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What are the boundaries of a healthy mouth?

Estimating the boundaries for a healthy oral ecosystem in young individuals: An observational clinical study.

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON29418
Enrollment
250
Registered
2012-10-04
Start date
2012-10-09
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

- Goverment funding source (one third part) - Second funding source (one third part) Top Institute Food & Nutrition (TIFN) Wageningen - Industry (one third part)
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. 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 criteria

Exclusion criteria: 1. 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.

Design outcomes

Primary

MeasureTime frame
1. Bleeding On Marginal Probing (BOMP); 2. Bleeding upon Pocket Probing (BPP).

Secondary

MeasureTime frame
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 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. Discolorati

Contacts

Public ContactG.A. Weijden, van der

Acedemisch Centrum Tandheelkunde Amsterdam (ACTA) Afdeling CPT- Parodontologie Gustav Mahlerlaan 3004

ga.vd.weijden@acta.nl+31 (0)20 5188307

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)