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Dynamic oral ecosystem

An exploratory study on the dynamic (microbial, biochemical and immunological) interactions of the oral ecosystem during induction of mild gingival inflammation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON20662
Enrollment
80
Registered
2014-10-27
Start date
2015-01-12
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

Gingival inflammation

Interventions

Challenge intervention: no oral hygiene for 2 weeks Intervention: erythritol tablets

Sponsors

Prof. dr. J.R. Bausch ACTA Dental Research B.V. (ADR) Gustav Mahlerlaan 3004 1081 LA Amsterdam The Netherlands r.bausch@acta.nl
Lead Sponsor

Eligibility

Inclusion criteria

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

Exclusion criteria: • Anyone presenting with a dental pocket probing depth &#8805; 5mm with bleeding on probing and attachment loss &#8805; 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. Sjögren syndrome) • Adverse medical history or long-term medication • Prescribed medication (except for contraceptives - birthcontrol pills)

Design outcomes

Primary

MeasureTime frame
Microbiological composition

Secondary

MeasureTime frame
Biochemical, immunological and clinical effects

Contacts

Public ContactW. Crielaard

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)