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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON42247

Enrollment

Registered

2015-01-30

Start date

2015-02-11

Completion date

Unknown

Last updated

2024-04-23

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

Conditions

Milde gingivitis (milde tandvleesontsteking) mild gingival inflammation

Interventions

The challenge intervention is based on a full mouth experimental gingivitis protocol (Löe et al., 1965). For this, subjects will be requested to refrain from any form of oral hygiene for two weeks,

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Adults, >= 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 >= 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:

Design outcomes

Primary

Measure	Time frame
The primary outcome of this study will be the exploration of the dynamic biological process as assessed by changes in the microbiota of the different niches of the oral cavity, i.e. the microbiological composition of saliva, dental plaque (from the lingual aspect of the lower jaw, interproximal, sub gingival, supra gingival) and soft tissue (tongue dorsum (anterior and posterior) lateral border of the tongue, hard palate, attached gingival tissue). The secondary study parameters are the biochemical and immunological effects e.g. the level of bleeding on marginal probing (BOMP), oral PMN numbers and function, saliva and level of dental plaque, oral malodor, the extent of tongue coating, and Gingival Crevicular Fluid (GCF).	—

Measure

Time frame

The primary outcome of this study will be the exploration of the dynamic biological process as assessed by changes in the microbiota of the different niches of the oral cavity, i.e. the microbiological composition of saliva, dental plaque (from the lingual aspect of the lower jaw, interproximal, sub gingival, supra gingival) and soft tissue (tongue dorsum (anterior and posterior) lateral border of the tongue, hard palate, attached gingival tissue). The secondary study parameters are the biochemical and immunological effects e.g. the level of bleeding on marginal probing (BOMP), oral PMN numbers and function, saliva and level of dental plaque, oral malodor, the extent of tongue coating, and Gingival Crevicular Fluid (GCF).

—

Secondary

Measure	Time frame
The secondary study parameters are the biochemical and immunological effects e.g. the level of bleeding on marginal probing (BOMP), oral PMN numbers and function, saliva and level of dental plaque, oral malodor, the extent of tongue coating, and Gingival Crevicular Fluid (GCF).	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)