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Trial record 94 of 292 for:    Sodium Fluoride OR Duraphat

Impact of Maternal Xylitol Consumption on Mutans Sterptococci

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ClinicalTrials.gov Identifier: NCT02036151
Recruitment Status : Completed
First Posted : January 14, 2014
Last Update Posted : January 14, 2014
Sponsor:
Information provided by (Responsible Party):
Najlaa Alamoudi, King Abdulaziz University

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.

Condition or disease Intervention/treatment Phase
Dental Caries and Streptococcus Mutans Count Drug: xylitol Drug: fluoride varnish application Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Impact of Maternal Xylitol Consumption on Mutans Sterptococci ,Plaque and Caries Levels in Children
Study Start Date : February 2009
Actual Primary Completion Date : July 2011
Actual Study Completion Date : September 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tooth Decay

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




Primary Outcome Measures :
  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 Outcome Measures :
  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.

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Ages Eligible for Study:   10 Months to 36 Months   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02036151


Locations
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Saudi Arabia
King abulaziz University, Dental University Hospital
Jeddah, P.O Box 80209, Saudi Arabia, 21589
Sponsors and Collaborators
King Abdulaziz University

Publications of Results:
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Responsible Party: Najlaa Alamoudi, Prof. Chairman Preventive Dental Sciences, King Abdulaziz University
ClinicalTrials.gov Identifier: NCT02036151     History of Changes
Other Study ID Numbers: KAU
First Posted: January 14, 2014    Key Record Dates
Last Update Posted: January 14, 2014
Last Verified: January 2014
Keywords provided by Najlaa Alamoudi, King Abdulaziz University:
Xylitol
prevention
Mutans streptococci
caries
plaque
children
Additional relevant MeSH terms:
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Listerine
Fluorides
Fluorides, Topical
Sodium fluoride topical preparation
Sodium Fluoride
Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents