We want to investigate the hypothesis that daily use of the above mentioned supplements (consisted of concentrated fruit en vegetables) results in improved healing of periodontal tissues in patients suffering from periodontitis. Besides we…
ID
Source
Brief title
Condition
- Other condition
- Bacterial infectious disorders
Synonym
Health condition
parodontitis
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Clinical parameters of the periodontal condition: Modifief gingival index
(MGI), Marginal bleeding on probing, Probing Pocket depth (PPD),
quality-of-life assessment.
Secondary outcome
Other clinical parameters: % bleeding sites, recession, attachment level,
plaque scores.
Biochemical parameters: levels of vit. C and beta carotene, hsCRP, number of
leukocytes, glucose, insulin, fibrinogen, HbA1c, cholesterol, triglycerides
Background summary
Approximately 10% of the Dutch population is susceptible to developing severe
periodontitis. This disease, if untreated, will cause inevitably loss of
alveolar bone and finally loss of teeth.
The individual susceptibility to periodontitis is determined by a number of
factors amongst others genetic predisposition, smoking and stress. In the light
of new research data it seems that nutrition could as well be related to this
susceptibility. In particular, it seemed that the levels of certain vitamins in
the blood are lower in periodontitis patients that their healthy counterparts.
A company produces food supplements regulated by FDA (Food and Drug
Administration, USA) and rules dictated by the European Union. The
concentrate(Juice Plus+®) is used for 15 years without any reported
side-effects.
The question is whether daily use of these foof supplements will reduce the
severity of periodontitis (3 months observational period) and whether the
result of the periodontal treatment will be better in periodontitis patients
that use these supplements.
Study objective
We want to investigate the hypothesis that daily use of the above mentioned
supplements (consisted of concentrated fruit en vegetables) results in improved
healing of periodontal tissues in patients suffering from periodontitis.
Besides we investigate " patient centered outcomes" by means of a
quality-of-life questionnaire. This investigation is performed in a
multi-center design where ACTA is one of the centers.
Study design
parallel randomized double blind placebo control
Intervention
17 patients will receive the test product: twice daily 3 capsules (Juice
Plus+®)
The other 17 patients will receive a placebo.
Study burden and risks
Inconvenience and risks for the participants:
* Preliminary selection: telephonic interview (10 min)
* 1st appointment (60 min): medical and dental anamneses, quality of life
assessment questionnaire, clinical and laboratory parameters
* Short telephonic conversation after 2 weeks (5 min)
* 2nd appointments after 6 weeks: inspection oral cavity, short conversation
(15 min)
* 3rd appointment after 3 months (60 min): quality of life assessment,
clinical and laboratory parameters
* Treatment by Staff (3-4 appointments depending on the situation)
* 4th appointment (60 min): quality of life assessment questionnaire, clinical
and laboratory parameters
* No risks, except for minor discomfort after blood taking (small hematoma) and
some slight stomach discomfort, this is the reason we advise to take the
products with full stomach.
Louwesweg 1
1066EA
NL
Louwesweg 1
1066EA
NL
Listed location countries
Age
Inclusion criteria
* be aged 18 and over;
* have a minimum of 20 teeth,
* have chronic periodontitis
* be capable of giving informed consent themselves.
Exclusion criteria
* less than 20 teeth
* pregnancy or breast feading
* complexe medical background
* long-term use of antibacterial- or anti-inflammatory medication
* unable to use the capsules the way they are prescribed
* regular use of vitamin supplements
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 | NL32599.018.10 |