Clinical exploratory study on the relationship between recurrent aphthous stomatitis and the oral microbiota, nutrient balance and other health parameters.

Recruiting

• Conditions: K12.0; Recurrent oral aphthae

• Registration Number: DRKS00033843
• Lead Sponsor: IVERSITÄTSKLINIKUM FREIBURG Department f. Zahn-, Mund- u. Kieferheilkunde Klinik für Zahnerhaltungskunde und Parodontologie

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-11
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Aphthous cohort: recurrent aphthae
- Healthy cohort: no occurrence of aphthae to date
- Non-smoker
- Last tooth brushing at least 12 hours ago
- Fasting for blood collection (8 to 12 hours without eating or drinking
nothing to drink (except water))

Exclusion Criteria

- Pregnancy
- Breastfeeding
- smoker
- Serious general illness (diabetes mellitus, oncological diseases,
immunosuppression oncological diseases, immunosuppression, e.g. due
to HIV infection, blood diseases)
- chronic immunological diseases (e.g. Crohn's disease, coeliac disease,
lichen planus)
- rheumatic diseases (e.g. Behçet's syndrome)
- Periodontitis and chronic oral mucosal diseases
- Use of antibiotics/immunosuppressants within the last 6 months
- Use of mouth rinses in the last 4 weeks
- Use of toothbrushes for the tongue in the last 4 weeks
- Treatment of acute aphthae with medication/home remedies (e.g.
Tea tree oil, rhubarb extract, cortisone, analgesic gels)

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Oral microbiota of test subjects with and without recurrent aphthae from swabs of the oral mucosa and the base of the aphthae (cohort aphthae) as well as saliva and supragingival plaque.

Secondary Outcome Measures

Name	Time	Method
Scores from the RKI-DEGS nutrition questionnaire, the patient-related aphthae questionnaire and the OHIP-G 14 questionnaire on oral health-related quality of life <br><br>Blood test results<br><br>Oral health status <br>o Assessment of the condition of the dentition using the DMFT index Determination of the dental status (Decayed missing filled teeth score, DMFT) <br>o Assessment of the condition of the periodontal situation using the Periodontal Screening Index (PSI)<br>o Assessment of the condition of the gingival conditions using the Gingiva Index (GI according to Löe and Silness (1963))<br>o Assessment of oral hygiene at home using a plaque index (Plaque Control Record (PCR) according to O'Leary et al. (1972))