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

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 - Maltitol and oral health

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON36248

Enrollment

220

Registered

2011-08-25

Start date

2011-09-13

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

mondgezondheid caries cavities and gum disease

Interventions

There are four treatments: 1. chewing gum base containing maltitol 2. chewing gum base containing xylitol 3. positive control: chewing gum base 4. negative control: no gum group The participants will

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
The effect of chewing gum sweetened with various polyols in a 21-days non brushing model on the pH and the amount of dental plaque, and on selected oral pathogens in dental plaque, being: Total bacterial numbers Streptococcus sanguinis Streptococcus mutans Actinomyces naeslundii Lactobacillus casei Veillonella dispar Fusobacterium nucleatum. Prevotella intermedia Porphyromonas gingivalis Aggregatibacter actinomycetencomitans	—

Measure

Time frame

The effect of chewing gum sweetened with various polyols in a 21-days non brushing model on the pH and the amount of dental plaque, and on selected oral pathogens in dental plaque, being: Total bacterial numbers Streptococcus sanguinis Streptococcus mutans Actinomyces naeslundii Lactobacillus casei Veillonella dispar Fusobacterium nucleatum. Prevotella intermedia Porphyromonas gingivalis Aggregatibacter actinomycetencomitans

—

Secondary

Measure	Time frame
The effect of chewing gum sweetened with various polyols in a 21-days non brushing model on various markers of oral health in dental plaque and saliva being gingivitis, salivary flow rate, salivary pH, sucrase activity, sialidase activity, acid production upon sucrose challenge and insoluble glucan.	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)