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Completed

NCT Number: NCT02036151

Impact of Maternal Xylitol Consumption on Mutans Sterptococci

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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Key information

Conditions

Dental Caries and Streptococcus Mutans Count Dental Caries Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Plaque, Amyloid Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

10 month–36 month

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

King abulaziz University, Dental University Hospital

Jeddah, P.O Box 80209, 21589, Saudi Arabia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • subjects with systemic disorders or on regular medications

Treatment and study plan

Xylitol

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

Other names: Fennobon Oy, Yrittäjäntie, Finneland - chewing, gum, tablet , 1.8g and containing 66% xylitol by weight,

fluoride varnish application

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.

Other names: fluoride varnish (Duraphat 5% Na F ,Ultradent Products, Utah, USA)

Primary outcomes

  1. Assesment of mutans streptococci count in off-spring

    Time frame: 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.

Secondary outcomes

  1. Assesment of Caries level in off-spring

    Time frame: 24 month

    Clinical examination was carried out for dmft score for deciduous teeth after 6, 12, 18 and 24 months from the initiation maternal xylitol consumption. The diagnosis of dental caries was based on the WHO criteria 1987.

    .

Sponsors and collaborators

Lead sponsor

King Abdulaziz University

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jan 14, 2014
Registry last updated
Jan 14, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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