Impact of Maternal Xylitol Consumption on Mutans Sterptococci

NCT02036151 | Completed Phase 4 DMC

• 1 other identifier: KAU
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries and Streptococcus Mutans Count

Keywords

Xylitol; prevention; Mutans streptococci; caries; plaque; children

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Assesment of Caries level in off-spring

  24 month

Study Arms (2)

Experimental, control

EXPERIMENTAL

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

fluoride varnish application

ACTIVE COMPARATOR

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

Interventions

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

Also known as: Fennobon Oy, Yrittäjäntie, Finneland - chewing, gum, tablet , 1.8g and containing 66% xylitol by weight,

Experimental, control

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.

Also known as: fluoride varnish (Duraphat 5% Na F ,Ultradent Products, Utah, USA)

fluoride varnish application

Eligibility Criteria

• Age: 10 Months - 36 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• subjects with systemic disorders or on regular medications

Sponsors & Collaborators

• King Abdulaziz University: lead

Study Sites (1)

King abulaziz University, Dental University Hospital

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

Location

Related Publications (1)

• 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.

  PMID: 23534323 RESULT

MeSH Terms

Conditions

Dental Caries; Plaque, Amyloid

Interventions

Xylitol; Chewing Gum; Tablets; sodium fluoride topical preparation

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates; Plant Gums; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Plant Exudates; Biological Products; Complex Mixtures; Candy; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages; Dosage Forms; Pharmaceutical Preparations

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Chairman Preventive Dental Sciences

Study Record Dates

• First Submitted: December 31, 2013
• First Posted: January 14, 2014
• Study Start: February 1, 2009
• Primary Completion: July 1, 2011
• Study Completion: September 1, 2011
• Last Updated: January 14, 2014

Record last verified: 2014-01

Locations

SA (1)