

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

Group Type EXPERIMENTAL

xylitol

Intervention Type DRUG

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

fluoride varnish application

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.

Group Type ACTIVE_COMPARATOR

fluoride varnish application

Intervention Type DRUG

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.

Interventions

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xylitol

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

Intervention Type DRUG

fluoride varnish application

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.

Intervention Type DRUG

Other Intervention Names

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Fennobon Oy, Yrittäjäntie, Finneland - chewing gum, tablet , 1.8g and containing 66% xylitol by weight, fluoride varnish (Duraphat 5% Na F ,Ultradent Products, Utah, USA)