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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00033843

Enrollment

Registered

2024-03-11

Start date

2024-03-26

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

K12.0

Interventions

Group 1: Aphthe cohort (experimental group): - Sampling for the analysis of the oral microbiota (in oral samples, incl. aphtae) - Determination of the oral health status - Blood sampling - Questionnai

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

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

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)

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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 Blood test results Oral health status o Assessment of the condition of the dentition using the DMFT index Determination of the dental status (Decayed missing filled teeth score, DMFT) o Assessment of the condition of the periodontal situation using the Periodontal Screening Index (PSI) o Assessment of the condition of the gingival conditions using the Gingiva Index (GI according to Löe and Silness (1963)) o Assessment of oral hygiene at home using a plaque index (Plaque Control Record (PCR) according to O'Leary et al. (1972))	—

Measure

Time frame

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 Blood test results Oral health status o Assessment of the condition of the dentition using the DMFT index Determination of the dental status (Decayed missing filled teeth score, DMFT) o Assessment of the condition of the periodontal situation using the Periodontal Screening Index (PSI) o Assessment of the condition of the gingival conditions using the Gingiva Index (GI according to Löe and Silness (1963)) o Assessment of oral hygiene at home using a plaque index (Plaque Control Record (PCR) according to O'Leary et al. (1972))

—

Countries

Germany

Contacts

Public ContactAli Al-Ahmad

UNIVERSITÄTSKLINIKUM FREIBURG Department f. Zahn-, Mund- u. Kieferheilkunde Klinik für Zahnerhaltungskunde und Parodontologie

Ali.al-ahmad@uniklinik-freiburg.de076127048940

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026