The first question that needs to be addressed is to clarify what the distribution and interrelation is of relevant clinical microbial, biochemical and immunological parameters of the oral ecosystem in a systemically healthy (non diseased) young…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
gezonde mond, tandvleesontsteking
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primaire study parameter is the level of gingival inflammation (Bleeding On
Marginal Probing (BOMP) and Bleeding upon Pocket Probing (BPP)).
Secondary outcome
In total there are 20 secondairy study parameters:
1. Subjective oral health
2. Generic health-related quality of life
3. Oral health-related quality of life
4. General level of nutrition measured by the Validated Food Frequency
questionnaire:
a. Frequency of food intake
b. Macronutrients
c. Micronutrients
d. Sugar intake
e. Soft drinks
f. Energy drinks
g. Juices
5. Systolic and diastolic blood pressure
6. Pulse
7. Body temperature
8. Body Mass Index
a. Standing height
b. Body weight
9. Abdominal (Waist) circumference
10. Blood cell parameters
a. White blood cells
b. Red blood cells
11. Blood biochemical parameters
a. Cholesterol level in blood
b. Glucose level in blood
12. Oral PMN numbers and function in comparison with systemic PMN
a. Count number PMN: in saliva and in blood
b. Determine functionality of PMN: from saliva and from blood
13. Saliva
a. Flow rate
b. pH measurement saliva
c. Salivary proteome
d. Microbiological composition
e. Metabolite analyses
14. Plaque samples
a. Metabolic activity of the dental plaque from the vestibular aspect of the
upper jaw
b. Microbial and micobial composition of dental plaque from the lingual aspect
of the lower jaw
c. Microbial and micobial composition of the interproximal plaque
d. Microbial and micobial composition of the subgingival plaque.
e. Metagenomic profiles of plaque samples
15. Microbial and micobial ecology tongue dorsum
a. Anterior part of dorsum tongue
b. Posterior part of dorsum tongue
16. Level of calculus formation at lower front teeth
a. Calculus Volpe-Manhold index
17. Level of dental plaque
a. Modified Silness & Löe plaque index
18. Dental caries experience
a. Decayed, missed, filled teeth (DMFS)
b. International Caries Assessment and Detection System (ICDAS)
c. Dentinal occlusal and approximal caries
19. Oral malodour
a. Organoleptic score
20. Volatile Sulphur Compounds (VSC*s)
a. OralChroma outcome
b. Halimeter outcome
21. Extent of tongue coating
a. Discoloration
b. Thickness
c. Tongue body structure and shape
Background summary
Maintaining a healthy oral environment is essential for many oral functions,
including e.g. chewing, tasting, social interactions and speech (Locker, 2004).
Most of our knowledge concerning oral physiology is primarily based on disease
parameters (progression/treatment /maintenance) and not as much on parameters
of oral health.
This research project will embark on a new approach where focus is given to
understanding an defining, the healthy status of the oral cavity. The project
aims to identify the biological processes in the oral ecosystem responsible for
maintaining oral health. An important part of the project, described in this
protocol is the evaluation of the biochemical, immunological, metabolic and
microbial inter-individual diversity in relation to early indicators for oral
disease, including dental plaque and gingival bleeding. Such database will
provide suggestions on biological interactions between the host, and the
microbiota colonizing the various niches in the oral cavity as well as a
possible role in the onset of dental plaque formation as well as inflammatory
processes.
Detailed insight in these processes have the potential for the development of
novel diagnostic tools to evaluate oral health status of an individual by oral
care professionals, and relating these insights to procedures for treatment and
instructions for self care.
The questions is: how can we define a healthy oral cavity in particular on
parameters?
Study objective
The first question that needs to be addressed is to clarify what the
distribution and interrelation is of relevant clinical microbial, biochemical
and immunological parameters of the oral ecosystem in a systemically healthy
(non diseased) young adult population.
This will be achieved through the creation of an integrated dataset of 250
volunteers. Such biodata provide a framework for the interpretation of
deflection in the ecosystem as early indicators for changes in health status.
Study design
This study is a cross-sectional, single-center single evaluation of various
health related clinical, salivary, serological and microbiological parameters
of 250 healthy young adult individuals without periodontitis. After the
subjects are screened for suitability they visit the clinic twice on the same
day. Clinical measurements are performed in the morning and in the afternoon.
Study burden and risks
Pain, bleed, and the formation of a hematoma ar the main said effects of blood
collection.
Gustav Mahlerlaan 3004
Amsterdam 1081 LA
NL
Gustav Mahlerlaan 3004
Amsterdam 1081 LA
NL
Listed location countries
Age
Inclusion criteria
- Young individuals, * 18 years - 30 year
- Male and female
- Classified as systemically healthy, assessed by medical questionnaire
- Minimum of 20 natural teeth: all first molars and second and/or third molars in the upper jaw available
- Agree to present without eating and drinking on the morning of the appointment
- Having visited the dentist for a regular check-up within the last year necessary treatment included
- Willing and able to give written informed consent
- Willing to consent to use the collected body materials anonymous and coded
- Willing to refrain from brushing 24 hours before the morning appointment.
Exclusion criteria
- Anyone presenting a probing depth * 5mm with bleeding on probing and attachment loss * 2 mm, Dutch Periodontal Screening Index score 3+/ 4
- Overt dental caries
- No interproximal restorations between the first and second or third and second upper molars
- Smokers, definition smoker: * 1 cigarette every day
- Removable partial dentures
- Removable night guard
- Oral and/or peri-oral piercings
- Ongoing dental treatment or any other medical treatment of the oral cavity
- Presence of orthodontic banding (except for lingual retention wire)
- Abuse of drugs/ alcohol
- Dental student or dental professional
- Participation in a clinical study within the previous 30 days
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 | NL41094.018.12 |