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van CCT (UK)

van CCT (UK)

What are the boundaries of a healthy mouth?

- candidate number13408
- NTR NumberNTR3649
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR4-okt-2012
- Secondary IDs2012_210 / NL41094.018.12; METC / CCMO
- Public TitleWhat are the boundaries of a healthy mouth?
- Scientific TitleEstimating the boundaries for a healthy oral ecosystem in young individuals: An observational clinical study.
- hypothesisThe objectives 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. Such biodata provide a framework for the interpretation of deflection in the ecosystem as early indicators for changes in health status.
- Healt Condition(s) or Problem(s) studiedHealthy subjects
- Inclusion criteria1. Young individuals ≥ 18 years and ≤ 30 year;
2. Male and female;
3. Classified as systemically healthy, assessed by medical questionnaire;
4. Minimum of 20 natural teeth: All first molars and second and/or third molars in the upper jaw available;
5. Agree to present with overnight plaque;
6. Agree to present without eating and drinking on the morning of the appointment;
7. Having visited the dentist for a regular check-up within the last year necessary treatment included;
8. Willing and able to give written informed consent;
9. Willing to consent to use the collected body materials anonymous and coded.
- Exclusion criteria1. Anyone presenting a probing depth ≥ 5mm with bleeding on probing and attachment loss ≥ 2 mm;
2. Dutch Periodontal Screening Index score 3+/ 4-;
3. Overt dental caries;
4. No interproximal restorations between the first and second or third and second upper molars;
5. Smokers, definition smoker: ≥ 1 cigarette every day;
6. Removable partial dentures;
7. Removable night guard;
8. Oral and/or peri-oral piercings;
9. Ongoing dental treatment or any other medical treatment of the oral cavity;
10. Presence of orthodontic banding (except for lingual retention wire);
11. Abuse of drugs/ alcohol;
12. Dental student or dental professional;
13. Participation in a clinical study within the previous 30 days.
- mec approval receivedyes
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeobservational
- planned startdate 9-okt-2012
- planned closingdate4-okt-2013
- Target number of participants250
- InterventionsN/A
- Primary outcome1. Bleeding On Marginal Probing (BOMP);
2. Bleeding upon Pocket Probing (BPP).
- Secondary outcome1. 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 PMNL
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
- Timepoints1. Visit 1: Screening;
2. One day;
3. Visit 2: Early morning;
Visit 3: Afterrnoom.
- Trial web siteN/A
- statusopen: patient inclusion
- CONTACT for SCIENTIFIC QUERIESDr. G.A. Weijden, van der
- Sponsor/Initiator TI Food & Nutrition
- Funding
(Source(s) of Monetary or Material Support)
GlaxoSmithKline, TNO, Wageningen University, Wrigley en Cargill
- PublicationsN/A
- Brief summaryMaintaining 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.
- Main changes (audit trail)
- RECORD4-okt-2012 - 20-okt-2012

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