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van CCT (UK)

van CCT (UK)

Dynamic oral ecosystem

- candidate number20810
- NTR NumberNTR4863
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR27-okt-2014
- Secondary IDsTIFNOH-001-WP2  
- Public TitleDynamic oral ecosystem
- Scientific TitleAn exploratory study on the dynamic (microbial, biochemical and immunological) interactions of the oral ecosystem during induction of mild gingival inflammation
- hypothesisWe hypothesize this difference is due to differences in the mechanisms by which the individuals can withstand and/or adapt to the stress conditions applied in the clinical model and that these mechanisms are of key importance in our ability to maintain our oral health. We expect that – in analogy of other biological systems – the mouth has intrinsic mechanisms to maintain or restore homeostasis following a perturbance. These processes have up to date gained little attention in research. By examining in detail the dynamic biological responses of the oral ecosystem in individuals during experimental gingivitis induction and relating these responses to individual variation in the inflammatory outcome, it is expected that the biological processes that contribute to our ability to maintain oral health can be identified.
- Healt Condition(s) or Problem(s) studiedGum tissue, Gingival health
- Inclusion criteria• Adult, ≥ 18 years - 55 year
• Male and female
• Classified as systemically healthy, assessed by medical questionnaire
• Minimum of 20 natural teeth: first and second molars must be present
• Having visited the dentist for a regular check-up within the last year and having finished the necessary treatment.
• Willing and able to give written informed consent
• Willing to consent to use their collected anonymous and coded body materials for further research
- Exclusion criteria• Anyone presenting with a dental pocket probing depth ≥ 5mm with bleeding on probing and attachment loss ≥ 2 mm, Dutch Periodontal Screening Index score 3+/ 4
• >40% BOP
• Overt dental caries
• Smokers, definition non-smoker: <1 cigarette every day for at least one year
• Removable partial dentures
• Removable night guard
• Oral and/or peri-oral piercings
• Apparent oral lesions (aphthous ulcers excluded)
• Presence of orthodontic banding (except for lingual retention wire)
• Abuse of drugs/alcohol
• ACTA dental student or ACTA professional
• Participation in a clinical study within the previous 30 days

General health and use of medication:
• Self-reported pregnancy or breastfeeding
• Use of antibiotics during the last 3 months
• Need of antibiotic prophylaxis prior to dental treatment
• Use of anti-inflammatory drugs on a regular basis
• Evidence of any systemic disease or compromised health condition
• Acute sinusitis
• Severe oral- pharyngeal infections
• Current disorders/disease resulting in (self-induced) vomiting
• Reduced salivary flow due to pathological reasons (e.g. Sjφgren syndrome)
• Adverse medical history or long-term medication
• Prescribed medication (except for contraceptives - birthcontrol pills)
- mec approval receivedno
- multicenter trialno
- randomisedno
- groupParallel
- TypeSingle arm
- Studytypeintervention
- planned startdate 12-jan-2015
- planned closingdate31-jul-2015
- Target number of participants80
- InterventionsChallenge intervention: no oral hygiene for 2 weeks
Intervention: erythritol tablets
- Primary outcomeMicrobiological composition
- Secondary outcomeBiochemical, immunological and clinical effects
- TimepointsDay -14, 0, 2, 5, 9, 14, 21
- Trial web site
- statusplanned
- CONTACT for SCIENTIFIC QUERIESProf. dr. W. Crielaard
- Sponsor/Initiator Academic Center Dentistry Amsterdam (ACTA)
- Funding
(Source(s) of Monetary or Material Support)
Academic Center Dentistry Amsterdam (ACTA)
- Publications
- Brief summary
- Main changes (audit trail)
- RECORD27-okt-2014 - 22-nov-2014

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