Main objective is to investigate if low molecular weight fraction of edible mushroom Shiitake extract possesses clinically relevant caries preventive properties
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
caries preventie
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Amount of organic acids in plaque and microbial composition of plaque before
and after each test period
Secondary outcome
Amount of dental plaque before and after each test period
Background summary
The proposed randomized controlled trial is a part of the Specific Targeted
Research or Innovation Project (STRIP) granted by EU sixth framework program,
under thematic priority *Food Quality and Safety*, entitled: "Towards
functional foods for oral health care - isolation, identification and
evaluation of beverage and food components with anti-caries and/or
anti-gingivitis activities" (EU contract FOOD-CT-2006-36210, project acronym
"NUTRIDENT*, start of the project 01-10-2006). In vitro results obtained within
this project indicate that low molecular weight fraction of edible mushroom
Shiitake extract may have an anti-gingivitis and caries-preventive potential.
The outcome of the proposed clinical study is of major importance in further
development of oral care product(s) that would have beneficial effects on oral
health.
Study objective
Main objective is to investigate if low molecular weight fraction of edible
mushroom Shiitake extract possesses clinically relevant caries preventive
properties
Study design
Double-blind, three-leg cross-over randomized controlled clinical trial
Intervention
All volunteers will rinse their mouth twice-daily in a randomised order with 1)
a mouthwash containing low molecular weight fraction of edible mushroom
Shiitake extract, 2) a placebo mouthwash or 3) a positive control Meridol®
(GABA Int, Switzerland) mouthwash, for two weeks, with a 2-week washout period
in between each rinsing period.
Study burden and risks
Burden: Study subjects will have to visit ACTA eight times for 20 min during a
period of 13 weeks and will have to abstain from toothbrushing for 48 h and
from any food and dring intake for 2 h before each visit.
Risks: There are no risks associated with participation to the study.
Benefit: Study participants are expected to benefit from professional oral
hygiene procedure that will be carried out at the start of the study.
Group relatedness: Two-week long washout periods have been shown to be
sufficiently long to eliminate carry-over effect of Meridol (Gerardu et al.,
2006).
Louwesweg 1
1066EA Amsterdam
Nederland
Louwesweg 1
1066EA Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
Healthy males and females that would:
* Be 18 years of age or older
* Be in good general health as determined by the investigator based on a review of the medical history/update
* Possess at least three posterior teeth (premolars/molars) in each quadrant (with no partial dentures, orthodontic banding or wires)
Exclusion criteria
* Have not passed all inclusion criteria
* Have used antibiotics less than three months prior the start of the study
* Have untreated caries or periodontal disease
* Have reduced stimulated salivary flow (< 0.7 ml/min)
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 | NL21480.029.08 |