The main objective of this study is to compare the effect of chewing gum sweetened with maltitol or xylitol to the use of gum base on (the development of) gingivitis and on some plaque and salivary caries risk factors.
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
mondgezondheid
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
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 outcome
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.
Background summary
Saliva has many properties to promote oral health. It clears off food remnants
and cleans (washes) the mouth resulting in a reduced time that oral health is
at risk after the intake of food. Furthermore saliva contains natural
antimicrobials which will reduce the growth of dental plaque. The use of
chewing gum stimulates the salivary flow. An active antimicrobial role of sugar
substitutes is claimed. Xyltiol chewing gum is acknowledged by EFSA: *Chewing
gum sweetened with 100% xylitol has been shown to reduce dental plaque. High
content/level of dental plaque is a risk factor in the development of caries in
children.* There are, however, important questions that remain to be
answered: 1. is this claim specific for xylitol or may also other sugar
substitutes exert these effects, 2. does the reduction of dental plaque also
result in a more healthy gingiva (less gingivitis) and 3. Is the reduction of
dental plaque generic or are with diseased associated species more affected
than others. The first question is important because it would increase the
number of (*functional*) foods available to the public. The second question is
important, while gingivitis is a prevalent oral disorder. The third answer will
give us more insight in the mechanisms involved.
Study objective
The main objective of this study is to compare the effect of chewing gum
sweetened with maltitol or xylitol to the use of gum base on (the development
of) gingivitis and on some plaque and salivary caries risk factors.
Study design
The design of the study is a four group double-blind placebo controlled
intervention study lasting for 3 weeks. Within each group a split mouth design
will be used, participants will not to brush the teeth in the lower jaw for 3
weeks while maintaining normal oral hygiene in the upper jaw.
Intervention
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 use 2 pieces of gum 5 times a day for 10 minutes after
breakfast, lunch, snack in the afternoon or in the middle of the afternoon,
after diner and before sleeping
There is a 21-days non brushing model in which the participants do not brush
the lower jaw for 3 weeks.
Study burden and risks
none
62136 Lestrem
62136 Lestrem
FR
62136 Lestrem
62136 Lestrem
FR
Listed location countries
Age
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL35214.029.11 |