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The effect of maltitol and xylitol sweetened chewing gum on caries risk factors of dental plaque and saliva, and on the development of gingivitis in a 21 day non-brushing study model

Completed
Conditions
mondgezondheid
caries
cavities and gum disease
Registration Number
NL-OMON36248
Lead Sponsor
Roquette Freres
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
220
Inclusion Criteria

- Male and female between18 and 30 years
- Self classified as healthy
- At least 5 evaluable teeth in each quadrant
- With moderate gingivitis (30-60% bleeding on marginal probing)
- Non-smokers

Exclusion Criteria

- Any known allergy to any of the ingredients (xylitol or maltitol) of the study products
- Current periodontitis with periodontal pocketing over 5mm
- Any pathological change of the oral mucosa
- Wearing of an (intra-)oral piercing
- Use of antibiotics in 30 days prior to the experiment
- Participation in professional dental cleaning during the study period
- Abuse of drugs, alcohol, etc.
- Systemic disease such as diabetes or HIV
- Pregnancy or breastfeeding
- Participation in a clinical study within the previous 30 days
- Orthodontic appliances and banding
- Removable prosthesis
- Usually consumer of more than 3 sugar-free chewing gums a day

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The effect of chewing gum sweetened with various polyols in a 21-days non<br /><br>brushing model on the pH and the amount of dental plaque, and on selected oral<br /><br>pathogens in dental plaque, being:<br /><br>Total bacterial numbers<br /><br>Streptococcus sanguinis<br /><br>Streptococcus mutans<br /><br>Actinomyces naeslundii<br /><br>Lactobacillus casei<br /><br>Veillonella dispar<br /><br>Fusobacterium nucleatum.<br /><br>Prevotella intermedia<br /><br>Porphyromonas gingivalis<br /><br>Aggregatibacter actinomycetencomitans</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>The effect of chewing gum sweetened with various polyols in a 21-days non<br /><br>brushing model on various markers of oral health in dental plaque and saliva<br /><br>being gingivitis, salivary flow rate, salivary pH, sucrase activity, sialidase<br /><br>activity, acid production upon sucrose challenge and insoluble glucan.</p><br>
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