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Impact of Maternal Xylitol Consumption on Mutans Sterptococci

Primary Purpose

Dental Caries and Streptococcus Mutans Count

Status
Completed
Phase
Phase 4
Locations
Saudi Arabia
Study Type
Interventional
Intervention
xylitol
fluoride varnish application
Sponsored by
King Abdulaziz University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Dental Caries and Streptococcus Mutans Count focused on measuring Xylitol, prevention, Mutans streptococci, caries, plaque, children

Eligibility Criteria

10 Months - 36 Months (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • King abulaziz University, Dental University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental, control

fluoride varnish application

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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. .

Full Information

First Posted
December 31, 2013
Last Updated
January 12, 2014
Sponsor
King Abdulaziz University
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1. Study Identification

Unique Protocol Identification Number
NCT02036151
Brief Title
Impact of Maternal Xylitol Consumption on Mutans Sterptococci
Official Title
Impact of Maternal Xylitol Consumption on Mutans Sterptococci ,Plaque and Caries Levels in Children
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
King Abdulaziz University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries and Streptococcus Mutans Count
Keywords
Xylitol, prevention, Mutans streptococci, caries, plaque, children

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental, control
Arm Type
Experimental
Arm Description
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
Arm Title
fluoride varnish application
Arm Type
Active Comparator
Arm Description
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
Intervention Name(s)
xylitol
Other Intervention Name(s)
Fennobon Oy, Yrittäjäntie, Finneland - chewing, gum, tablet , 1.8g and containing 66% xylitol by weight,
Intervention Description
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
Intervention Name(s)
fluoride varnish application
Other Intervention Name(s)
fluoride varnish (Duraphat 5% Na F ,Ultradent Products, Utah, USA)
Intervention Description
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.
Primary Outcome Measure Information:
Title
Assesment of mutans streptococci count in off-spring
Description
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.
Time Frame
24 month
Secondary Outcome Measure Information:
Title
Assesment of Caries level in off-spring
Description
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. .
Time Frame
24 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
10 Months
Maximum Age & Unit of Time
36 Months
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
King abulaziz University, Dental University Hospital
City
Jeddah
State/Province
P.O Box 80209
ZIP/Postal Code
21589
Country
Saudi Arabia

12. IPD Sharing Statement

Citations:
PubMed Identifier
23534323
Citation
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.
Results Reference
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Impact of Maternal Xylitol Consumption on Mutans Sterptococci

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