Impact of Maternal Xylitol Consumption on Mutans Sterptococci

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

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries and Streptococcus Mutans Count
• Intervention / Treatment: Drug: xylitol; Drug: fluoride varnish application

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Saudi Arabia
  • P.O Box 80209
    • Jeddah, P.O Box 80209, Saudi Arabia, 21589
      • King abulaziz University, Dental University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 months to 3 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Drug: 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; Other Names: Fennobon Oy, Yrittäjäntie, Finneland - chewing; gum, tablet , 1.8g and containing 66% xylitol by weight,
ACTIVE_COMPARATOR: 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.	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.; Other Names: fluoride varnish (Duraphat 5% Na F ,Ultradent Products, Utah, USA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assesment of mutans streptococci count in off-spring	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.	24 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assesment of Caries level in off-spring	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. .	24 month

Collaborators and Investigators

• Sponsor: King Abdulaziz University

Publications and helpful links

General Publications

• Alamoudi NM, Hanno AG, Sabbagh HJ, Masoud MI, Almushayt AS, El Derwi DA. Impact of maternal xylitol consumption on mutans streptococci, plaque and caries levels in children. J Clin Pediatr Dent. 2012 Winter;37(2):163-6. doi: 10.17796/jcpd.37.2.261782tq73k4414x.

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (ACTUAL): July 1, 2011
• Study Completion (ACTUAL): September 1, 2011

Study Registration Dates

• First Submitted: December 31, 2013
• First Submitted That Met QC Criteria: January 12, 2014
• First Posted (ESTIMATE): January 14, 2014

Study Record Updates

• Last Update Posted (ESTIMATE): January 14, 2014
• Last Update Submitted That Met QC Criteria: January 12, 2014
• Last Verified: January 1, 2014

More Information

Terms related to this study

• Keywords: children; prevention; caries; plaque; Xylitol; Mutans streptococci
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides; Fluorides, Topical
• Other Study ID Numbers: KAU