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

Completed

Conditions: Milde gingivitis (milde tandvleesontsteking)
mild gingival inflammation

Registration Number: NL-OMON42247

Lead Sponsor: ACTA Dental research BV (ADR)

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 80

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
<p>The secondary study parameters are the biochemical and immunological effects<br /><br>e.g. the level of bleeding on marginal probing (BOMP), oral PMN numbers and<br /><br>function, saliva and level of dental plaque, oral malodor, the extent of tongue<br /><br>coating, and Gingival Crevicular Fluid (GCF).</p><br>